FDA Adverse Event
Death
Summary report: N
CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS
MDR report key: 1891986
·
Received November 5, 2010
Report
- Report Number
- 2015691-2010-14329
- Event Type
- Death
- Date Received
- November 5, 2010
- Date of Event
- August 7, 2010
- Report Date
- October 6, 2010
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- DYE
- PMA / PMN Number
- P860057/S029
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED. THIS EVENT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY. THE PATIENT ALSO HAS OTHER RELATED EVENTS; PLEASE REFERENCE THE OTHER MEDWATCHES FILED UNDER PATIENT IDENTIFIER (B)(4). THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER VIA FAX, A RESPONSE WAS RECEIVED. UNFORTUNATELY, THE CAUSE OF DEATH WAS NOT PROVIDED. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAS EXPIRED AFTER AN IMPLANT DURATION OF APPROXIMATELY 0.03 MOTNHS. THE CAUSE OF DEATH WAS NOT PROVIDED. NO FURTHER DETAILS WERE REPORTED.
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 | R-09A0045 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR | Death |