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

Model Number ONXAAP-27/29

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Endocarditis (1834); Fistula (1862)

Event Date 09/06/2018

Event Type  Injury  

Manufacturer Narrative

This investigation is currently ongoing.Any additional information will be provided in the follow-up report.

Event Description

According to the initial report, patient received onxaap-27/29 sn (b)(4) on (b)(6) 2016 with an explant on (b)(6) 2018.Operative notes were received, the preoperative diagnosis was endocarditis, development of a fistulous tract and aortic-mitral curtain and into the right ventricle.

Manufacturer Narrative

A review of the available information was provided.The manufacturing records for the onxaap-27/29 sn [serial number] (b)(4) 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 specification.Onxm-27/29 and onxaap-27/29 sn (b)(4) 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 ascending aortic 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 aap valve list endocarditis and graft infection as possible complications of mechanical heart valve replacement and includes the possibility of reoperation and/or explantation [ifu].Endocarditis is the primary contributor leading to the need for reoperation, explantation, and replacement of the previous ascending aortic 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 Description

According to the initial report, patient received onxaap-27/29 sn (b)(4) on (b)(6)2016 with an explant on (b)(6)2018.Operative notes were received, the preoperative diagnosis was endocarditis, development of a fistulous tract and aortic-mitral curtain and into the right ventricle.

• Brand Name: ONX ASCENDING AORTIC 27/29
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES, INC.; 1300 e. anderson ln., bldg. b; austin TX 78752
• MDR Report Key: 7975150
• MDR Text Key: 124080341
• Report Number: 1649833-2018-00158
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• PMA/PMN Number: P000037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 11/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2020
• Device Model Number: ONXAAP-27/29
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/19/2018
• Date Manufacturer Received: 09/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 25 YR