FDA Adverse Event
Death
Summary report: N
EDWARDS MC3 TRICUSPID ANNULOPLASTY SYSTEM
MDR report key: 1131763
·
Received August 21, 2008
Report
- Report Number
- 6000002-2008-08486
- Event Type
- Death
- Date Received
- August 21, 2008
- Date of Event
- July 29, 2008
- Report Date
- August 12, 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. PLEASE REFER TO MEDWATCH NUMBER 6000002-2008-08485.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPIRED IN 2008, AFTER AN IMPLANT DURATION OF 19 DAYS DUE TO UNKNOWN REASONS. FOLLOW UP WITH THE SURGEON'S OFFICE DID NOT INDICATE THE REASON FOR THE PATIENT'S DEMISE. REPORTEDLY, THE DEVICE WAS NOT EXPLANTED. AT THE TIME OF THE PATIENT'S DEMISE THERE WAS ANOTHER DEVICE (VALVE) IMPLANT LOCATED IN THE AORTIC POSITION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EDWARDS MC3 TRICUSPID ANNULOPLASTY SYSTEM | ANNULOPLASTY | KRH | EDWARDS LIFESCIENCES | 4900T | R-08F1331 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Death |