FDA Adverse Event
Death
Summary report: N
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS
MDR report key: 1131765
·
Received August 21, 2008
Report
- Report Number
- 6000002-2008-08487
- Event Type
- Death
- Date Received
- August 21, 2008
- Date of Event
- July 23, 2008
- Report Date
- August 12, 2008
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- LWR
- PMA / PMN Number
- P860057
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAS EXPIRED IN 2008, AFTER AN IMPLANT DURATION OF APPROXIMATELY 2 MONTHS. REPORTEDLY, THE PATIENT'S DEMISE WAS RELATED TO COMPLICATIONS OF HER SURGERY. IT IS UNKNOWN IF THE DEVICE IS AVAILABLE FOR RETURN AS NO OTHER DETAILS WERE PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS | REPLACEMENT HEART VALVE | LWR | EDWARDS LIFESCIENCES | 2700 | R08B0234 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Death |