FDA Adverse Event
Death
Summary report: N
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS
MDR report key: 1110883
·
Received August 11, 2008
Report
- Report Number
- 6000002-2008-08393
- Event Type
- Death
- Date Received
- August 11, 2008
- Date of Event
- July 24, 2008
- Report Date
- July 24, 2008
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- LWR
- PMA / PMN Number
- P860057
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, 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. THE DATE OF PT'S DEATH AND IMPLANT DURATION ARE UNK, THEREFORE THE AWARE DATE IS BEING USED AS THE OCCURRENCE DATE. IT IS UK IF THE DEATH WAS DEVICE RELATED. IT WAS ADDITIONALLY REPORTED THAT A SECOND DEVICE. MODEL #2700, WAS EXPLANTED. REFER TO MFR #6000002-2008-08390. ALSO, THIRD DEVICE WAS IMPLANTED, MODEL #6900PTFX. REFER TO MFR #6000002-2008-08391.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS | REPLACEMENT HEART VALVE | LWR | EDWARDS LIFESCIENCES | 2700 | R-08D0847 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |