FDA Adverse Event
Death
Summary report: N
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS
MDR report key: 1233260
·
Received November 12, 2008
Report
- Report Number
- 6000002-2008-09267
- Event Type
- Death
- Date Received
- November 12, 2008
- Date of Event
- September 18, 2008
- Report Date
- November 5, 2008
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- LWR
- PMA / PMN Number
- P860057
- 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 MOS, DUE TO UNK REASONS. IT IS UNK IF THE DEATH WAS DEVICE RELATED. NO FURTHER DETAILS WERE PROVIDED. INFO LEARNED FROM IMPLANT PATIENT REGISTRY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS | REPLACEMENT HEART VALVE | LWR | EDWARDS LIFESCIENCES | 2700 | R08E0943 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |