FDA Adverse Event
Death
Summary report: N
EDWARDS MC3 TRICUSPID ANNULOPLASTY SYSTEM
MDR report key: 1050201
·
Received May 23, 2008
Report
- Report Number
- 6000002-2008-07299
- Event Type
- Death
- Date Received
- May 23, 2008
- Date of Event
- March 15, 2008
- Report Date
- April 22, 2008
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- KRH
- PMA / PMN Number
- K020864
- 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 EXPIRED AFTER AN IMPLANT DURATION OF TWO MONTHS, DUE TO UNK REASONS. PT ALSO HAD A 6900P, 31MM DEVICE IMPLANTED ON THE SAME DAY IN THE MITRAL POSITION. 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 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |