FDA Adverse Event
Injury
Summary report: N
CARPENTIER-EDWARDS CLASSIC MITRAL ANNULOPLASTY RING
MDR report key: 1242206
·
Received November 18, 2008
Report
- Report Number
- 6000002-2008-09294
- Event Type
- Injury
- Date Received
- November 18, 2008
- Date of Event
- October 16, 2008
- Report Date
- October 30, 2008
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- KRH
- PMA / PMN Number
- K912554
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ME, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED APPROX AFTER IMPLANT DURATION OF 122 MOS, DUE TO RECURRENT MITRAL STENOSIS AND MITRAL INSUFFICIENCY. NO FURTHER DETAILS WERE PROVIDED. INFO LEARNED FROM OPERATIVE REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CARPENTIER-EDWARDS CLASSIC MITRAL ANNULOPLASTY RING | ANNULOPLASTY RING | KRH | EDWARDS LIFESCIENCES | 4400 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Required Intervention |