BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE AORTIC ROOT BIOPROSTHESIS

    MDR report key: 3952320 · Received July 23, 2014

    Report

    Report Number
    2025587-2014-00508
    Event Type
    Injury
    Date Received
    July 23, 2014
    Report Date
    August 11, 2014
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P970031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED AS THE SERIAL NUMBER WAS NOT PROVIDED. CUSPAL TEARS LEADING TO REGURGITATION IS A KNOWN RISK. WITHOUT THE RETURN OF THE VALVE FOR ANALYSIS, A ROOT CAUSE OF THE CUSPAL TEAR COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT REMAINS IMPLANTED AND THEREFORE HAS NOT BEEN RETURNED TO MEDTRONIC. ADDITIONAL INFORMATION REGARDING THE DEVICE AND THE PATIENT MEDICAL ISSUES/DEMOGRAPHICS HAS BEEN REQUESTED FROM THE ARTICLE¿S AUTHOR CONTACT. (B)(4). "SPONTANEOUS TEAR IN THE NONCORONARY CUSP OF THE MEDTRONIC FREESTYLE BIOPROSTHESIS" AUTHORS: IVAN KNEZEVIC, M.D., M.SC.; TOMAZ MESAR, M.D.; KATJA AZMAN JUVAN, M.D., PH.D.; MATIJA JELENC, M.D., PH.D.; AND BOJAN VRTOVEC, M.D., PH.D. DOI: 10.1111/JOCS.12211 (J CARD SURG 2013;28:711¿712).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT THREE YEARS FOLLOWING THE IMPLANT OF THIS STENTLESS BIOPROSTHESIS, THE PATIENT WAS ADMITTED TO A HOSPITAL FOR HEART FAILURE. ECHOCARDIOGRAPHY SHOWED SEVERE AORTIC VALVE REGURGITATION ORIGINATING IN THE AREA OF THE NONCORONARY CUSP. AT REOPERATION, THERE WAS AN OBSERVED TEAR IN THE NONCORONARY CUSP. THE DEVICE¿S CUSPS WERE EXCISED, LEAVING THE WALL OF THE DEVICE IN SITU. A NON-MEDTRONIC STENTLESS BIOPROSTHESIS WAS IMPLANTED IN THIS DEVICE. IT WAS REPORTED THERE WERE NO SUBSEQUENT ADVERSE PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430271 FREESTYLE AORTIC ROOT BIOPROSTHESIS HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION 995

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Required Intervention