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 CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS 3300TFX manufactured by Edwards Lifesciences.
[187856564]
Stenosis and/or regurgitation, which develops progressively over time, can be due to a number of issues. Additionally, there can be a number of potential known and unknown patient related contributing factors. Structural valve deterioration (svd), a common reason for bioprosthesis explant or reoperation, encompasses multiple failure modes, including calcific and non-calcific degeneration, dehiscence, cusp thickening or fibrosis, or a combination of these. Such failure modes, occurring singularly or concomitantly, may contribute to stenosis and/or regurgitation. Alternatively, nonstructural dysfunction (nsvd) may also play a role in the development of valvular stenosis and/or regurgitation. Stenosis and/or regurgitation is most commonly related to patient factors, and is not usually an indication of a device malfunction. The device was not returned for evaluation, as it remains implanted. Minimal information regarding this procedure was received and attempts to get additional information regarding the condition of the device, patient's medical history, or possible comorbidities have been unsuccessful. The root cause of the event remains indeterminable. If new information becomes available, a supplemental report will be submitted. The device history record (dhr) was not able to be reviewed as the device serial number was not provided. Edwards will continue to review and monitor all events. Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.
Patient Sequence No: 1, Text Type: N, H10
[187856565]
Edwards received notification that an aortic valve was disabled via a valve-in-valve replacement after an approximate implant duration of 5 years due to stenosis and regurgitation. A non-edwards valve was implanted. The patient was noted as to be recovering after the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2015691-2020-11255 |
| MDR Report Key | 9908640 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-06 |
| Date of Event | 2020-02-20 |
| Date Mfgr Received | 2020-03-06 |
| 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 | MS. AMRITHA SRINIVASAN |
| Manufacturer Street | ONE EDWARDS WAY MLE-2 |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal | 92614 |
| Manufacturer Phone | 9492504062 |
| 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 | CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS |
| Generic Name | HEART-VALVE, REPLACEMENT |
| Product Code | DYE |
| Date Received | 2020-03-31 |
| Model Number | 3300TFX |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| 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. Hospitalization; 2. Required No Informationntervention | 2020-03-31 |