FDA Adverse Event
Death
Summary report: N
CARPENTIER-EDWARDS CLASSIC ANNULOPLASTY RING
MDR report key: 1040569
·
Received May 9, 2008
Report
- Report Number
- 6000002-2008-07147
- Event Type
- Death
- Date Received
- May 9, 2008
- Date of Event
- February 18, 2008
- Report Date
- April 10, 2008
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- KRH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPIRED AFTER AN IMPLANT DURATION OF ONE MONTH, DUE TO UNKNOWN REASONS. IT IS UNKNOWN IF THE DEVICE WAS EXPLANTED AND IF THE PATIENT'S DEATH WAS DEVICE RELATED. INFORMATION LEARNED FROM IMPLANT PATIENT REGISTRY. NO FURTHER INFORMATION WAS RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CARPENTIER-EDWARDS CLASSIC ANNULOPLASTY RING | ANNULOPLASTY RING | KRH | EDWARDS LIFESCIENCES | 4400 | R-07L2152 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |