FDA Adverse Event
Death
Summary report: N
CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS
MDR report key: 1100507
·
Received August 5, 2008
Report
- Report Number
- 6000002-2008-08332
- Event Type
- Death
- Date Received
- August 5, 2008
- Date of Event
- November 29, 2007
- Report Date
- January 16, 2008
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- LWR
- PMA / PMN Number
- P860057/S022
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED.
Description of Event or Problem · 1
REPORTEDLY, THE PT EXPIRED IN 2007, AFTER 2 DAYS OF IMPLANT DURATION AS PER CALL FROM SPOUSE DUE TO UNK REASONS. NO FURTHER INFO HAS BEEN RECEIVED ON THIS PT AND/OR DEVICE. PLEASE REFERENCE DEVICE 6900PTFX, SIZE 27, REPLACEMENT HEART VALVE, MFR REPORT # 6000002-2008-08331, ALSO IMPLANTED IN PT. ALSO REFERENCE DEVICE 3000TFX, SIZE 21, REPLACEMENT HEART VALVE, MFR REPORT # 600002-2008-08333.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS | REPLACEMENT HEART VALVE | LWR | EDWARDS LIFESCIENCES | 6900PTFX | R-07K1965 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |