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

Model Number ONXAE-25

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

Patient Problems Aortic Regurgitation (1716); Dyspnea (1816); Regurgitation (2259)

Event Date 02/28/2018

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 and implant summary cards received, onxae 25 (size 25 onx aortic heart valve with standard sewing ring with extended holder) serial number (b)(4) implanted on (b)(6) 2017, was explanted and replaced with onxaap (size 27/29 on-x ascending aortic prosthesis) serial number (b)(4) on (b)(6) 2018 for undisclosed reasons.Additional information was received via operative notes.Patient presented with shortness of breath and was hospitalized and discovered to have severe aortic regurgitation on the prosthetic valve.Cultures tested for endocarditis were all negative.

Event Description

According to the initial report and implant summary cards received, onxae 25 (size 25 onx aortic heart valve with standard sewing ring with extended holder) serial number (b)(4) implanted on (b)(6)2017 , was explanted and replaced with onxaap (size 27/29 on-x ascending aortic prosthesis) serial number (b)(4) on (b)(6)2018 for undisclosed reasons.Additional information was received via operative notes.Patient presented with shortness of breath and was hospitalized and discovered to have severe aortic regurgitation on the prosthetic valve.Cultures tested for endocarditis were all negative.

Manufacturer Narrative

The manufacturing records for the onxae-25, sn (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.A review of the available information was performed.Onxae-25 sn (b)(4) implanted in aortic position on (b)(6)2017 of 43.7 year old female with marfan's syndrome.This valve was explanted and replaced on (b)(6)2018 (243 days postimplant) with onxaap-27/29 sn (b)(4).Reoperation report indicated initial valve had "appeared virtually almost totally dehisced from the anulus circumferentially,.Barely hanging on by tissue, which is virtually just fell out when the valve was lifted out.The sutures were all attached with pledgets into the tissue and prosthetic valve indicating virtually just tearing away of the tissue with the anulus.¿ probably because the aorta sinuses appeared thin, the decision was made to replace the on-x valve with an on-x ascending aortic prosthesis (i.E.Valved conduit).The annulus was cleared to mostly live tissue and the onxaap implanted.Leads for a previously placed pacemaker were re-inserted and the patient sent to intensive care in stable but serious condition.Crossclamp time was 130 minutes.The cause of the failure was deterioration of the annular tissue such that the original sutures lost their grip and the valve worked loose.Cultures yielded negative results, which nominally rules out endocarditis, but the patient was still loaded with antibiotics as a precaution.Because of this loss of anchoring, there is no indication that the on-x valve itself failed to function as designed.But the result was severe paravalvular leakage (pvl) characterized as aortic insufficiency.The historical rate of occurrence of major pvl in rigid valve replacement is (b)(4) per patient-year [iso 5849:2005].Prosthesis perivalvular leak and reoperation are both known risks of mechanical heart valve replacement.The root cause for the explantation of the aortic on-x valve is necessitated by loss of attachment to deteriorated annular wall which resulted in severe aortic insufficiency via paravalvular leakage.The instructions for use (ifu) acknowledge the potential for perivalvular leak and explantation due to complications.The valve was performing as expected.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 PROSTHETIC HEART VALVE
• 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: 7557654
• MDR Text Key: 109690728
• Report Number: 1649833-2018-00107
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 08/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: ONXAE-25
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/02/2018
• Date Manufacturer Received: 05/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other
• Patient Age: 44 YR