FDA Adverse Event
Injury
Summary report: N
CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS
MDR report key: 1202954
·
Received October 16, 2008
Report
- Report Number
- 6000002-2008-08934
- Event Type
- Injury
- Date Received
- October 16, 2008
- Date of Event
- October 2, 2008
- Report Date
- October 2, 2008
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- LWR
- PMA / PMN Number
- P860057/S016
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED.
Description of Event or Problem · 1
THE DEVICE WAS IMPLANTED DUE TO MITRAL REGURGITATION IN 2008. AFTER THE IMPLANT, REGURGITATION WAS OBSERVED THROUGH THE COMMISSURE POST TO THE CENTRAL AREA. THE DEVICE WAS EXPLANTED AND A 6900P-27MM VALVE WAS IMPLANTED AS A REPLACEMENT. CUSTOMER COMMENTED THAT ONE OF THE LEAFLETS LOOKED SMALLER. CUSTOMER REQUESTED TO INVESTIGATE THE LEAFLET SIZE AND THE REGURGITATION. DEVICE TO BE SENT TO R&D FOR FURTHER INVESTIGATION. CUSTOMER HAS REQUIRED A LEAK TEST OF THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS | REPLACEMENT HEART VALVE | LWR | EDWARDS LIFESCIENCES | 6900P | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Hospitalization| R |