FDA Adverse Event
Death
Summary report: N
CARPENTIER-EDWARDS PERIMOUNT MAGNA AORTIC BIOPROSTHESIS
MDR report key: 1082113
·
Received July 25, 2008
Report
- Report Number
- 6000002-2008-08209
- Event Type
- Death
- Date Received
- July 25, 2008
- Date of Event
- July 17, 2008
- Report Date
- July 17, 2008
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- LWR
- PMA / PMN Number
- P860057/S018
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT HAS EXPIRED. THE DATE OF PTS' DEATH AND IMPLANT DURATION ARE UNK, THEREFORE, THE AWARE DATE IS BEING USED AS THE OCCURRENCE DATE. IT IS UNK IF THE DEATH WAS DEVICE RELATED. IT WAS ADDITIONALLY REPORTED THAT A SECOND DEVICE, MODEL #4900, WAS IMPLANTED. REFER TO MFR #6000002-2008-08210. NO FURTHER DETAILS WERE PROVIDED. INFO LEARNED FROM IMPLANT PT REGISTRY.
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 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |