FDA Adverse Event
Summary report: N
CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING
MDR report key: 1051806
·
Received May 21, 2008
Report
- Report Number
- 6000002-2008-07268
- Date Received
- May 21, 2008
- Date of Event
- October 6, 2007
- Report Date
- January 3, 2008
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- KRH
- PMA / PMN Number
- K926138
- 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 DEVICE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 47 MONTHS. THE HEALTH CARE PROVIDER INDICATED THAT THE DEVICE WAS EXPLANTED BECAUSE IT WAS AT THE END OF ITS LIFE. IT WAS ADDITIONALLY REPORTED THAT THE PT UNDERWENT AN ORTHOTOPIC HEART TRANSPLANT IN 2007. THE STATUS OF THE EXPLANTED DEVICE WAS NOT PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING | ANNULOPLASTY RING | KRH | EDWARDS LIFESCIENCES | 4450 | 3G1386 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Required Intervention |