MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ON-X PROSTHETIC AORTIC VALVE WITH CONFORM-X SEWING RING AND EXTENDED HOLDER- 21; HEART-VALVE, MECHANICAL

Model Number ONXACE-21

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

Patient Problem Aortic Regurgitation (1716)

Event Date 04/29/2020

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 experienced "severe paravalvular aortic regurgitation requiring redo avr [aortic valve replacement] and cabg.".

Manufacturer Narrative

According to the initial report received, the patient experienced "severe paravalvular aortic regurgitation requiring redo avr [aortic valve replacement] and cabg [coronary artery bypass grafting]." multiple requests for additional information were unsuccessful.This complaint is in reference to onxace-21, serial number (sn) (b)(6).The manufacturing records for 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.During the investigation no non-conformances or deviations were noted.All leaflets get tested as part of the standard manufacturing process per le10582.Onxace-21, sn (b)(6) was implanted in the aortic position of a (b)(6) male on (b)(6) 2019.The patient is a study participant in the on-x aortic prosthetic heart valve low dose warfarin post approval study.A complication event dated (b)(6) 2020 (385-days post-implant) was entered into the study database.The study¿s adjudication committee have determined this to be a valve-related paravalvular leak.The data entered in the study database noted the patient¿s cardiac history includes regurgitation and endocarditis.It is also noted that the patient experienced ¿severe paravalvular aortic regurgitation requiring redo aortic valve replacement and cabg.¿ ultimately, the onxace-21, sn (b)(6) was explanted and replaced with another onxace-21 valve.There was no other information received from the site as to the underlying cause of the paravalvular leak which led to the decision to explant the valve.The data entered into the study database indicates the outcome as fully resolved following the re-operation.However, we do not have any information explaining the cause of the paravalvular leak.Consequently, while the adjudication committee ruled this as valve-related, we do not have any information to indicate what, if any, contribution the valve had to the paravalvular leak itself.The instructions for use for the on-x valve acknowledge paravalvular leak as a potential complication following prosthetic valve replacement, which may lead to reoperation as well as explantation [ifu].Historically, paravalvular leak (pvl) occurs at a rate of (b)(4) per patient-year for all pvls, while major pvl occurs at a rate of (b)(4) per patient-year for rigid heart substitutes [iso 5840:2005(e)].There is no information to suggest the reason for the paravalvular leak and therefore no information to explain what, if any, contribution the valve had to the decision to explant it.The on-x heart valve risk management file thoroughly identifies the process and product hazards for approved indications.The failure modes are identified in the on-x heart valve design fmea in the "potential failure mode" as "perivalvular leak.¿ each individual risk is mitigated and reduced as far as possible by design and process.Post production residual risk is communicated in the product¿s labeling and ifu.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: ON-X PROSTHETIC AORTIC VALVE WITH CONFORM-X SEWING RING AND EXTENDED HOLDER- 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: 10139104
• MDR Text Key: 194763812
• Report Number: 1649833-2020-00017
• 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: company representative,study
• Type of Report: Initial,Followup
• Report Date: 08/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: ONXACE-21
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 70 YR