FDA Adverse Event
Death
Summary report: N
CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING WITH DURAFLO TREATMENT
MDR report key: 1106407
·
Received August 7, 2008
Report
- Report Number
- 6000002-2008-08355
- Event Type
- Death
- Date Received
- August 7, 2008
- Date of Event
- December 10, 2007
- Report Date
- July 24, 2008
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- KRH
- PMA / PMN Number
- K980487
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT HAS EXPIRED AFTER AN IMPLANT DURATION OF 1 MO, DUE TO UNK REASONS. IT IS UNK IF 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 ANNULOPLASTY RING WITH DURAFLO TREATMENT | ANNULOPLASTY RING | KRH | EDWARDS LIFESCIENCES | 4475 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |