MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-02-08 for COR-KNOT MINI? 031350 manufactured by Lsi Solutions, Inc..
[136178692]
The following narrative will provide our incomplete understanding of the event descriptions leading to this very unfortunate patient injury. While we still do not have a clear understanding what actually happened in the operating room that day, we can cite three different primary sources (one written and two verbal reports) for the information provided to us so far regarding this event. The written information is from the medwatch report filed by the hospital received by us on february 4, 2019. The initial verbal report from a hospital representative was received by our company through our sales consultant for that hospital on january 9, 2019. A follow-up discussion occurred between the lead surgeon caring for this patient and two employees of our company on (b)(6) 2019. Written description source: medwatch report. The above medwatch (report number (b)(4)), reported by a legal secretary for the hospital, does not report the specific date of the reported event or the date of the report filing. The patient is a male of unknown age. The hospital representative states the original intended procedure was as "minimally invasive aortic valve replacement. In this medwatch report, they describe this event: "doctor was using cor knot device during the replacement of an aortic valve, the device misfired causing a cor knot needle to enter the aorta, causing an injury to the aorta. Device was removed from service. The inspiris aortic valve which had been put in was removed, the hole fixed and a new replacement inspiris valve was put in. " initial primary verbal description source: operating room supply coordinator. On (b)(6) 2019, the hospital's operating room supply coordinator contacted this company's local sales representative by phone to report that, "according to the surgeon, during an avr, a cor-knot mini combo kit was used. The first knot did crimp right. The second knot did not perform right. While dealing with the second knot, device slipped and dissected the left main artery. " next primary verbal description source: surgeon. On (b)(4) 2019, two company employees visited the primary surgeon and a surgical fellow in an operating room hallway by pre-arranged appointment for an approximately 10 minute in-person discussion of this event. The following description is paraphrased based on notes taken during this meeting and recollection of the discussion: the surgery was intended to be an aortic valve replacement through partial sternotomy access. The surgeon was unclear whether the event he described occurred with the second or third attempt to place a titanium fastener on the sutures previously placed in the aortic annulus. The first cor-knot? Fastener was said to successfully crimp onto the first set of suture ends using the first cor knot mini? Device in the kit. The second device in the cor-knot mini? Kit was used on the second set of suture ends. The second device either worked well or (if the event occurred with second suture) it was with the second device that the surgeon reported feeling a "jerking motion"' which led him to remove the device with its retained titanium fastener un-crimped still in the tip of the device. If the second device worked well and without the reported event, then the "jerking motion" applied to the third suture, which would have involved the first device used again. Whether it was the second suture (i. E. Second device) or third suture (i. E. First device), the surgeon reportedly cut the suture to remove it along with the pledget held by the suture. The cor-knot mini? Device reportedly associated with the "jerking motion" was set aside and not used again. The surgeon continued to place all of the remaining titanium fasteners with the other device around the edwards inspiris 25 valve without issue. After all knots were placed a tear, not a dissection, in the main left coronary artery was discovered. A full sternotomy was performed. The sutures, knots and prosthetic valve that had been already placed were removed. Repairs were made to the artery. A new edwards inspiris 23 valve was placed again using the cor-knot mini? Titanium fasteners. This verbal discussion did not specifically identify who placed the titanium fastener in question, their experience level, whether the titanium fastener in question was located near the left coronary ostia in the aortic root, how the presumably sub-annularly placed pledget was retrieved after cutting the associated suture, if the injury was noted on the arrested heart or after coming off of by-pass, or why a smaller edwards inspiris 23 valve was put in the second time instead of another 25, etc.? Despite repeated requests, we have been consistently denied the opportunity to conduct our standard engineering structural and functional evaluation of the devices reportedly involved. On january 9th, per our standard practice, we immediately requested to have both cor-knot mini? Devices in question returned to us. Unexpectedly, we were informed that the devices would not be released and had been sent to the hospital's legal department. We were redirected to a person in that legal department. We reached out to the legal department 5 times between (b)(4) 2019 until we finally received a phone call back from the legal department on (b)(4). We were told that the hospital was not willing to return the devices to us for evaluation, despite our offer to cover all expenses and to provide shipping materials. On (b)(4) 2019, we requested in writing to the hospital's legal department the opportunity to perform our routine evaluation consistent with what has proven to be previously acceptable to every other hospital we have ever worked with. We arranged to travel to a room set up by their legal department for purposes of viewing and photographing, but were restricted to only touching the devices for photographic positioning but explicitly we were not permitted to squeeze the levers or test the devices. On (b)(4), we were able to take some photographs of both retained devices in a dimly lit room, which yielded inadequate images, especially of the small features of the distal device tip. At the (b)(4) photograph session, we were able to confirm the consistency of the cor-knot mini? Devices by the unique identifiers printed on the purple levers of each device with the previous lot descriptions provided along with several observations noted below. The two device levers in question are shown, and they correspond to devices 311 and 310 from manufacturing lot 736728. The retained manufacturing records regarding these specific devices, along with all of the other devices shipped with this lot, demonstrated that they were all tested and performed within specification. Our company's preliminary and limited engineering report on january 30th based on the inadequate january 30th photographs is provided below: subject: re: device inspection for complaint (b)(4) at (b)(6) hospital. Status update: photographs provided offer inconclusive appearance of device tip detail, however what is known; levers are fully forward and in proper resting position. Suture slots do not appear to have exposed cutting blades, indicating pwts are retracted. Handles appear properly welded and device shafts appear straight and aligned. Device #311 contains a titanium fastener within the tip (crimped vs. Uncrimped unknown). Device #310 molded fin adaptor is rotated 180? From manufactured position indicating it was used during the procedure. Unknown correlation between of "first device" and "second device" with device #310 and #311 in complaint description. Confirmation of a second visit to (b)(6) hospital has been schedule for thursday (b)(4) 2019 @ 9am. Xx will be attending this visit along with xx {names redacted}. Digital microscope to take high magnification photographs will be used. On (b)(4) 2019, the legal department agreed to allow us to return on (b)(4) to attempt better photographs (but still disallowing functional evaluation). Our scheduled appointment for (b)(4) was cancelled by the hospital late on the afternoon of (b)(4) while the engineer was already travelling to the hospital located in another state. The next opportunity for more photography is purportedly (b)(4) (but still no functional evaluation). The hospital has been informed of our company's mandatory requirement to respond to such events within 30 days via medwatch and that their abrupt cancellation of the second photographic session, along with their repeatedly denying a functional evaluation of these devices and continued failure to provide relevant information will, at least temporarily, compromise the understanding of the actual event. This current report is filed today in order to comply with 30 day reporting requirements with an understanding we will file a supplemental report with the higher quality photos after that visit (if it is not also cancelled). We also will continue to request the opportunity to appropriately evaluate the performance of the devices alleged as having a product problem. We will respectfully continue to provide supplements as meaningful information becomes known to us. Analysis: of these three varying and confusing event descriptions, we currently believe that the most accurate event description is that from the primary surgeon provided on (b)(6). Repeated requests for more information remain unanswered. The refusal of our requests to examine and test the devices in question is unique experience for our company. Devices are typically returned to our facility for our protocol driven standard thorough evaluation conducted by engineers specializing in the assessment of devices after customer use. Rarely, we have had to test devices at hospital locations when hospitals insist on retaining the devices. This is the first time the functional evaluation of the devices in question has been denied. We believe that it is everyone's best interest to find out what happened here. If there is a technical problem with our product that requires addressing, we would strongly prefer to aggressively pursue a solution as soon as possible. The written medwatch description filed by the hospital is