FDA Adverse Event
Death
Summary report: N
CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING
MDR report key: 1140066
·
Received August 27, 2008
Report
- Report Number
- 6000002-2008-08551
- Event Type
- Death
- Date Received
- August 27, 2008
- Date of Event
- July 11, 2008
- Report Date
- August 13, 2008
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- KRH
- PMA / PMN Number
- K926138
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, 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 AFTER IMPLANT DURATION OF ZERO DAYS, DUE TO UNKNOWN REASONS. NO FURTHER DETAILS WERE PROVIDED. INFO LEARNED FROM IMPLANT PT REGISTRY. IT IS NOW KNOWN THAT THE PT HAS EXPIRED. PT ALSO HAD ANOTHER DEVICE IMPLANTED. IT WAS ADDITIONALLY REPORTED THAT A SECOND DEVICE, MODEL#, WAS IMPLANTED. REFER TO MFR REPORT# 6000002-2008-08552.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING | ANNULOPLASTY RING | KRH | EDWARDS LIFESCIENCES | 4450 | R-08D0707 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |