FDA Adverse Event
Death
Summary report: N
CARPENTIER-EDWARDS PHYSIO MITRAL ANNULOPLASTY RING
MDR report key: 1081700
·
Received July 22, 2008
Report
- Report Number
- 6000002-2008-08130
- Event Type
- Death
- Date Received
- July 22, 2008
- Date of Event
- December 2, 2007
- Report Date
- January 8, 2008
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- KRH
- PMA / PMN Number
- K926138
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPIRED IN LATE 2007, AFTER 5 DAYS OF IMPLANT DURATION, DUE TO UNKNOWN REASONS. IT WAS ADDITIONALLY REPORTED THAT A SECOND DEVICE, MODEL #4900, WAS EXPLANTED AT IMPLANT. REFER TO MFR #6000002-2008-08129. NO FURTHER DETAILS WERE PROVIDED. INFORMATION LEARNED FROM IMPLANT PATIENT REGISTRY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CARPENTIER-EDWARDS PHYSIO MITRAL ANNULOPLASTY RING | ANNULOPLASTY RING | KRH | EDWARDS LIFESCIENCES | 4450 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |