FDA Adverse Event
Injury
Summary report: N
CARPENTIER-EDWARDS PERIMOUNT MAGNA AORTIC BIOPROSTHESIS
MDR report key: 1040577
·
Received May 9, 2008
Report
- Report Number
- 6000002-2008-07152
- Event Type
- Injury
- Date Received
- May 9, 2008
- Date of Event
- March 19, 2008
- Report Date
- April 11, 2008
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- LWR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED.
Description of Event or Problem · 1
REPORTEDLY THE DEVICE WAS IMPLANTED AND EXPLANTED AFTER AN IMPLANT DURATION OF ZERO DAYS, DUE TO UNKNOWN REASONS. INFO LEARNED FROM IMPLANT PT REGISTRY. NO FURTHER INFO WAS REC'D.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CARPENTIER-EDWARDS PERIMOUNT MAGNA AORTIC BIOPROSTHESIS | REPLACEMENT HEART VALVE | LWR | EDWARDS LIFESCIENCES | 3000 | R-07M2367 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |