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-21

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

Patient Problem Excessive Tear Production (2235)

Event Date 11/13/2018

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 information received from a returned implant registration card, patient received onxane-21, sn: (b)(4), (b)(6) 2017.The onxane-21 was replaced with the onxaap-21, sn (b)(4), (b)(6) 2018.Initial information received from the cardiothoracic surgical desk as follows: patient required intervention due to malfunctioning aortic valve.Additional information received from the surgeon is as follows: "the valve is in perfectly normal functioning shape.The reason for explant is almost complete avulsion, probably second to bacterial endocarditis, all stitches intact on the on-x sewing ring, nothing wrong with the valve.".

Event Description

According to information received from a returned implant registration card, patient received onxane-21 sn (b)(4).(b)(6)2017.The onxane-21 was replaced with the onxaap-21 sn (b)(4) (b)(6)2018.Initial information received from the cardiothoracic surgical desk as follows: patient required intervention due to malfunctioning aortic valve.Additional information received from the surgeon is as follows: "the valve is in perfectly normal functioning shape.The reason for explant is almost complete avulsion, probably second to bacterial endocarditis, all stitches intact on the on-x sewing ring, nothing wrong with the valve.".

Manufacturer Narrative

Correction - date of event, date of explant unknown.The manufacturing records for the onxane-21 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.During the investigation no non-conformances or deviations were noted.A review of the available information was performed.A 58.57 year old male patient implanted with onxane-21, sn (b)(4) , on (b)(6)2017 and required explant (date unconfirmed) and subsequent replacement via onxaap-21.Surgeon stated, "the valve is in perfectly normal functioning shape.The reason for explant is almost complete evulsion [avulsion], probably second to bacterial endocarditis , all stitches intact on the on-x sewing ring, (pictures attached).Nothing wrong with the valve." pictures provided include explanted valve with sutures and pledgets present with annular tissue which provide evidence of annular valve avulsion due to endocarditis effects on annular tissue.Alleged bacterial endocarditis, per the surgeon, occurring nearly one year post implant is unlikely related to the valve.Furthermore, on-x valves are terminally sterilized prior to distribution.Additionally, per the surgeon, there was "nothing wrong with the valve." based on the available information, root cause for the explant per the surgeon is endocarditis.Additionally, there is no suggestion, evidence, or indication that the original valve, onxane-21 sn (b)(4) , was functionally deficient except that the patient's condition warranted the placement of a replacement ascending aorta.Nevertheless, endocarditis as well as subsequent explant are known potential adverse events associated with prosthetic valve replacement [instructions for use].For rigid heart valves, endocarditis occurs at a historic rate of 1.2%/patient-year [iso 5840:2005].Root cause for the explant per the surgeon is endocarditis.Root cause for the endocarditis per the surgeon is alleged to be bacterial in origin.No further action is required at this time.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 ANATOMIC SEWING RING WITH 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: 8150457
• MDR Text Key: 129900036
• Report Number: 1649833-2018-00174
• 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,health
• Type of Report: Initial,Followup
• Report Date: 02/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 06/19/2023
• Device Model Number: ONXANE-21
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 11/29/2018
• Date Manufacturer Received: 11/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR