MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ON-X PROSTHETIC AORTIC VALVE WITH CONFORM-X SEWING RING AND EXTENDED HOLDER; HEART-VALVE, MECHANICAL

Model Number	ONXACE-21
Medical Device Problem Codes	Perivalvular Leak (1457); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Regurgitation (2259)
Date of Event	06/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This investigation is currently ongoing.Any additional information will be provided in the follow-up report.
Event or Problem Description
According to initial reports, the surgeon implanted an onxace-21 serial number (b)(4) in a redo avr case.On cardiac echo when the patient came off bypass a leak was noted through the leaflets.Surgeon explanted it and replace it with another identical onxace-21.Pertinent co-morbidities - heavily calcified annulus.
Additional Manufacturer Narrative
A review of the available information was performed.A copy of the intra-operative echos were provided and reviewed.It was noted that there was significant anterior leakage and that the presence of anterior paravalvular leak (pvl) could not be confirmed or denied.It was confirmed that the leak was not due to on-x valve signature washing jets.A definitive determination for the type or cause of the leak cannot be made.Regardless, a leak of some type was present and explant of the valve was required and reimplantation was performed.The instructions for use for the on-x valve acknowledge paravalvular leak as a potential complication following prosthetic valve replacement, which may lead to reoperation as well as explanation [ifu].Historically, pvl occurs at a rate 1.2% per patient-year for all pvls, while major pvl occurs at a rate of 0.6% per patient-year for rigid heart valve substitutes [iso 5840:2005(e)].The manufacturing records for the packaging of valve onxae-27/29 serial number (b)(6) were reviewed and it was confirmed that all records were controlled, available for review, and met all specifications.All lots passed functional testing and met release specifications.During the investigation no non-conformances or deviations were noted.The valve was returned for evaluation.Valve was received as an intact valve assembly.Prior to decontamination visual examination of valve shows leaflet and housing intact.No tissue or thrombus evident.Leaflets fully open & close without bind.After decontamination, no evidence of visual anomalies in pivot location or on leaflets as assembled.Valve was disassembled & components were dimensionally inspected.The valve housing & leaflets were reassembled, functionally, & visually inspected.Valve passed dimensional, functional, & visual inspections.No deficiencies noted regarding this valve.This event does not identify additional hazards or modify the probability and severity of existing hazards.No further action is required at this time.Should additional information become available, it will be evaluated and the complaint will be reopened.This report is being submitted as required by federal regulations and does not constitute an admission that the device caused or contributed to the reported event.Furthermore, this report reflects the event as alleged by the complainant and does not imply that the information reported to cryolife is accurate or has been confirmed by cryolife.

• Brand Name: ON-X PROSTHETIC AORTIC VALVE WITH CONFORM-X SEWING RING AND EXTENDED HOLDER
• Common Device Name: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES, INC.; 1300 e. anderson ln., bldg. b; austin TX 78752
• MDR Report Key: 8790283
• Report Number: 1649833-2019-00046
• Device Sequence Number: 2666301
• Product Code: LWQ
• UDI-Device Identifier: 00851788001457
• UDI-Public: 00851788001457
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P000037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2019

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: No Information
• Device Expiration Date: 10/31/2024
• Device Model Number: ONXACE-21
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2019
• Distributor Facility Aware Date: 06/17/2019
• Initial Date Received by Manufacturer: 06/17/2019
• Supplement Date Received by Manufacturer: 06/17/2019
• Initial Report FDA Received Date: 07/15/2019
• Supplement Report FDA Received Date: 09/17/2019
• 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: Life Threatening; Required Intervention
• Patient Age: 24 YR