awkward and confusing ("the device misfired causing a cor knot needle to enter the aorta, causing an injury to the aorta"); there is no needle in the cor-knot? Device. While both verbal reports provided more cogent information, inconsistencies and contradictions were not eliminated. With timely and adequate further discussion with the surgeon and with all others in the operating room during this event, along with a routine evaluation of the device in question, we believe the root cause or causes leading to this injury can be more accurately ascertained. Clearly, the device or devices described in the medwatch as a product problem and allegedly attributed to this adverse outcome, should be thoroughly evaluated. We have sincerely tried. While a "product defect" or "malfunction" could help explain why an operation does not go as planned, even in the event that a manufacturing defect is found, it does not necessarily mean that the specific injury was caused by this device. Please recall the primary surgeon has reported when the "jerking motion" was encountered, the device in question was not fired, but rather withdrawn from the surgical field with the uncrimped titanium fastener. This device was removed from use, set aside and is consistent with one of the devices photographed and still retaining a probably un-crimped fastener as described. Therefore, since the device was not activated to crimp the titanium fastener, the device's function as a surgical titanium fastener crimping tool is not at issue here. Rather, did the device inside of the aorta somehow cause the "jerking motion" and did the "jerking motion" somehow cause a tear injury to the left main coronary artery located on the outside of the aorta. Also note that the cor-knot mini? Technology guide instructions for use, page 2, states "users should be familiar with standard procedures and techniques involving surgical suture and titanium usage before employing the cor-knot mini? Device... " and continues "adequate cor-knot? Fastener security requires reasonable clinical judgment and appropriate surgical techniques as warranted by surgical circumstances and the experience of the surgeon. " this ifu also instructs under inside of patient, page 3, "9. Slide the cor-knot? Device distal tip gently over the partially tensioned suture down to the targeted site. " (b)(4). We do not understand how the reported tear in the left main coronary artery occurred. Coronary arteries are outside of the wall of aortic tissue surrounding the area of titanium fastener placement. While coronary artery ostia do emanate from inside of the aortic root, this event was not reported as an ostial tear, but rather a left main coronary artery tear. Coronary ostia are known to have significant variability in location and height from the annulus, sometimes even the number of coronary ostia can be variable across patient populations. During surgical aortic valve replacement, the leaflets of the aortic valve are dissected and resected to remove pathologic tissue along with the native leaflet tissue thereby freeing up room for the prosthetic replacement valve. Occasionally, during leaflet resection, especially with highly calcific aortic valves, injuries can occur to the adjacent supra-annular, annular and sub-annular tissue structures, such as aortic wall perforations or coronary ostial damage. Upon recognition of possible damage, assessment is made. If in the judgement of the surgeon repair is required, most injuries requiring additional attention are repaired without any long term negative sequelae. Rarely, despite expert efforts, patient outcomes can be adversely effected. Routine annular suture placement (usually of at least 12 individual sutures, each with a needle at both ends) typically requires manual manipulation of two needles passed from the inside of the left ventricle up through the annulus towards the aorta. While usually very effective and atraumatic, suture placement can also occasionally lead to patient injury. Sutures placed in the aortic annular tissue must be then placed correspondingly into the sewing cuff of the prosthetic valve. Sutures placed too far on the periphery of the sewing cuff can lead suture tails from hand-tied knots or from sutures fastened with titanium fasteners to acutely or chronically damage or erode adjacent structures inside of the aorta. The approximately 4mm diameter of the cor-knot mini? Device tip is generally accepted as smaller and less traumatic than the surgeon's gloved tying finger to the delicate tissue structures in the narrow space between prosthetic leaflets and valve struts and the sinuses of the aortic root. Figs. 2a and 2b show two enlarged views of the distal tip and device shaft of a cor-knot mini? Device with its atraumatically designed tip profile relative to a gloved finger of a small hand. However, even a relatively small 4mm diameter device tip can be driven into contact with delicate tissue structures if inappropriate visualization and routine care is not taken during utilization. Experienced surgeons routinely make every attempt to use care and caution while placing