MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional report with the FDA on 2020-03-27 for CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS 3300TFX manufactured by Edwards Lifesciences.
[188235059]
Tissue degeneration related structural deterioration either calcific or non-calcific are common chronic failure modes for this type of bioprosthetic heart valves. The operational mechanical stress and biological factors are generally believed to be the major contributors to the non-calcific bioprosthetic tissue degeneration. Structural valve deterioration (svd) can, and typically does, lead to chronic central leaks over a period of time. Svd is the most common reason for bioprosthesis explant and encompasses multiple failure modes, including calcification, noncalcific degeneration, dehiscence, cusp thickening or fibrosis, or a combination of these. Such failure modes may occur singularly or concomitantly. The device was not returned for evaluation, as it remains implanted. The root cause of this event cannot be conclusively determined. However, it is likely that patient related factors and the progression of the underlying valvular disease pathology contributed to the event. The device history record (dhr) was reviewed and showed that this device met all manufacturing and sterilization specifications for product release prior to distribution. No issues were identified that would have impacted this event. 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
[188235060]
Edwards received a notification that the implanted 27mm valve was scheduled for a re-do avr after an implant duration of 4 years, 8 months. A septal myectomy is required to alleviate the symptoms of hypertrophic cardiomyopathy. Per patient the implanted valve demonstrated signs of wear and tear. Per medical records there is no valve degeneration, and the mild regurgitation observed in early post-op period has resolved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2015691-2020-11201 |
| MDR Report Key | 9890866 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-02 |
| Date of Event | 2020-03-02 |
| Date Mfgr Received | 2020-03-02 |
| Device Manufacturer Date | 2014-03-10 |
| Date Added to Maude | 2020-03-27 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. AMRITHA SRINIVASAN |
| Manufacturer Street | 1 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 | 2020-03-27 |
| Model Number | 3300TFX |
| Lot Number | S-14C0954 |
| Device Expiration Date | 2018-03-09 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EDWARDS LIFESCIENCES |
| Manufacturer Address | ONE EDWARDS WAY IRVINE CA 92614 US 92614 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2020-03-27 |