MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ONX AORTIC CONFORM EXT 21; HEART-VALVE, MECHANICAL

Model Number ONXACE-21

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

Patient Problems Dehydration (1807); Regurgitation (2259)

Event Date 05/20/2019

Event Type  Injury  

Manufacturer Narrative

This investigation is currently ongoing.Any additional information will be provided in the follow-up report.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, "pt.(number) in the on-x aortic post approval study, patient admitted with pre syncope, weakness, dizziness, resolved with iv fluids, echo showed ef of 65% with moderately elevated aortic prosthetic gradients with mild to moderate paravalvular regurgitation, which is new compared to previous echo, pre syncope, inr 2.8 at time of event".This event is associated with onxace-21 sn (b)(4).According to the adjudicator, "patient has had an admission for presyncopal complaints which are major since requiring hospitalization, but are not valve-related.The question i would raise is whether one reports the new paravalvular regurgitation that was noted in the description of the complication.It is described as mild to moderate and as not being present at the prior echo.This is an incidental finding, which is not related to the complaint and as such is asymptomatic.I do not know if this should even be reported, and no one would do anything different other than to follow it with periodic echos.".

Manufacturer Narrative

The manufacturing records for the onxace-21 sn (b)(6) 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.An onxace-21 sn (b)(6) was implanted in a 64 year old male patient in the aortic position on (b)(6) 2019.On (b)(6) 2019 (two months post-implant), the patient was admitted for pre-syncope, weakness, and dizziness which was resolved with iv fluids.An echocardiogram showed elevated aortic prosthetic gradients and mild to moderate paravalvular leak (pvl) not previously noted on echo.The clinical study adjudicator considers the pvl an incidental observation, unrelated to the symptoms which he further characterizes as not valve related.The patient¿s inr is reported as 2.8, which is out-of-range for this study participant (inr 1.5-2.0).The patient¿s pre-syncope was relieved by iv fluids, suggesting that the onset is likely related to dehydration.There is no evidence to suggest that the on-x valve in any way contributed to the symptoms.The observation on echo of mild to moderate pvl is incidental and also unrelated to the complication reported.Probable cause of pre-syncope is dehydration.There is no evidence to suggest that the on-x valve had any relationship to the reported adverse event.All lots passed functional testing and met release specifications.This event does not identify additional hazards or modify the probability and severity of existing hazards.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 CONFORM EXT 21
• 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: 9213468
• MDR Text Key: 163175989
• Report Number: 1649833-2019-00061
• 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: study
• Type of Report: Initial,Followup
• Report Date: 01/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ONXACE-21
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 10/01/2019
• Date Manufacturer Received: 10/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 63 YR