MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-02-04 for EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE 9600TFX29A manufactured by Edwards Lifesciences.
[177986018]
Udi reference number (b)(4). The valve was not returned to edwards lifesciences, as it remains implanted in the patient. Per the instructions for use (ifu), paravalvular leak (pvl) is a potential adverse event associated with bioprosthetic heart valves and the transcatheter mitral valve replacement (tmvr) procedure. The patient screening manual and the procedure didactic identify several procedural and anatomical factors which could contribute to pvl, including device malposition, inaccurate measurement of the native valve annulus, uneven distribution of calcium on the native valve, bulky or severe calcification, an elliptical annulus shape and valve under-sizing. Physicians are extensively trained by edwards before they are qualified to use the sapien thv. The patient screening manual instructs the operator on proper mitral valve and root assessment, including the use of echo, aortogram and ct to appropriately measure the annulus diameter, content and distribution of calcium, and leaflet characteristics. Contraindications, important considerations when assessing the valve and choosing the proper thv are also discussed. The thv training manuals also instruct the operator on proper positioning and deployment of the valve, including all procedural and anatomical considerations. Device preparation, approach, deployment, imaging, procedure specific training manuals and proctored procedures are also included. In this case, there was no allegation or indication a device malfunction contributed to this adverse event. The cause of the pvl is unknown but may be due the factors mentioned above. 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
[177986019]
As reported, during a transapical tmvr procedure, after successful laceration of the anterior mitral valve leaflet to prevent outflow track obstruction procedure, (lampoon) and deployment of the 29 sapien 3 valve, echo showed the patient had moderate-severe perivalvular leak (pvl). A second 29mm sapien 3 valve was deployed in order to treat the pvl, as it was believed the source of the leak was through the open struts of the first valve implant. This made things markedly better, however the leak was still considered moderate. A vascular plug was then deployed, outside of both valves, resolving the pvl. The patient required cpb support during the procedure and left the operating room on ecmo. It is perceived that the pvl was caused by patient factors.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2015691-2020-10375 |
| MDR Report Key | 9665995 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-04 |
| Date of Report | 2020-01-15 |
| Date of Event | 2020-01-15 |
| Date Mfgr Received | 2020-02-04 |
| Device Manufacturer Date | 2019-10-29 |
| Date Added to Maude | 2020-02-04 |
| 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 | RN 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 | 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 | PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED |
| Product Code | NPU |
| Date Received | 2020-02-04 |
| Model Number | 9600TFX29A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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. Required No Informationntervention | 2020-02-04 |