MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-11-01 for EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE 9600TFX29 manufactured by Edwards Lifesciences.
[125908558]
The valve was discarded by the facility. Potential risks associated with the overall procedure including potential access complications associated with standard cardiac catheterization, balloon valvuloplasty, the potential risks of conscious sedation and/or general anesthesia, and the use of angiography include device migration or malposition requiring intervention. The edwards sapien 3 transcatheter heart valve, model 9600tfx, and accessories are indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a heart team, including a cardiac surgeon, to be at intermediate or greater risk for open surgical therapy (i. E. , predicted risk of surgical mortality = 3% at 30 days, based on the (b)(6) risk score and other clinical co-morbidities unmeasured by the sts risk calculator). The edwards sapien 3 transcatheter heart valve, model 9600tfx, and accessories are 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). ? Review of the instructions for use (ifu) indicates the following: patients with pre-existing bioprostheses should be carefully assessed prior to implantation of the valve to ensure proper valve positioning and deployment. Additional precautions for transseptal replacement of a failed mitral valve bioprosthesis include, presence of devices or thrombus or other abnormalities in the caval vein precluding safe transvenous femoral access for transseptal approach; presence of atrial septal occluder device or calcium preventing safe transseptal access. ? The patient screening and procedural training manual prescribes specific testing to determine suitability for delivering the thv in the mitral position, valve-in-valve. Proper imaging screening includes a good quality echocardiogram, ct (with contrast is preferred) and coronary angiogram; a right heart cath is optional. The manual advises that the measured internal orifice diameters (of the pre-existing surgical valve) may be smaller than the manufacturer? S internal diameter and labeled valve size, due to various mechanisms of bioprosthetic valve failure (i. E. Calcification, pannus). Overall assessment and actual internal dimensions of the pre-existing bioprosthetic valve are critical. Specific guidance is given for crossing the interatrial septum. Determine adequate puncture location using tee. Perform transseptal puncture using standard techniques under tee guidance. Dilate the atrial septum with a 10-14mm, 40mm length septostomy balloon. Advance. 035? Guidewire over a guiding catheter into the left ventricle. Guidance is given for guidewire placement as well. Depending on the patient? S anatomy, different techniques may be considered for guidewire placement:? Stiff wire parked and looped in the lv apex, stiff wire snared and externalized the lv apex? Apical rail? Or stiff wire externalized through the femoral artery? Av femoral rail?. In this case, there was no allegation of an edwards device deficiency or malfunction. The canted position of the thv was attributed to the? Inadequate position of the puncture of the transseptal approach access?. 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
[125908559]
As reported by our affiliates in (b)(4), the 29mm sapien 3 valve was placed in the mitral position inside a previously implanted (unknown type) mitral valve (viv procedure) by transseptal approach. The sapien 3 valve was implanted in a? Non-straight/flat position, one part in atrial and the other ventricular due to the non-adequate position of the puncture of the transseptal approach access?. The case was converted to open transthoracic surgery to remove the sapien 3 valve, and to deploy another sapien 3 valve successfully. The surgery was successful but the patient expired on pod2 for reasons not related with the sapien 3 implantation according to the physicians.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2015691-2018-04514 |
| MDR Report Key | 8031507 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-11-01 |
| Date of Report | 2018-10-09 |
| Date of Event | 2018-09-27 |
| Date Mfgr Received | 2018-10-09 |
| Device Manufacturer Date | 2018-05-15 |
| Date Added to Maude | 2018-11-01 |
| 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 | 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 | 3 |
| Brand Name | EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE |
| Generic Name | PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED |
| Product Code | NPU |
| Date Received | 2018-11-01 |
| Model Number | 9600TFX29 |
| 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 | 2018-11-01 |