FDA Adverse Event
Injury
Summary report: N
CARPENTIER-EDWARDS PERIMOUNT AORTIC BIOPROSTHESIS
MDR report key: 1233913
·
Received November 13, 2008
Report
- Report Number
- 6000002-2008-09287
- Event Type
- Injury
- Date Received
- November 13, 2008
- Date of Event
- October 9, 2006
- Report Date
- October 29, 2008
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- LWR
- PMA / PMN Number
- P860057/S018
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED AFTER IMPLANT DURATION OF ZERO DAYS, DUE TO UNK REASONS. PATIENT ALSO HAD ANOTHER DEVICE EXPLANTED, PLEASE REFERENCE MFR#6000002-2008-09286. NO FURTHER DETAILS WERE PROVIDED. INFO LEARNED FROM IMPLANT PATIENT REGISTRY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CARPENTIER-EDWARDS PERIMOUNT AORTIC BIOPROSTHESIS | REPLACEMENT HEART VALVE | LWR | EDWARDS LIFESCIENCES | 3000 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |