FDA Adverse Event
Death
Summary report: N
CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING
MDR report key: 1315406
·
Received February 11, 2009
Report
- Report Number
- 2015691-2009-09880
- Event Type
- Death
- Date Received
- February 11, 2009
- Report Date
- February 3, 2009
- Manufacturer
- EDWARDS LIFESCIENCES, LLC.
- Product Code
- KRH
- PMA / PMN Number
- K926138
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAS EXPIRED. THE DATE OF PATIENT'S DEATH AND IMPLANT DURATION ARE UNKNOWN. IT IS UNKNOWN IF THE DEATH WAS DEVICE RELATED. 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 ANNULOPLASTY RING | ANNULOPLASTY RING | KRH | EDWARDS LIFESCIENCES, LLC. | 4450 | R-08H1660 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |