FDA Adverse Event
Injury
Summary report: N
REPLACEMENT HEART VALVE
MDR report key: 1142772
·
Received August 27, 2008
Report
- Report Number
- 6000002-2008-08535
- Event Type
- Injury
- Date Received
- August 27, 2008
- Date of Event
- July 31, 2008
- Report Date
- August 4, 2008
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- LWR
- PMA / PMN Number
- P860057/S018
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED DUE TO DEHISCENCE. REPORTEDLY, THERE WAS NOTHING WRONG WITH THE VALVE. THE SURGEON INDICATED THAT THE DEVICE DEHISCED DUE TO BAD TISSUE IN A VERY SICK PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REPLACEMENT HEART VALVE | LWR | EDWARDS LIFESCIENCES | 3000 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Required Intervention |