FDA Adverse Event
Injury
Summary report: N
CARPENTIER-EDWARDS PERIMOUNT MAGNA AORTIC BIOPROSTHESIS
MDR report key: 1163061
·
Received September 15, 2008
Report
- Report Number
- 6000002-2008-08634
- Event Type
- Injury
- Date Received
- September 15, 2008
- Date of Event
- August 12, 2008
- Report Date
- September 3, 2008
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- LWR
- PMA / PMN Number
- P860057/S022
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, 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 APPROXIMATELY AFTER IMPLANT DURATION OF .07 MONTHS, DUE TO PERIVALVULAR LEAK. NO FURTHER DETAILS WERE PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CARPENTIER-EDWARDS PERIMOUNT MAGNA AORTIC BIOPROSTHESIS | REPLACEMENT HEART VALVE | LWR | EDWARDS LIFESCIENCES | 3000TFX | R08F1115 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |