MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-25 for EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE, 26MM 9600TFX26 manufactured by Edwards Lifesciences.
[125102899]
The edwards sapien 3 transcatheter heart valve is indicated for patients with symptomatic heart disease due to failure (stenosed, insufficient, or combined) of a surgical bioprosthetic aortic or mitral valve who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (i. E. , predicted risk of surgical mortality = 8% at 30 days, based on the sts risk score and other clinical co-morbidities unmeasured by the sts risk calculator). Per the instructions for use (ifu), left ventricle outflow tract (lvot) obstruction is a known potential complication associated with the use of the sapien 3 valve and in patients who undergo transcatheter mitral valve replacement. In most cases of postoperative lvot obstruction, the obstruction results from the protrusion of the valve into the lvot or from abnormal subvalvular positioning of the prosthesis. Additionally, lvot obstruction may occur postoperatively if there is a narrowed mitral-aortic angle, or due to a thickened interventricular septum. Other possible causes include a hyper contractile left ventricle or atrial fibrillation. Obstruction of the left ventricular outflow tract can also be caused by patient factors (anterior mitral leaflet protruding into the lvot). Depending on the degree of obstruction, cardiac output and hemodynamic stability may be affected. Inaccurate deployment is generally a result of use error or a combination or patient and procedural factors. In some cases lvot obstruction could result in clinically significant hemodynamic compromise that may require explanation of the thv with surgical correction. The thv training manuals instruct the operator on proper positioning and deployment of the valve, including all procedural and anatomical considerations. Physicians are extensively trained by edwards before they are qualified to use the sapien 3 thv. Training includes patient screening, device preparation, approach, deployment, imaging, procedure-specific training manuals and proctored procedures. The correct alignment and positioning of the device at the point of deployment is emphasized as a key factor to the placement and fixation of the device. Operators are also instructed to use fluoroscopy as the primary method of visualization for positioning and deployment. In this case, the device is not available for evaluation as it remains implanted in the patient. There was no allegation or indication a device malfunction contributed to this adverse event. As reported, the lvot obstruction was likely caused by the long anterior native mitral leaflet. The ifu and training manuals have been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device. Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review. No corrective or preventative actions are required.
Patient Sequence No: 1, Text Type: N, H10
[125102900]
As reported during the transcatheter cardiovascular therapeutics (tct) conference presentation,? Case presentation: left ventricular outflow tract obstruction? , a patient with a 30mm physio 2 annuloplasty ring developed severe mitral regurgitation. A 26mm sapien 3 valve was implanted within the physio ii ring and systolic anterior motion (sam), turbulent lvot flow, and lvot gradient of 100mmhg was observed. The anterior mitral leaflet length was 23mm, 12. 5mm beyond the sapien 3 frame. The patient was managed medically, however, was more breathless than before tmvr and had ruby colored urine and biochemical hemolysis. A? Rescue? Lampoon procedure was performed and the anterior mitral leaflet was split/lacerated. The lvot gradient was 20mmhg, there was no sam, and normalized flow.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2015691-2018-04387 |
| MDR Report Key | 8007525 |
| Date Received | 2018-10-25 |
| Date of Report | 2018-10-01 |
| Date of Event | 2018-09-24 |
| Date Mfgr Received | 2018-10-01 |
| Date Added to Maude | 2018-10-25 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. FRANCES PRESTON |
| Manufacturer Street | 1 EDWARDS WAY |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal | 92614 |
| Manufacturer Phone | 9492505190 |
| Manufacturer G1 | EDWARDS LIFESCIENCES LLC |
| Manufacturer Street | 1 EDWARDS WAY |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92614 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE, 26MM |
| Generic Name | PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED |
| Product Code | NPU |
| Date Received | 2018-10-25 |
| Model Number | 9600TFX26 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EDWARDS LIFESCIENCES |
| Manufacturer Address | 1 EDWARDS WAY IRVINE CA 92614 US 92614 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-10-25 |