FDA Adverse Event
Malfunction
Summary report: N
CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS
MDR report key: 1129884
·
Received August 18, 2008
Report
- Report Number
- 6000002-2008-08433
- Event Type
- Malfunction
- Date Received
- August 18, 2008
- Date of Event
- July 31, 2008
- Report Date
- July 31, 2008
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- LWR
- PMA / PMN Number
- P860057/040
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING IMPLANTING OF THE DEVICE, WHILE SUTURING THE CUFF, THE PLASTIC PIECE THAT SCREWS INTO THE HANDLE THAT DELIVERS THE VALVE WAS VERY LOOSE CAUSING TO "SHIMMY". THE SUTURES TYING THE PLASTIC PIECE WERE LOOSE. REPORTEDLY, THE SURGEON IMPLANTED THE DEVICE; HOWEVER, HE THOUGHT THAT HE MAY HAVE BENT THE STRUCTURE (FRAME). THE PT'S TEE DID NOT REVEAL ANY PROBLEMS WITH THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS | REPACEMENT HEART VALVE | LWR | EDWARDS LIFESCIENCES | 2700TFX | R-08F1253 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |