FDA Adverse Event
Injury
Summary report: N
CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS
MDR report key: 1211484
·
Received October 21, 2008
Report
- Report Number
- 6000002-2008-09011
- Event Type
- Injury
- Date Received
- October 21, 2008
- Date of Event
- September 26, 2008
- Report Date
- October 8, 2008
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- LWR
- PMA / PMN Number
- P860057/S016
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED.
Description of Event or Problem · 1
REPORTEDLY, THE VALVE WAS EXPLANTED DUE TO SEVERE CENTRAL LEAKAGE. IMPLANT/EXPLANT DATE UNKNOWN. VALVE WAS REPLACED BY SAME MODEL AND SIZE DEVICE. PATIENT IS REPORTED TO BE DOING "OK".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS | REPLACEMENT HEART VALVE | LWR | EDWARDS LIFESCIENCES | 6900P | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Hospitalization| R |