FDA Adverse Event
Death
Summary report: N
CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL AORTIC BIOPROSTHESIS
MDR report key: 1727328
·
Received June 17, 2010
Report
- Report Number
- 2015691-2010-13585
- Event Type
- Death
- Date Received
- June 17, 2010
- Report Date
- May 20, 2010
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- DYE
- PMA / PMN Number
- P860057/S042
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- 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. TWO REQUESTS WERE MADE TO THE HEALTH-CARE PROVIDER (VIA FAX) FOR THE DEVICE, OPERATIVE REPORT, AND ADDITIONAL INFORMATION (ON 05/21/2010 AND 05/28/2010); HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED AND NO DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS 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. THE DATE OF PATIENT'S DEATH AND IMPLANT DURATION ARE UNKNOWN. IT IS UNKNOWN IF THE DEATH WAS DEVICE RELATED. NO FURTHER DETAILS WERE PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL AORTIC BIOPROSTHESIS | REPLACEMENT HEART VALVE | DYE | EDWARDS LIFESCIENCES | 3300TFX | R-09F1458 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |