FDA Adverse Event
Death
Summary report: N
EDWARDS MC3 TRICUSPID ANNULOPLASTY SYSTEM
MDR report key: 1201373
·
Received October 16, 2008
Report
- Report Number
- 6000002-2008-08935
- Event Type
- Death
- Date Received
- October 16, 2008
- Date of Event
- September 14, 2008
- Report Date
- October 7, 2008
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- KRH
- PMA / PMN Number
- K020864
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- 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 APPROXIMATELY AFTER IMPLANT DURATION OF 0.17 MONTHS DUE TO UNKNOWN REASONS. IT IS UNKNOWN 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 | EDWARDS MC3 TRICUSPID ANNULOPLASTY SYSTEM | ANNULOPLASTY RING | KRH | EDWARDS LIFESCIENCES | 4900 | R-08G1418 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |