FDA Adverse Event
Death
Summary report: N
CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING WITH DURAFLO TREATMENT
MDR report key: 1707840
·
Received June 2, 2010
Report
- Report Number
- 2015691-2010-13469
- Event Type
- Death
- Date Received
- June 2, 2010
- Report Date
- May 3, 2010
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- KRH
- PMA / PMN Number
- K980487
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED. THIS EVENT WAS DETERMINED TO BE REPORTABLE PER EDWARDS LIFESCIENCES PROCEDURES. THE INFORMATION WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY. THE PATIENT ALSO HAD ANOTHER DEVICE IMPLANTED;(B) (4). TWO REQUESTS WERE MADE (VIA E-MAIL) FOR THE DEVICE, OPERATIVE REPORT, AND ADDITIONAL INFORMATION (ON 05/04/2010 AND 05/11/2010); HOWEVER, NO ADDITIONAL INFORMATION WAS RECEIVED. THE DEVICE HISTORY RECORD (DHR) REVIEW HAS BEEN COMPLETED, AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAS EXPIRED. NO FURTHER DETAILS WERE PROVIDED. THE DATE OF PATIENT'S DEATH AND IMPLANT DURATION REMAIN UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING WITH DURAFLO TREATMENT | ANNULOPLASTY RING | KRH | EDWARDS LIFESCIENCES | 4475 | R-08L2470 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Death |