BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONX ASCENDING AORTIC 27/29

    MDR report key: 10202994 · Received June 26, 2020

    Report

    Report Number
    1649833-2020-00021
    Event Type
    Injury
    Date Received
    June 26, 2020
    Date of Event
    June 9, 2020
    Report Date
    August 31, 2020
    Manufacturer
    ON-X LIFE TECHNOLOGIES, INC.
    Product Code
    LWQ
    PMA / PMN Number
    P000037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    D3 AND G1 CHANGED TO ON-X LIFE TECHNOLOGIES, INC. THE ONXAAP-27/29 SN: (B)(6) WAS IMPLANTED ON (B)(6) 2013 IN THE AORTIC POSITION OF A MALE PATIENT. THIS VALVED CONDUIT WAS REPLACED ON (B)(6) 2020 (6.5 YEARS POST-IMPLANT) BY ANOTHER ON-X VALVED CONDUIT OF THE SAME SIZE, ONXAAP 27/29 SN: (B)(6); NO REASON GIVEN AND NO ADDITIONAL INFORMATION WAS PROVIDED DESPITE MULTIPLE ATTEMPTS TO OBTAIN IT. WITHOUT ANY ADDITIONAL INFORMATION, WE SIMPLY DO NOT HAVE ANY EVIDENCE TO INDICATE WHAT, IF ANY, CONTRIBUTION THE VALVE HAD TO THE DECISION FOR ITS EXPLANATION. ALTHOUGH THERE IS NO EVIDENCE OF VALVE INVOLVEMENT, THE INSTRUCTIONS FOR USE FOR THE ON-X AAP LISTS RE-OPERATION AND EXPLANTATION AS POSSIBLE OUTCOMES OF COMPLICATIONS ASSOCIATED WITH MECHANICAL HEART VALVE REPLACEMENT [IFU]. IN THIS CASE, THOUGH, WE DO NOT KNOWN WHAT COMPLICATION PRECIPITATED THE SEQUENCE OF EVENTS LEADING TO A DIAGNOSIS RECOMMENDING ITS REMOVAL. THERE IS INSUFFICIENT INFORMATION TO INDICATE A ROOT CAUSE FOR THE DECISION LEADING TO THE EXPLANTATION OF THE ORIGINAL ON-X ASCENDING AORTIC PROSTHESIS. NO FURTHER ACTION IS REQUIRED WITHOUT ADDITIONAL INFORMATION. THE MANUFACTURING RECORDS FOR SERIAL NUMBER (B)(6) WAS REVIEWED. 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 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 PARAGRAPH ABOVE STATES: WITHOUT ANY ADDITIONAL INFORMATION, WE SIMPLY DO NOT HAVE ANY EVIDENCE TO INDICATE, WHAT, IF ANY, CONTRIBUTION THE VALVE HAD TO THE DECISION FOR ITS EXPLANTATION. ALTHOUGH THERE IS NO EVIDENCE OF VALVE INVOLVEMENT, THE INSTRUCTIONS FOR USE FOR THE ONXAAP LISTS REOPERATION AND EXPLANTATION AS POSSIBLE OUTCOMES OF COMPLICATIONS ASSOCIATED WITH MECHANICAL HEART VALVE REPLACEMENT (IFU). IN THIS CASE, THOUGH, WE DO NOT KNOW WHAT COMPLICATION PRECIPITATED THE SEQUENCE OF EVENTS LEADING TO A DIAGNOSIS RECOMMENDING ITS REMOVAL. THE ON-X AAP RISK MANAGEMENT FILE THOROUGHLY IDENTIFIES THE PROCESS AND PRODUCT HAZARDS FOR APPROVED INDICATIONS. EACH INDIVIDUAL HAZARD IS MITIGATED AND REDUCED AS LOW AS POSSIBLE BY DESIGN AND PROCESS. POST PRODUCTION RESIDUAL RISK IS COMMUNICATED IN THE PRODUCTS LABELING AND IFU. NO ACTION NECESSARY. THIS EVENT DOES NOT IDENTIFY ADDITIONAL HAZARDS OR MODIFY THE PROBABILITY AND 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.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORT RECEIVED ONXAAP 27/29 SN: (B)(6) WAS IMPLANTED ON (B)(6) 2013. THIS VALVE WAS EXPLANTED ON (B)(6) 2020 AND REPLACED WITH ONXAAP SN: (B)(6). THIS INVESTIGATION IS RELEGATED TO ONXAAP 27/29 SN: (B)(6). MULTIPLE ATTEMPTS TO GATHER ADDITIONAL INFORMATION HAVE GONE UNMET.

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORT RECEIVED ONXAAP 27/29 SN: (B)(4) WAS IMPLANTED ON (B)(6) 2013. THIS VALVE WAS EXPLANTED ON (B)(6) 2020 AND REPLACED WITH ONXAAP SN: (B)(4). THIS INVESTIGATION IS RELEGATED TO ONXAAP 27/29 SN: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667591 ONX ASCENDING AORTIC 27/29 HEART-VALVE, MECHANICAL LWQ ON-X LIFE TECHNOLOGIES, INC. ONXAAP-27/29

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Life Threatening