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 2020-02-07 for EDWARDS SAPIEN 3 TRANSCATHETER 9600TFX26A manufactured by Edwards Lifesciences.
[178207384]
The edwards sapien 3 transcatheter heart valve is indicated for patients with symptomatic heart disease due to severe native calcific aortic stenosis or failure 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. Per the instructions for use (ifu), valve regurgitation is a potential adverse event associated with bioprosthetic heart valves and the transcatheter mitral valve replacement (tmvr) procedure. There are multiple patient and procedural factors that alone or in combination can cause or contribute to valve regurgitation including, but not limited to, malposition of the valve, inaccurate measurement of the native valve annulus, uneven distribution of calcium on the native valve, bulky or severe calcification, a severely elliptical annulus shape, valve under-sizing. The thv training manuals instruct the operator on proper positioning and deployment of the valve, including all procedural and anatomical considerations. The patient screening manual instructs the operator on proper native valve leaflet assessment, taking into consideration the length, bulkiness and distribution of calcium on the native leaflets to determine whether valve performance will be impaired. In this case, there was no allegation or indication a product deficiency contributed to this adverse event.? The cause of the mitral regurgitation is unknown, however, may be due to patient factors and/or mechanisms (cardiac remodeling) described 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
[178207385]
A review of medical records showed approximately 2 weeks post valve in valve (viv) procedure with a 26mm sapien 3 valve in a previously implanted 26mm sapien 3 ultra valve in the mitral position, echo showed paravalvular leak (pvl) as well as moderate/severe regurgitation. The patient had a long and complicated hospital course, and would be extremely high risk for re-intervention at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2015691-2020-10437 |
| MDR Report Key | 9682994 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-07 |
| Date of Report | 2020-01-15 |
| Date of Event | 2019-11-29 |
| Date Mfgr Received | 2020-01-15 |
| Device Manufacturer Date | 2018-01-29 |
| Date Added to Maude | 2020-02-07 |
| 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 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EDWARDS SAPIEN 3 TRANSCATHETER |
| Generic Name | PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED |
| Product Code | NPU |
| Date Received | 2020-02-07 |
| Model Number | 9600TFX26A |
| Device Expiration Date | 2020-01-09 |
| 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. Other; 2. Required No Informationntervention | 2020-02-07 |