MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-23 for EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE 9600TFX23 manufactured by Edwards Lifesciences.
[146041268]
(b)(4). Valve migration and regurgitation are potential risks associated with the use of the valve.? According to literature review, valve migration results when forces acting on the transcatheter heart valve (thv) overcome the strength of attachment of the valve to the landing zone. Less-than-severe and non-uniformly distributed calcification, incorrect valve sizing, and incomplete frame expansion, and can contribute to valve migration. Malposition is another risk factor for migration and regurgitation. If the valve is deployed too atrial, it may not cover the native mitral valve. As a result, the native mitral leaflet deflected flow, creating a venturi effect where a reduction in blood pressure resulting in mitral regurgitation. 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. , society of thoracic surgeons operative risk score =8% or at a =15% risk of mortality at 30 days).? Deployment of the sapien 3 valve in a native mitral valve is not indicated per the labeling; therefore the labeling (ifus and ew training manuals) do not instruct the operator how to position the sapien 3 valve in this scenario.? The device remains implanted in the patient. In this case, the cause of the valve migration and subsequent mitral insufficiency noticed one month post deployment of the s3 valve in the native mitral annulus cannot be determined. However, there was no allegation or indication of a device malfunction. It is possible that some of the risk factors mentioned above caused or contributed to the event. 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
[146041269]
As reported, approximately 1 month post transcatheter mitral valve replacement (tmvr) with a 29mm s3 valve in the native mitral position via transseptal approach, the patient developed mitral insufficiency and a 2nd valve was implanted.? Per report, the physician believed the 1st valve migrated and left the patient with mitral insufficiency.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2015691-2019-01850 |
| MDR Report Key | 8638674 |
| Date Received | 2019-05-23 |
| Date of Report | 2019-05-02 |
| Date of Event | 2019-05-02 |
| Date Mfgr Received | 2019-05-02 |
| Device Manufacturer Date | 2019-01-20 |
| Date Added to Maude | 2019-05-23 |
| 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 | 0 |
| Brand Name | EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE |
| Generic Name | PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED |
| Product Code | NPU |
| Date Received | 2019-05-23 |
| Model Number | 9600TFX23 |
| 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 | 2019-05-23 |