anything (e. G. , forceps, debridement rongeurs, scalpels, suction tips, needles, needle drivers, even the prosthetic valve during seating) into the delicate aortic root. Heart surgery is a very challenging process requiring excellent dexterity to accurately perform multiple precision steps typically while a patient is on cardiopulmonary bypass. Even outstanding technology that enhances dexterity and reliability, while quickening operative times can occasionally not be used as is instructed and required or not perform as intended. With normal, standard of care, use of cor-knot mini? Technology, damage to adjacent tissue structures, including coronary arteries, should be of extremely low risk. The multiple warnings and labels (warnings:... "direct contact with sensitive tissue structures (e. G. Pulsatile arteries, cardiac valve leaflets, valve chordae, etc. ) and foreign materials can lead to tissue injury and damage" - in the cor-knot mini? Technology guide provided in every package also make such precautions clear to most end-user surgeons throughout the world. Conclusion: we are very grateful to have heard indirectly that this patient has been discharged to home with no permanent problems related to this purported product problem. We will continue in our attempts to investigate the known realities of this event and to persist in trying to evaluate the devices in question. Despite all of the inconsistencies surrounding this event's description along with our inability to obtain routine information and test data from these sequestered devices. What is known: according to the primary surgeon, the function of the cor-knot? Device associated with the "jerking motion" is not at issue. The device was removed after feeling the "jerking motion" without being fired and with its loaded titanium fastener still in its distal tip. A cor-knot? Device with a titanium fastener consistent with this description was photographed along with another device without a fastener. The surgeon or surgeons continued to use the other device from the same kit after the second or third suture in question. The second valve was also secured successfully with this product. The hospital continues to buy and use this product. Cor-knot? Technology has a long history of acceptance in surgery across the world helping over 353,491 patients with nearly 6 million titanium fasteners delivered by nearly 700,000 devices, which are remarkably effective, have a very low rate of complaints and are proven to have a very low rate of any defects. The manufacturing lot of the device in question is consistent with the cor-knot? Products' long history of remarkable stability and reliability. What is not clear: a problem with this product has not been clearly demonstrated here. The cause of the tear injury to the left main coronary artery remains uncertain. Who was actually holding the device in question during the reported "jerking motion" has never been ascertained. With appropriate cooperation between the different people trying to do their best for this patient, we believe that we can still learn much about what actually transpired in the course of this important operation and this patient's subsequent care. We eagerly await confirmation that the patient continues to do well.
Patient Sequence No: 1, Text Type: N, H10
[136178693]
We do not have a clear understanding of this event. Please see below regarding our current perspective. The hospital's medwatch description as filed reads as follows: "doctor was using cor knot device during the replacement of an aortic valve, the device misfired causing a cor knot needle to enter the aorta, causing an injury to the aorta. Device was removed from service. The inspiris aortic valve which had just been put in was removed, the hole was fixed, and a new replacement inspiris aortic valve was put in. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1320468-2019-00001 |
| MDR Report Key | 8324235 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-02-08 |
| Date of Report | 2019-01-09 |
| Date of Event | 2019-01-07 |
| Date Mfgr Received | 2019-01-09 |
| Device Manufacturer Date | 2018-11-29 |
| Date Added to Maude | 2019-02-08 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. CHRISTOPHER MILLER |
| Manufacturer Street | 7796 VICTOR-MENDON ROAD |
| Manufacturer City | VICTOR NY 14564 |
| Manufacturer Country | US |
| Manufacturer Postal | 14564 |
| Manufacturer Phone | 5858696665 |
| Manufacturer G1 | LSI SOLUTIONS, INC. |
| Manufacturer Street | 7796 VICTOR-MENDON ROAD |
| Manufacturer City | VICTOR NY 14564 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 14564 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COR-KNOT MINI? |
| Generic Name | INSTRUMENT, LIGATURE PASSING, AND KNOT TYING |
| Product Code | HCF |
| Date Received | 2019-02-08 |
| Catalog Number | 031350 |
| Lot Number | 736328 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 1 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LSI SOLUTIONS, INC. |
| Manufacturer Address | 7796 VICTOR-MENDON ROAD VICTOR NY 14564 US 14564 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2019-02-08 |