FDA Adverse Event
Death
Summary report: N
CARPENTIER-EDWARDS PHYSIO MITRAL ANNULOPLASTY RING WITH DURAFLO TREATMENT
MDR report key: 1233256
·
Received November 12, 2008
Report
- Report Number
- 6000002-2008-09257
- Event Type
- Death
- Date Received
- November 12, 2008
- Report Date
- October 29, 2008
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- KRH
- PMA / PMN Number
- K980487
- 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 PT'S DEATH AND IMPLANT DURATION ARE UNK. IT IS UNK IF THE DEATH WAS DEVICE RELATED. IT WAS ADDITIONALLY REPORTED THAT A SECOND DEVICE, MODEL #4900, WAS IMPLANTED. REFER TO MFR #6000002-2008-09255. 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 | ANNOLPLASTY RING | KRH | EDWARDS LIFESCIENCES | 4475 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |