BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HANCOCK II AORTIC BIOPROSTHETIC HEART VALVE

    MDR report key: 7969555 · Received October 16, 2018

    Report

    Report Number
    2025587-2018-02744
    Event Type
    Injury
    Date Received
    October 16, 2018
    Date of Event
    July 28, 2018
    Report Date
    October 16, 2018
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    DYE
    PMA / PMN Number
    P980043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: KIVINIEMI T ET AL. PERFORMANCE OF CHA2DS2-VASC SCORE FOR STROKE PREDICTION AFTER SURGICAL AORTIC VALVE REPLACEMENT. J THORAC CARDIOVASC SURG. 2018 JUL 29. PII: S0022-5223(18)32030-0. DOI: 10.1016/J.JTCVS.2018.06.096. EPUB 2018 JUL 28. EARLIEST DATE OF PUBLISH USED FOR EVENT DATE. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATIONS. (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REGARDING THE PERFORMANCE OF THE CHA2DS2-VASC SCORE IN PREDICTING STROKE, TRANSIENT ISCHEMIC ATTACK, AND MAJOR BLEEDS IN PATIENTS UNDERGOING SURGICAL AORTIC VALVE REPLACEMENT WITH A BIOPROSTHESIS. ALL DATA WERE COLLECTED FROM 4 CENTERS BETWEEN 2002 AND 2014. THE STUDY POPULATION INCLUDED 714 PATIENTS (PREDOMINANTLY FEMALE; MEAN AGE (B)(6) YEARS), AN UNSPECIFIED NUMBER OF WHICH WERE IMPLANTED WITH A MEDTRONIC HANCOCK II BIOPROSTHETIC VALVE OR A MEDTRONIC MOSAIC/MOSAIC ULTRA BIOPROSTHETIC VALVE. NO SERIAL NUMBERS WERE PROVIDED. IN-HOSPITAL PATIENT DEATHS WERE EXCLUDED FROM THE STUDY ANALYSIS. BASED ON THE LIMITED AVAILABLE INFORMATION, MEDTRONIC PRODUCT DID NOT CAUSE OR CONTRIBUTE TO THESE DEATHS. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: STROKE, CARDIOEMBOLIC STROKE, TRANSIENT ISCHEMIC ATTACK, NEW-ONSET ATRIAL FIBRILLATION AND MAJOR BLEEDS. MULTIPLE MANUFACTURERS WERE NOTED IN THE LITERATURE; BASED ON THE AVAILABLE INFORMATION A DIRECT CORRELATION COULD NOT BE MADE BETWEEN MEDTRONIC PRODUCT AND THE OBSERVED ADVERSE EVENTS. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    809281 HANCOCK II AORTIC BIOPROSTHETIC HEART VALVE HEART-VALVE, REPLACEMENT DYE MEDTRONIC HEART VALVES DIVISION T505

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Life Threatening