FDA Adverse Event
Injury
Summary report: N
CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS
MDR report key: 1820092
·
Received August 30, 2010
Report
- Report Number
- 2015691-2010-13965
- Event Type
- Injury
- Date Received
- August 30, 2010
- Date of Event
- May 31, 2010
- Report Date
- August 9, 2010
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- DYE
- PMA / PMN Number
- P860057/S029
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED. THE EVENT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY. THROUGH FOLLOW UP WITH THE HEALTH CARE PROVIDER (VIA FAX), ADDITIONAL INFORMATION WAS RECEIVED. IT WAS LEARNED THAT THE DEVICE WAS DISCARDED. A COPY OF THE OPERATIVE REPORT WAS ALSO REQUESTED, BUT NOT PROVIDED. THE DEVICE HISTORY RECORD (DHR) REVIEW HAS BEEN COMPLETED, AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 6.47 MONTHS. THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER, IT WAS LEARNED THAT THE DEVICE WAS EXPLANTED DUE TO ENDOCARDITIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS | REPLACEMENT HEART VALVE | DYE | EDWARDS LIFESCIENCES | 7000TFX | 08J236 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Required Intervention |