FDA Adverse Event
Injury
Summary report: N
ON-X PROSTHETIC HEART VALVE
MDR report key: 2123089
·
Received August 28, 2008
Report
- Report Number
- 1649833-2008-00005
- Event Type
- Injury
- Date Received
- August 28, 2008
- Date of Event
- July 18, 2008
- Report Date
- August 19, 2008
- Manufacturer
- ON-X LIFE TECHNOLOGIES, INC.
- Product Code
- LWQ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SF
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
VALVE WILL BE RETURNED ONCE RELEASED BY THE LOCAL HOSPITAL. EVAL TO BE DONE ONCE REC'D.
Description of Event or Problem · 1
PT IN RESPIRATORY FAILURE UNDERWENT EMERGENCY RE-DO MITRAL VALVE REPLACEMENT DUE TO A THROMBOSED VALVE. ON REOPERATION THROMBUS WAS FOUND BLOCKING ONE LEAFLET COMPLETELY AND RESTRICTING THE MOTION OF THE OTHER. PT RECOVERED. INR WAS IN RANGE AT SURGERY BUT PT HAD A HISTORY OF NON-COMPLIANCE WITH MEDICATIONS. CLOT CONFIRMED BY LOCAL UNINVOLVED SURGEON.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ON-X PROSTHETIC HEART VALVE | MECHANICAL HEART VALVE | LWQ | ON-X LIFE TECHNOLOGIES, INC. | ONXM |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 22 YR | Life Threatening| R |