FDA Adverse Event
Death
Summary report: N
CARPENTIER-EDWARDS BIOPROSTHESIS
MDR report key: 1050209
·
Received May 23, 2008
Report
- Report Number
- 6000002-2008-07301
- Event Type
- Death
- Date Received
- May 23, 2008
- Report Date
- April 22, 2008
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- LWR
- PMA / PMN Number
- P870056
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT EXPIRED, DUE TO UNK REASON. DATE OF PT'S DEATH AND IMPLANT DURATION ARE UNK. NO FURTHER DETAILS WERE PROVIDED. INFO LEARNED FOR IMPLANT PT REGISTRY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CARPENTIER-EDWARDS BIOPROSTHESIS | REPLACEMENT HEART VALVE | LWR | EDWARDS LIFESCIENCES | 2625 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |