FDA Adverse Event
Injury
Summary report: N
UNK
MDR report key: 1301422
·
Received January 26, 2009
Report
- Report Number
- 6000002-2009-09724
- Event Type
- Injury
- Date Received
- January 26, 2009
- Date of Event
- December 7, 2008
- Report Date
- December 23, 2008
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- LWR
- PMA / PMN Number
- UNK
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED.
Description of Event or Problem · 1
REPORTEDLY, THE EXPLANTED VALVE MODEL AND SIZE IS UNK. IMPLANT DURATION IS AT LEAST 66 MONTHS. INITIAL SURGERY WAS PERFORMED IN AKH VIENNA/AUSTRIA IN MAY 2003. INDICATION FOR REDO: HIGHLY STENOTIC PROSTHETIC VALVE. LEAFLETS WERE HEAVILY CALCIFIED AT BASE AND LEFT CORONARY LEAFLET COMPLETELY STIFF THUS CREATING A HIGH DEGREE OF VALVE STENOSIS. NO FURTHER INFORMATION AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNK | REPLACEMENT HEART VALVE | LWR | EDWARDS LIFESCIENCES | HVTUNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Hospitalization| R | NO |