MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,s report with the FDA on 2020-02-10 for CARPENTIER-MCCARTHY-ADAMS IMR ETLOGIX? MITRAL ANNULOPLASTY RING 4100 manufactured by Edwards Lifesciences.
[178564582]
The device was not returned to edwards for evaluation. Ring dehiscence may occur early or late. When it occurs in the early post-operative period, it is typically a result of an inadequate valve repair in combination with friable myocardial tissue. Late dehiscence can occur as a result of successive dilatation of cardiac structures that result from progression of disease or from endocarditis. 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. A definitive root cause cannot be determined. Edwards lifesciences will continue to monitor all reported events. No further actions are required at this time.
Patient Sequence No: 1, Text Type: N, H10
[178564583]
Edwards received notification that this 32mm ring was explanted after an implant duration of 24 days due to ring dehiscence leading to mitral valve regurgitation. The explanted device was replaced with a non-edwards valve. The outcome was noted as resolved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2015691-2020-10467 |
| MDR Report Key | 9689754 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,S |
| Date Received | 2020-02-10 |
| Date of Report | 2020-01-16 |
| Date of Event | 2019-12-23 |
| Date Mfgr Received | 2020-01-16 |
| Device Manufacturer Date | 2019-01-10 |
| Date Added to Maude | 2020-02-10 |
| 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 | 1 EDWARDS WAY MLE2 |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal | 92614 |
| Manufacturer Phone | 9492504062 |
| Manufacturer G1 | EDWARDS LIFESCIENCES |
| Manufacturer Street | 1 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-MCCARTHY-ADAMS IMR ETLOGIX? MITRAL ANNULOPLASTY RING |
| Generic Name | RING, ANNULOPLASTY |
| Product Code | KRH |
| Date Received | 2020-02-10 |
| Model Number | 4100 |
| Lot Number | 6647340 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2020-02-10 |