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

Model Number ONXACE-27/29

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problem Insufficiency, Valvular (1926)

Event Date 04/15/2019

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 implant registration card received back from the hospital, patient received onxace-27/29 sn (b)(4) (b)(6) 2019 in the aortic position.Records indicate the same patient received onxace-25 sn (b)(4) (b)(6) 2019 also in the aortic position.This investigation is relegated to onxace-27/29 sn (b)(4).There is no alleged deficiency towards onxace-25 serial number (b)(4).According to additional information onxace-27/29 sn (b)(4) was explanted due to pvl.

Manufacturer Narrative

The manufacturing records for the onxace-27/29 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.A review of the available information was performed.A 50.89-year-old male patient implanted with onxace-27/29 on (b)(6) 2019 and required explant and replacement via onxace-25 on (b)(6) 2019.The initial report states surgeon implanted an onxace-27/29 initially.The cardiologist confirmed a paravalvular leak [pvl].The valve's sutures had pulled away from the annulus.The surgeon closed the leak with a couple of sutures to the satisfaction of the cardiologist in the operating room.In the following days, the leak had come back to some degree and the patient wanted to replace the valve which they did with the onxace-25.Additional information is unknown.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, pvl occurs at a rate 1.2 % per patient-year for all pvls, while major pvl occurs at a rate of 0.6 % per patient-year for rigid heart valve substitutes [iso 5840:2005(e)].Definitive root cause for pvl cannot be ascertained based on the available information.However, it is likely that the annulus was oversized resulting in pvl as evidenced by the decision to downsize the valve to a 25mm in the subsequent implant.There is no evidence to suggest that the valve contributed to the pvl and ultimate explant.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 implant registration card received back from the hospital, patient received onxace-27/29 sn (b)(6) on (b)(6) 2019 in the aortic position.Records indicate the same patient received onxace-25 sn (b)(6) on (b)(6) 2019 also in the aortic position.This investigation is relegated to onxace-27/29 sn (b)(6).There is no alleged deficiency towards onxace-25 serial number (b)(6).According to additional information onxace-27/29 sn (b)(6) was explanted due to pvl.

• Brand Name: ON-X PROSTHETIC AORTIC VALVE WITH CONFORM-X SEWING RING AND EXTENDED HOLDER
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES, INC.; 1300 e. anderson lane, bldg b; austin TX 78752
• MDR Report Key: 8601557
• MDR Text Key: 144754906
• Report Number: 1649833-2019-00029
• 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: other,user facility
• Type of Report: Initial,Followup
• Report Date: 07/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: ONXACE-27/29
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/23/2019
• Date Manufacturer Received: 04/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR