FDA Adverse Event
Injury
Summary report: N
CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS
MDR report key: 1033800
·
Received April 24, 2008
Report
- Report Number
- 6000002-2008-06633
- Event Type
- Injury
- Date Received
- April 24, 2008
- Date of Event
- February 22, 2008
- Report Date
- March 26, 2008
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- LWR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, 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 AN IMPLANT DURATION OF 6 YEARS AND 4 MONTHS. THE REASON FOR EXPLANT IS UNKNOWN. INFORMATION LEARNED FROM IMPLANT PATIENT REGISTRY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS | REPLACEMENT HEART VALVE | LWR | EDWARDS LIFESCIENCES | 280025MM | 1F0863-A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |