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-25

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

Patient Problem Endocarditis (1834)

Event Date 01/27/2020

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, onxace-25, sn (b)(4) was implanted on (b)(6) 2019 and was explanted and replaced with onxace-27/29, sn (b)(4) on (b)(6) 2020 due to endocarditis.

Manufacturer Narrative

The manufacturing records for onxace-25, 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.According to the implant registration card (irc), an onxace-25, sn (b)(6) was implanted (b)(6) 2019 in the aortic position of a 59-year-old male.On (b)(6) 2020 (1 year 3 days post implant) another irc indicated onxace-27/29, sn (b)(6) was reported as implanted in the aortic position of the same patient.It was presumed that the initial on-x valve was explanted.Subsequent information requested of the institution confirmed that the onxace-25 had been explanted, that the reason was endocarditis, that the valve had not been deficient, and that the patient was discharged.Of note, it is unlikely the on-x valve was the source of the infection as on-x valves undergo a validated terminal sterilization process during manufacturing.The general reason to explant a prosthesis due to endocarditis (infection) is paravalvular leak (pvl) as a result of deterioration of the annular tissue that anchors the valve in place, though that is not explicitly stated in this case.The instructions for use [ifu] for the on-x valve acknowledge endocarditis as a risk factor (as well as prosthetic perivalvular leak) in prosthetic valve replacement which may result in reoperation and explantation.The historical record shows an occurrence rate of 1.2%/patient-year for endocarditis and 0.6%/patient-year for major pvl for recipients of rigid heart valve substitutes [iso 5840:2005].We have no evidence of any valvular malfunction.Endocarditis is the underlying cause of the explantation and replacement of the original on-x prosthesis.A risk assessment was performed.It is unlikely the on-x valve was the source of the infection as on-x valves undergo a validated terminal sterilization procedure during manufacturing.The review of the device history record (dhr) found that the valve met all specifications and testing requirements.There were no issues found in the manufacture of the device.The on-x ifu lists endocarditis as a potential adverse event.The reported event is also identified in the on-x heart valve design fmea.The on-x valve risk management file thoroughly identifies the process and product hazards for approved indications.Each individual hazard 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 event does not identify additional hazards or modify the probability or 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: 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 ln., bldg. b; austin TX 78752
• MDR Report Key: 9817667
• MDR Text Key: 183564559
• Report Number: 1649833-2020-00001
• 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
• Type of Report: Initial,Followup
• Report Date: 04/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ONXACE-25
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/19/2020
• Initial Date FDA Received: 03/11/2020
• Supplement Dates Manufacturer Received: 02/19/2020
• Supplement Dates FDA Received: 04/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 60 YR