BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONX AORTIC CONFORM EXT 25

    MDR report key: 10052138 · Received May 13, 2020

    Report

    Report Number
    1649833-2020-00014
    Event Type
    Injury
    Date Received
    May 13, 2020
    Date of Event
    January 15, 2020
    Report Date
    June 12, 2020
    Manufacturer
    ON-X LIFE TECHNOLOGIES, INC.
    Product Code
    LWQ
    PMA / PMN Number
    P000037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURING RECORDS FOR ONXACE-25, SN (B)(4) WERE REVIEWED BY QUALITY ASSURANCE/QUALITY CONTROL (QA/QC) 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 CLINICAL/MEDICAL REVIEW WAS PERFORMED OF THE AVAILABLE INFORMATION. ONXACE-25 SN (B)(4) WAS IMPLANTED IN THE MITRAL POSITION OF A 58-YEAR-OLD MALE PATIENT ON (B)(6) 2017 THE PATIENT IS A STUDY PARTICIPANT OF THE ON-X AORTIC PROSTHETIC HEART VALVE LOW DOSE WARFARIN POST APPROVAL STUDY {PL ID 106). A COMPLICATION EVENT DATED (B)(6) 2020 (944-DAYS POST-IMPLANT) WAS ENTERED IN THE STUDY DATABASE AND IS CURRENTLY UNDER REVIEW BY THE STUDY'S ADJUDICATION COMMITTEE. PER THE DISCHARGE REPORT, THE PATIENT WAS PRESENTED TO THE HOSPITAL "WITH SUDDEN ONSET OF EXPRESSIVE DYSPHASIA AND WAS FOUND TO HAVE AN ACUTE INFARCT IN THE LEFT INSULAR REGION. INR ON ADMISSION WAS 1.2. ¿WHILE WE KNOW THE TARGET INR WAS 1.8 (RANGE 1.5-2.0), WHICH APPEARS TO BE IN AGREEMENT WITH RECOMMENDATIONS CONTAINED IN THE INSTRUCTIONS FOR USE [IFU], A MEMO BY THE STUDY COORDINATOR NOTED, "PATIENT ADMITTED THEY HAD NOT BEEN DILIGENT WITH THEIR MEDICATION PRIOR TO THE EVENT WHICH MAY ACCOUNT FOR THE LOW INR." THE DISCHARGE REPORT NOTED THE PATIENT, "HAD AN ECHOCARDIOGRAM WHICH SHOWS NORMAL VALVE MOVEMENT...CT HEAD SHOWED NO ACUTE STROKE OR BLEED. MRI HEAD SHOWED AN ACUTE LEFT MCA INFARCT AFFECTING THE LEFT INSULAR CORTEX AND FRONTOTEMPORAL LOBE BUT ALSO SHOWED INDETERMINATE FRONTAL LOBE LESION.¿ WHILE THE STUDY DOCTOR CLASSIFIES THIS AS A THROMBOEMBOLISM, WE DON'T REALLY HAVE ENOUGH INFORMATION TO CLEARLY INDICATE THE CAUSE OF THE CLOT'S FORMATION AND THEREFORE, CANNOT SAY FOR CERTAIN WHAT CONTRIBUTION THE VALVE HAD TO THE EVENT. THE PATIENT WAS ULTIMATELY DISCHARGED AFTER RESULT FROM THE ANGIOGRAM PROCEDURE DATED 2020 JANUARY 20 INDICATING THE "CARDIOLOGY TEAM WERE HAPPY WITH VALVE FUNCTION.¿ THE PROACT STUDY RESULTS, FROM WHICH THE RECOMMENDED INR RANGE WAS DERIVED, STILL EXPERIENCED THROMBOSES, BUT AT A RATE NO DIFFERENT FROM PATIENTS UNDERGOING THE FORMER STANDARD-OF-CARE (INR 2.0 - 3.0). INDEED, THERE WERE TWO CASES FOR EACH OF THE CONTROL AND TREATMENT GROUPS FOR A NON-SIGNIFICANT STATISTICAL EVENT RATE OF 0.18 AND 0.21 % PER PATIENT-YEAR. RESPECTIVELY [PUSKAS 2018]. THROMBOSIS IS A RARE BUT KNOWN POTENTIAL COMPLICATION OF PROSTHETIC VALVE REPLACEMENT PFUJ OCCURRING IN THE ¿REAL WORLD¿ AT A HISTORICAL RATE OF 0.8% PER PATIENT-YEAR FOR RIGID HEART VALVES [ISO 5840:2005E]. THIS IS A CASE OF THROMBOEMBOLISM, BUT WE DO NOT KNOW THE CIRCUMSTANCES LEADING TO ITS FORMATION OTHER THAN THAT THE PATIENT WAS NOT COMPLIANT WITH TAKING THEIR MEDICATION. WHILE NOMINALLY PROPERLY TARGETED FOR AN INR OF 1.5-2.0, WE CANNOT CONCLUDE WHAT, IF ANY, CONTRIBUTION THE VALVE HAD TO IT. NO FURTHER ACTION IS REQUIRED WITHOUT ADDITIONAL INFORMATION. RISK MANAGEMENT PERFORMED A REVIEW OF THE AVAILABLE INFORMATION. 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 CLINICAL MEDICAL REPORT STATES CAUSE FOR EXPLANTATION AS: "THIS IS A CASE OF THROMBOEMBOLISM, BUT WE DO NOT KNOW THE CIRCUMSTANCES LEADING TO ITS FORMATION OTHER THAN THAT THE PATIENT WAS NOT COMPLIANT WITH TAKING THEIR MEDICATION. WHILE NOMINALLY PROPERLY TARGETED FOR AN INR OF 1.5-20., WE CANNOT CONCLUDE, WHAT IF ANY, CONTRIBUTION THE VALVE HAD TO IT." THE IFU PROVIDES INSTRUCTION ABOUT THE POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE USE OF PROSTHETIC HEART VALVES WHICH MAY LEAD TO EXPLANTATION AND REOPERATION. THE ON-X 614 HEART VALVE DESIGN FMEA COVERS THIS EVENT. THE ON-X HEART VALVE 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 PRODUCT'S LABELING AND IFU. NO ACTION NECESSARY. THE ON-X HEART VALVE 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 PRODUCT'S LABELING AND IFU. 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.

    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

    PATIENT #(B)(6) EXPERIENCED A THROMBOEMBOLISM. PRESENTATION TO HOSPITAL - SUDDEN EXPRESSIVE DYSPHASIA AND WEAKNESS LEFT LEG. INR 1.3 . PATIENT ADMITTED NOT BEING 100% COMPLIANT WITH MEDICATION. CT HEAD. MRI HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515168 ONX AORTIC CONFORM EXT 25 HEART-VALVE, MECHANICAL LWQ ON-X LIFE TECHNOLOGIES, INC. ONXACE-25

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| S WARFARIN AND ASPIRIN| WARFARIN AND ASPIRIN