BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIC AORTIC BIOPROSTHETIC HEART VALVE

    MDR report key: 5084311 · Received September 17, 2015

    Report

    Report Number
    2025587-2015-00981
    Event Type
    Injury
    Date Received
    September 17, 2015
    Date of Event
    March 24, 2015
    Report Date
    September 29, 2015
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    GKN
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TITLE: EARLY STENOSIS OF AN AORTIC PORCINE BIOPROSTHESIS DUE TO THROMBOSIS: CASE REPORT AND LITERATURE REVIEW CITATION: J THORAC CARDIOVASC SURG 2015;149:E83-6 (HTTP://DX.DOI.ORG/10.1016/J.JTCVS.2015.02.039) AUTHORS: MASAHIRO DOHI, MD, KIYOSHI DOI, MD, PHD, AND HITOSHI YAKU, MD, PHD DATE OF PUBLISH USED FOR EVENT DATE.

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO DEVICE WAS RETURNED AND NO UNIQUE DEVICE IDENTIFIER NUMBERS WERE PROVIDED. BASED ON THE AVAILABLE INFORMATION A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED AND ROOT CAUSE COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REVIEW OF AN ARTICLE DESCRIBING EARLY STENOSIS AND THROMBOSIS OF AORTIC BIOPROSTHETIC VALVES. THE CASE REPORT WITHIN THE ARTICLE DID NOT REFERENCE MEDTRONIC PRODUCTS, HOWEVER A TABLE SUMMARY REFERENCE 18 MEDTRONIC SURGICAL BIOPROSTHETIC VALVES FROM TWO DEVICE FAMILIES (SERIAL NUMBERS NOT REPORTED) NOTED WITH EARLY THROMBOSIS (EXCLUDING PATIENTS ON ANTICOAGULATION OR THROMBOLYTIC THERAPY). PER THE TABLE SUMMARY, THE PATIENTS WITH MEDTRONIC VALVES HAD A MEAN AGE OF 70.5 YEARS, AND A MEAN TIME FROM IMPLANT TO THROMBOSIS OCCURRENCE OF 40.7 MONTHS. OF THESE 18 PATIENTS, ALL BUT FOUR WERE NOTED AS HAVING UNDERGONE INTERVENTION TO REPLACE THE THROMBOTIC VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    REQUESTS FOR ADDITIONAL INFORMATION PROVIDED NO FURTHER DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616190 MOSAIC AORTIC BIOPROSTHETIC HEART VALVE TIMER, CLOT, AUTOMATED GKN MEDTRONIC HEART VALVES DIVISION 30525

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Required Intervention