FDA Adverse Event
Death
Summary report: N
CARPENTIER-EDWARDS PHYSIO MITRAL ANNULOPLASTY RING WITH DURAFLO TREATMENT
MDR report key: 1163046
·
Received September 12, 2008
Report
- Report Number
- 6000002-2008-08631
- Event Type
- Death
- Date Received
- September 12, 2008
- Date of Event
- February 29, 2008
- Report Date
- August 15, 2008
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- KRH
- PMA / PMN Number
- K980487
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- 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 IN 2008, AFTER IMPLANT DURATION OF 8 DAYS (.27 MONTHS), DUE TO RENAL FAILURE AND CARDIAC ARREST. IT IS UNK IF THE DEATH WAS DEVICE RELATED. 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 PHYSIO MITRAL ANNULOPLASTY RING WITH DURAFLO TREATMENT | ANNULOPLASTY RING | KRH | EDWARDS LIFESCIENCES | 4475 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |