FDA Adverse Event
Malfunction
Summary report: N
CARPENTIER- EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS
MDR report key: 1150025
·
Received August 27, 2008
Report
- Report Number
- 6000002-2008-08534
- Event Type
- Malfunction
- Date Received
- August 27, 2008
- Date of Event
- August 15, 2008
- Report Date
- August 15, 2008
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- LWR
- PMA / PMN Number
- P860057/040
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED.
Description of Event or Problem · 1
IT WAS REPORTED THAT WHILE IMPLANTING THE DEVICE THE SURGEON HAD TO TIE HOLDING THE SUTURE TO KEEP THE VALVE FROM OPENING DURING THE PROCEDURE. REPORTEDLY, THE STRING THAT SECURES THE DEVICE IN PLACE AND PREVENTS SUTURE LOPPING BROKE DURING THE CASE. IT WAS REPORTED THAT THE VALVE WAS IMPLANTED.
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-07F1192 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR |