FDA Adverse Event
Injury
Summary report: N
ON-X AORTIC HEART VALVE WITH CONFORM-X SEWING RINGA AND EXTENDED HOLDER - 25MM
MDR report key: 5995392
·
Received October 3, 2016
Report
- Report Number
- 1649833-2016-00032
- Event Type
- Injury
- Date Received
- October 3, 2016
- Date of Event
- June 22, 2016
- Report Date
- October 3, 2016
- Manufacturer
- ON-X LIFE TECHNOLOGIES, INC
- Product Code
- LWQ
- UDI-DI
- 00851788001471
- PMA / PMN Number
- P000037
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE ON-X 614 HEART VALVE DESIGN FMEA 940816 01 REV S THOROUGHLY IDENTIFIES THE PROCESS AND PRODUCT HAZARDS FOR APPROVED INDICATIONS. EACH INDIVIDUAL HAZARD IS MITIGATED AND REDUCED AS LOW AS POSSIBLE BY DESIGN AND PROCESS. POST PRODUCTION RESIDUAL RISK IS COMMUNICATED IN THE PRODUCT'S LABELING AND INSTRUCTION FOR USE (IFU). REOPERATION IS A KNOWN COMPLICATION OF PROSTHETIC VALVE IMPLANTATION AND IS LISTED IN THE IFU. WITHOUT RETURN OF THE VALVE, A SPECIFIC RISK CANNOT BE IDENTIFIED.
Description of Event or Problem · 1
IMPLANT RECOVERY CARD RECEIVED INDICATE THAT PATIENT RECEIVED ONXACE-25 ON (B)(6) 2015 WHICH REQUIRED INTERVENTION/EXPLANT ON (B)(6) 2016 AND REPLACEMENT WITH AN ONXAAP-25 INDICATED FOR "ENLARGED ANEURYSM OF ASCENDING AORTA."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 645725 | ON-X AORTIC HEART VALVE WITH CONFORM-X SEWING RINGA AND EXTENDED HOLDER - 25MM | MECHANICAL HEART VALVE | LWQ | ON-X LIFE TECHNOLOGIES, INC | ONXACE-25 | 00851788001471 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Hospitalization| O |