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

Model Number ONXANE-27/29

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Insufficiency, Valvular (1926); No Code Available (3191)

Event Date 08/22/2018

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 implant registration cards, onxane-27/29 sn (b)(4), implanted (b)(6) 2018 and explanted (b)(6) 2018.The valve was replaced with onxane-25 sn (b)(4).

Manufacturer Narrative

The manufacturing records for the onxane-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.A review of the available information was performed.A 51.04 male patient implanted with onxane-27/29, sn (b)(6) on (b)(6) 2018 indicated for endocarditis with repair of annular abscess, very poor annular tissue noted per op notes.Patient developed paravalvular leak (pvl) which progressed from mild to severe and required explant on (b)(6) 2018 and subsequent replacement via onxane-25.Pseudoaneurysm extending the length of the right coronary cusp repaired.The instructions for use for the on-x valve acknowledge paravalvular leak as a potential complication following prosthetic valve replacement, which may lead to re-operation 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)].Root cause for the pvl is prior endocarditis related annular tissue friability.There is no evidence to suggest that the valve contributed to the pvl and ultimate explant.No further action 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 cards, onxane-27/29 (b)(6), implanted (b)(6) 2018 and explanted (b)(6) 2018.The valve was replaced with onxane-25 (b)(6).

• Brand Name: ON-X PROSTHETIC AORTIC VALVE WITH ANATOMIC SEWING RING WITH 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: 8651639
• MDR Text Key: 146419639
• Report Number: 1649833-2019-00031
• 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: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 07/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 10/27/2023
• Device Model Number: ONXANE-27/29
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/17/2019
• Date Manufacturer Received: 05/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR