MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ONX MITRAL STANDARD 27/29; HEART-VALVE, MECHANICAL

Model Number	ONXM-27/29
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Endocarditis (1834); Fistula (1862)
Date of Event	09/06/2018
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 the initial report, patient received onxm 27/29 sn (b)(4) on (b)(6) 2016 with an explant on (b)(6) 2018.According to operative notes, patient experienced endocarditis, development of a fistulous tract and aortic-mitral curtain and into the right ventricle.
Additional Manufacturer Narrative
A review of the available information was performed.The manufacturing records for the onxm-27/29 sn [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.Onxm-27/29 sn (b)(6) 1 and onxaap-27/29 were reported as implanted in the mitral and aortic positions, respectively, in a double-valve procedure for a 23 year old male on (b)(6) 2016.On (b)(6) 2018 (2 years 60 days postop), the reoperative report shows that both valves were explanted and replaced.In addition to the aortic and mitral valve replacements, extensive reconstruction of the heart outflow tracts, both left and right, were implemented using bovine pericardial patch material.Furthermore, a 27mm [brand] valve was used to replace the native pulmonic valve and pacer wire leads removed.The explanted valves were not provided to the manufacturer for examination.The operative notes indicate that the underlying cause necessitating the valve replacements is "endocarditis [of unidentified origin], development of a fistulous tract and aortic-mitral curtain into the right ventricle." with reference to the mitral on-x valve explantation and subsequent replacement, endocarditis is the underlying cause necessitating the reoperation.The origin of the infection is not identified, but because the on-x valve undergoes a validated terminal sterilization step during processing the endocarditis is likely not related to the on-x product.The instructions for use for the on-x valve lists endocarditis as a possible complication of mechanical heart valve replacement and includes the possibility of reoperation and/or explantation.Endocarditis is the primary contributor leading to the need for reoperation, explantation, and replacement of the previous mitral prosthetic heart valve.There is no indication that the on-x valve had any relationship to the complications necessitating its removal and replacement.No further action is required.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.
Event or Problem Description
According to the initial report, patient received onxm 27/29 sn (b)(6) 1 on (b)(6) 2016 with an explant on (b)(6) 2018.According to operative notes, patient experienced endocarditis, development of a fistulous tract and aortic-mitral curtain and into the right ventricle.

• Brand Name: ONX MITRAL STANDARD 27/29
• 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: 7953456
• Report Number: 1649833-2018-00154
• Device Sequence Number: 16250239
• Product Code: LWQ
• UDI-Device Identifier: 00851788001280
• UDI-Public: 851788001280
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: P000037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2018

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: Health Professional
• Device Expiration Date: 03/01/2022
• Device Model Number: ONXM-27/29
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/19/2018
• Initial Date Received by Manufacturer: 09/19/2018
• Supplement Date Received by Manufacturer: 09/19/2018
• Initial Report FDA Received Date: 10/10/2018
• Supplement Report FDA Received Date: 11/13/2018
• 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: 25 YR