FDA Adverse Event
Death
Summary report: N
CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS
MDR report key: 1702626
·
Received June 1, 2010
Report
- Report Number
- 2015691-2010-13454
- Event Type
- Death
- Date Received
- June 1, 2010
- Date of Event
- April 22, 2010
- Report Date
- April 30, 2010
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- DYE
- PMA / PMN Number
- P860057/S016
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS EVENT WAS DETERMINED TO BE REPORTABLE PER EDWARDS LIFESCIENCES PROCEDURES. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED, AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE. NO CUSTOMER LETTER WAS REQUESTED. NO PRODUCT RETURN.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT DIED DUE TO UNKNOWN REASONS. NO FURTHER DETAILS WERE PROVIDED. THE DEVICE WILL BE NOT RETURNED (IT IS UNKNOWN IF THE DEVICE WAS REMOVED PRIOR TO THE PATIENT¿S DEATH). ALSO, IT IS UNKNOWN IF THERE WAS AN AUTOPSY. INFORMATION WAS LEARNED THROUGH (B) (4) IMPLANT PATIENT REGISTRY. REPORT ONLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS | REPLACEMENT HEART VALVE | DYE | EDWARDS LIFESCIENCES | 6900P | 09L306 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Death |