FDA Adverse Event
Death
Summary report: N
EDWARDS MC3 TRICUSPID ANNULOPLASTY SYSTEM
MDR report key: 1140043
·
Received August 26, 2008
Report
- Report Number
- 6000002-2008-08542
- Event Type
- Death
- Date Received
- August 26, 2008
- Date of Event
- August 15, 2008
- Report Date
- August 15, 2008
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- KRH
- PMA / PMN Number
- K020864
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, 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 DUE TO CEREBROVASCULAR ACCIDENT. THE DATE OF PT'S DEATH AND IMPLANT DURATION ARE UNK, THEREFORE, THE AWARE DATE IS BEING USED AS THE OCCURRENCE DATE. IT IS UNK IF THE DEATH WAS DEVICE RELATED. NO FURTHER DETAILS WERE PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EDWARDS MC3 TRICUSPID ANNULOPLASTY SYSTEM | ANNULOPLASTY RING | KRH | EDWARDS LIFESCIENCES | 4900 | R08E1006 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |