FDA Adverse Event
Injury
Summary report: N
ON-X MITRAL PROSTHETIC HEART VALVE
MDR report key: 2123087
·
Received December 8, 2008
Report
- Report Number
- 1649833-2008-00013
- Event Type
- Injury
- Date Received
- December 8, 2008
- Date of Event
- October 17, 2008
- Report Date
- December 3, 2008
- Manufacturer
- ON-X LIFE TECHNOLOGIES, INC.
- Product Code
- LWQ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
VALVE IS BEING RETURNED FROM (B)(6). EVAL WILL BE PERFORMED ONCE REC'D.
Description of Event or Problem · 1
PT DEVELOPED PROSTHETIC DYSFUNCTION DUE TO THROMBUS. THE PT WAS REOPERATED AND THE VALVE REPLACED. THE PT 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. | ONXM |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Required Intervention |