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 2020-03-31 for EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE 9600TFX26 manufactured by Edwards Lifesciences.
[185773953]
The valve was not returned to edwards lifesciences for evaluation. Information regarding the disposition of the valve was not provided. The instructions for use (ifu) lists cardiovascular injury that may require intervention (including perforation or dissection of vessels, ventricle, myocardium or valvular structures, annular tear or rupture) as a potential risk associated with the overall tavr procedure. Aorto-cardiac or intra-cardiac fistulas and shunts are relatively rare but can result from endocarditis, tissue trauma or rupture of cardiac aneurysms. They have been reported as a rare complication following surgical or transcatheter aortic valve replacement. This type of defect in the cardiac tissues or aortic wall can result from trauma during percutaneous aortic valve implantation, additional in-valve balloon dilation on a heavily calcified native aortic valve, or tissue erosion over time from calcified vegetations or the valve frame. Percutaneous or surgical closure of para-prosthetic leaks may be required to close the communication. In this case, there was no allegation or indication a device malfunction contributed to this adverse event. Based on the information provided, the exact cause for the intra-cardiac, shunt and subsequent pericardial effusion is unknown but maybe be related to patient factors (calcification) or procedural factors (manipulation of devices). 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
[185773974]
As reported by edwards affiliate in (b)(6), during a transfemoral tavr procedure, post deployment of a 26mm sapien 3 valve in a? Very calcified valve? , an echo performed showed mild/moderate paravalvular leak (pvl). The decision was to post dilate the valve, however, the blood pressure of the patient dropped, and cardiac massage was required. An angiogram showed the patient had a small shunt between the left and the right ventricle. The decision was then made to deploy a second valve in a slightly lower position in order to fill the shunt. The patient remained unstable. A small tamponade was observed and drained, however the patient expired. It was confirmed that the shunt was visible right after the initial valve deployment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2015691-2020-11245 |
| MDR Report Key | 9904568 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-10 |
| Date of Event | 2020-03-10 |
| Date Mfgr Received | 2020-03-10 |
| Device Manufacturer Date | 2019-11-26 |
| Date Added to Maude | 2020-03-31 |
| 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 | MRS. RENEE DORNE |
| Manufacturer Street | 1 EDWARDS WAY |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal | 92614 |
| Manufacturer Phone | 9492506385 |
| Manufacturer G1 | EDWARDS LIFESCIENCES LLC |
| Manufacturer Street | ONE 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 | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED |
| Product Code | NPT |
| Date Received | 2020-03-31 |
| Model Number | 9600TFX26 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EDWARDS LIFESCIENCES |
| Manufacturer Address | ONE EDWARDS WAY IRVINE CA 92614 US 92614 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Required No Informationntervention | 2020-03-31 |