FDA Adverse Event
Death
Summary report: N
CARPENTIER-EDWARDS S.A.V. PORCINE AORTIC BIOPROSTHESIS
MDR report key: 1669000
·
Received April 28, 2010
Report
- Report Number
- 2015691-2010-13225
- Event Type
- Death
- Date Received
- April 28, 2010
- Date of Event
- May 3, 2007
- Report Date
- April 8, 2010
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- DYE
- PMA / PMN Number
- P010041
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CUSTOMER LETTER NOT REQUIRED. THIS WAS DETERMINED REPORTABLE PER EDWARDS LIFESCIENCES PROCEDURES. DEVICE WILL NOT BE RETURNED DUE TO THE INFECTION. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE DHR REVIEW WAS COMPLETED. THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE.
Description of Event or Problem · 1
REPORTEDLY, PATIENT DEATH DUE TO CARDIAC FAILURE AFTER AN IMPLANT DURATION 34.7 MONTHS. PER THE CER AND AE REPORT: DEATH DUE TO CARDIAC FAILURE. AUTOPSY WAS PERFORMED AND INFECTIVE ENDOCARDITIS WAS DIAGNOSED POST MORTEM. PATIENT BEING INVESTIGATED FOR GASTROINTESTINAL PROBLEMS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CARPENTIER-EDWARDS S.A.V. PORCINE AORTIC BIOPROSTHESIS | REPLACEMENT HEART VALVE | DYE | EDWARDS LIFESCIENCES | 2650 | 04F002 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Death |