FDA Adverse Event
Death
Summary report: N
CARPENTIER-EDWARDS PERIMOUNT MAGNA AORTIC BIOPROSTHESIS
MDR report key: 1113269
·
Received August 11, 2008
Report
- Report Number
- 6000002-2008-08379
- Event Type
- Death
- Date Received
- August 11, 2008
- Date of Event
- June 29, 2008
- Report Date
- August 1, 2008
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- LWR
- PMA / PMN Number
- P860057/S018
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT, A FEMALE, EXPIRED (2008) AFTER AN IMPLANT DURATION OF 0.03 MONTHS, DUE TO UNK REASONS. IT IS UNK IF THE DEATH WAS DEVICE RELATED. INFO LEARNED FROM IMPLANT PT REGISTRY. PER SURGEON'S RESPONSE, THE DEVICE WAS NOT EXPLANTED PRIOR TO DEATH AND THEREFORE IS UNAVAILABLE FOR RETURN AND EVAL. NO CAUSE OF DEATH GIVEN.
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 | R07F1241 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |