FDA Adverse Event
Death
Summary report: N
CARPENTIER-EDWARDS PERIMOUNT MAGNA AORTIC BIOPROSTHESIS
MDR report key: 1000169
·
Received February 18, 2008
Report
- Report Number
- 6000002-2008-06068
- Event Type
- Death
- Date Received
- February 18, 2008
- Date of Event
- September 20, 2007
- Report Date
- January 16, 2008
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- LWR
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED.
Description of Event or Problem · 1
REPORTEDLY, PT EXPIRED APPROX AFTER AN IMPLANT DURATION OF 0.63 MONTHS (IN 2007, AFTER AN IMPLANT DATE OF NINETEEN DAYS EARLIER), DUE TO UNK REASONS. UNK IF PT DEATH IS DEVICE RELATED.
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 | 07E115 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Death |