FDA Adverse Event
Other
Summary report: N
CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL AORTIC BIOPROSTHESIS
MDR report key: 1014104
·
Received March 12, 2008
Report
- Report Number
- 6000002-2008-06197
- Event Type
- Other
- Date Received
- March 12, 2008
- Date of Event
- January 17, 2008
- Report Date
- February 13, 2008
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- LWR
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS NOT RETURNED FOR EVALUATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE VALVE WAS EXPLANTED AFTER 54 MONTHS OF IMPLANTATION. THE REASON FOR THE EXPLANT WAS NOT REPORTED, AS NO OTHER DETAILS WERE PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL AORTIC BIOPROSTHESIS | PERICARDIAL AORTIC BIOPROSTHESIS | LWR | EDWARDS LIFESCIENCES | 300025MM | JH1909 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Required Intervention |