FDA Adverse Event
Other
Summary report: N
CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS
MDR report key: 1040657
·
Received May 7, 2008
Report
- Report Number
- 6000002-2008-07117
- Event Type
- Other
- Date Received
- May 7, 2008
- Date of Event
- October 16, 2007
- Report Date
- November 2, 2007
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- LWR
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WAS IMPLANTED AND EXPLANTED IN 2007, DUE TO AN UNK REASON. FOLLOW UP WITH THE SURGEON INDICATED THAT THE DEVICE WAS REPLACED WITH ANOTHER MFR'S PORCINE VALVE. IT WAS ADDITIONALLY REPORTED THAT IT IS UNK IF THE DEVICE IS AVAILABLE FOR RETURN.
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 | 7B0366 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Required Intervention |