FDA Adverse Event
Injury
Summary report: N
CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS
MDR report key: 1133258
·
Received August 21, 2008
Report
- Report Number
- 6000002-2008-08484
- Event Type
- Injury
- Date Received
- August 21, 2008
- Date of Event
- July 9, 2008
- Report Date
- August 7, 2008
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- LWR
- PMA / PMN Number
- P860057/040
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED AFTER 44 MONTHS OF IMPLANTATION DUE TO ENDOCARDITIS. REPORTEDLY, THE SOURCE OF THE INFECTION IS ORAL. NO OTHER DETAILS WERE PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS | REPALCEMENT HEART VALVE | LWR | EDWARDS LIFESCIENCES | 6900PTFX | 4H1509 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Required Intervention |