MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC ON-X AORTIC HEART VALVE WITH CONFORM-X SEWING RINGA AND EXTENDED HOLDER - 25MM; MECHANICAL HEART VALVE

Model Number	ONXACE-25
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/22/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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.
Event or Problem Description
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.".

• Brand Name: ON-X AORTIC HEART VALVE WITH CONFORM-X SEWING RINGA AND EXTENDED HOLDER - 25MM
• Common Device Name: MECHANICAL HEART VALVE
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES, INC; 1300 e. anderson ln.; bldg b; austin TX 78752
• MDR Report Key: 5995392
• Report Number: 1649833-2016-00032
• Device Sequence Number: 570569
• Product Code: LWQ
• UDI-Device Identifier: 00851788001471
• UDI-Public: 00851788001471
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P000037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Model Number: ONXACE-25
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2016
• Initial Report FDA Received Date: 10/03/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 45 YR