FDA Adverse Event
Death
Summary report: N
CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS
MDR report key: 1163044
·
Received September 12, 2008
Report
- Report Number
- 6000002-2008-08626
- Event Type
- Death
- Date Received
- September 12, 2008
- Date of Event
- July 9, 2008
- Report Date
- September 4, 2008
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- LWR
- PMA / PMN Number
- P860057/S016
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT HAS EXPIRED APPROX AFTER IMPLANT DURATION OF 1 MONTH, DUE TO "WORSENING UNDERLYING CARDIOPULMONARY DISEASE," AS LEARNED THROUGH THE HEALTH CARE PROVIDER. IT IS UNK IF THE DEATH WAS DEVICE RELATED. IT WAS ADDITIONALLY REPORTED THAT A SECOND DEVICE, MODEL # 4500, WAS IMPLANTED. REFER TO MFR # 6000002-2008-08627. NO FURTHER DETAILS WERE PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS | REPLACEMENT HEART VALVE | LWR | EDWARDS LIFESCIENCES | 6900P | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |