FDA Adverse Event
Death
Summary report: N
CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS
MDR report key: 1131784
·
Received August 22, 2008
Report
- Report Number
- 6000002-2008-08496
- Event Type
- Death
- Date Received
- August 22, 2008
- Report Date
- August 13, 2008
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- LWR
- PMA / PMN Number
- P860057/040
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SUTURE LOOP. DEVICE NOT RETURNED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE SURGEON SUTURE LOOPED THE STRUT. REPORTEDLY, THE POST OP TEE REVEALED REGURGITATION. THE PATIENT EXPIRED; HOWEVER, THE SURGEON HAS DISASSOCIATED THE DEVICE FROM THE PATIENT'S DEATH. IT WAS REPORTED THAT THE PROCEDURE INVOLVED A VERY ILL PATIENT WHO WAS UNDERGOING A TRIPLE VALVE PROCEDURE.
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-08B0340 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Death| R |