FDA Adverse Event
Injury
Summary report: N
ON-X AORTIC PROSTHETIC HEART VALVE
MDR report key: 2123109
·
Received December 8, 2008
Report
- Report Number
- 1649833-2008-00011
- Event Type
- Injury
- Date Received
- December 8, 2008
- Date of Event
- October 10, 2008
- Report Date
- December 3, 2008
- Manufacturer
- ON-X LIFE TECHNOLOGIES, INC.
- Product Code
- LWQ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVAL SUMMARY - SEWING RING WAS PARTIALLY DISLODGED UPON RECEIPT BUT WAS STILL FIRMLY ATTACHED TO VALVE. REMAINDER OF VALVE WAS IN SPECIFICATION. SURGEON ACKNOWLEDGED USING TOOLS IN SURGERY IN A MANNER NOT RECOMMENDED IN THE LABELLING AND ACTUALLY CAUTIONED AGAINST.
Description of Event or Problem · 1
DURING ORIGINAL SURGERY, THE SURGEON PUSHED ON THE VALVE SEWING CUFF "REALLY HARD" WITH FORCEPS AND IN DOING SO PUSHED THE CUFF PARTIALLY OFF THE VALVE. HE REPLACED THE VALVE WITH ANOTHER AND THE PT WAS FINE AT DISCHARGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ON-X AORTIC PROSTHETIC HEART VALVE | MECHANICAL HEART VALVE | LWQ | ON-X LIFE TECHNOLOGIES, INC. | ONXA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |