MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ONX AORTIC ANATOMIC 25; HEART-VALVE, MECHANICAL

Model Number ONXAN-25

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

Patient Problems Abscess (1690); Aortic Regurgitation (1716); Endocarditis (1834)

Event Date 01/04/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On-x valve that was implanted on (b)(6) 2017 and explanted on (b)(6) 2019.The pre-operative diagnosis was infected prosthetic aortic valve endocarditis with root abscess, severe symptomatic aortic regurgitation with dehiscence of the aortic valve and status post aortic valve and ascending hemiarch replacement.

Event Description

On-x valve that was implanted on (b)(6) 2017 and explanted on (b)(6) 2019.The pre-operative diagnosis was infected prosthetic aortic valve endocarditis with root abscess, severe symptomatic aortic regurgitation with dehiscence of the aortic valve and status post aortic valve and ascending hemiarch replacement.

Manufacturer Narrative

A review of the available information was performed.The manufacturing records for the onxan-25 sn [serial number] (b)(4) were reviewed and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record.All lots passed functional testing and met release specifications.36.05 male patient implanted with onxan-25 sn (b)(4), on (b)(6) 2017, required explant and replacement on (b)(6) 2019.Op notes indicated, pre-operative diagnosis: infected prosthetic aortic valve endocarditis with root abscess, severe symptomatic aortic regurgitation with dehiscence of the aortic valve and status post aortic valve and ascending hemiarch replacement.Initial treatment with antibiotics was not successful.A definitive cause for the endocarditis cannot be established.However, the root cause for the severe aortic regurgitation is endocarditis secondary to valve dehiscence and abscess.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 and death.No further action is required.This event does not identify additional hazards or modify the probability and severity of existing hazards.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.

• Brand Name: ONX AORTIC ANATOMIC 25
• 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: 8417755
• MDR Text Key: 138760619
• Report Number: 1649833-2019-00015
• 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
• Type of Report: Initial,Followup
• Report Date: 04/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/11/2022
• Device Model Number: ONXAN-25
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/13/2019
• Date Manufacturer Received: 02/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 37 YR