FDA Adverse Event
Injury
Summary report: N
CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS
MDR report key: 1081631
·
Received July 22, 2008
Report
- Report Number
- 6000002-2008-08145
- Event Type
- Injury
- Date Received
- July 22, 2008
- Date of Event
- July 15, 2008
- Report Date
- July 16, 2008
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- LWR
- PMA / PMN Number
- P860057S016
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE SURGEON WENT TO REMOVE THE PATIENT FROM BYPASS, BRIGHT RED BLOOD WAS OBSERVED IN THE PATIENT'S CHEST. THE SURGEON FOUND THAT THE DEVICE STRUT HAD PUNCTURED THE PATIENT'S HEART. THE DEVICE WAS REMOVED AND REPLACED WITH A MECHANICAL VALVE.
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 | 64 YR | Required Intervention |