FDA Adverse Event
Injury
Summary report: N
ON-X MITRAL PROSTHETIC HEART VALVE
MDR report key: 2123092
·
Received December 8, 2008
Report
- Report Number
- 1649833-2008-00012
- Event Type
- Injury
- Date Received
- December 8, 2008
- Date of Event
- November 4, 2008
- Report Date
- December 3, 2008
- Manufacturer
- ON-X LIFE TECHNOLOGIES, INC.
- Product Code
- LWQ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TW
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
VALVE IS BEING RETURNED FROM (B)(4). EVAL WILL BE PERFORMED ONCE REC'D.
Description of Event or Problem · 1
PT RETURNED TO HOSPITAL IN EMERGENT STATE. ON REOPERATION, A THROMBUS AROUND THE SEWING RING WAS FOUND. THE THROMBUS WAS BLOCKING THE VALVE BUT THE VALVE MECHANISM WAS FREE AND CLEAN. THE VALVE WAS REPLACED AND THE PT HAS RECOVERED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ON-X MITRAL PROSTHETIC HEART VALVE | MECHANICAL HEART VALVE | LWQ | ON-X LIFE TECHNOLOGIES, INC. | ONXMC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Required Intervention |