FDA Adverse Event
Death
Summary report: N
CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS
MDR report key: 1060306
·
Received June 12, 2008
Report
- Report Number
- 6000002-2008-07540
- Event Type
- Death
- Date Received
- June 12, 2008
- Date of Event
- April 11, 2008
- Report Date
- May 14, 2008
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- LWR
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT EXPIRED IN 2008 DUE TO UNKNOWN REASONS. IMPLANT DURATION 14 DAYS. IT WAS UNKNOWN OF DEATH IS DEVICE RELATED. NO FURTHER DETAILS WERE PROVIDED. INFO LEARNED FROM IMPLANT PT REGISTRY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS | REPLACEMENT HEART VALVE | LWR | EDWARDS LIFESCIENCES | 6900PTFX | R-07M2452 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |