BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE AORTIC ROOT BIOPROSTHESIS

    MDR report key: 6530604 · Received April 28, 2017

    Report

    Report Number
    2025587-2017-00713
    Event Type
    Injury
    Date Received
    April 28, 2017
    Date of Event
    March 28, 2017
    Report Date
    May 23, 2017
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P970031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: KARIMI A ET AL. HIGH-RISK TRANS-CATHETER AORTIC VALVE REPLACEMENT IN A FAILED FREESTYLE VALVE WITH LOW CORONARY HEIGHT CARDIOL THER. 2017 MAR 28. DOI: 10.1007/S40119-017-0088-4. 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. (B)(4). A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE OF A (B)(6) YEAR-OLD MALE PATIENT WITH A BICUSPID AORTIC VALVE WHO UNDERWENT IMPLANT OF A MEDTRONIC FREESTYLE STENTLESS AORTIC ROOT BIOPROSTHESIS (SERIAL NUMBER NOT PROVIDED). TEN YEARS FOLLOWING THE VALVE IMPLANT, THE PATIENT PRESENTED WITH ELEVATED CARDIAC ENZYMES AND DECOMPENSATED HEART FAILURE. TRANSTHORACIC ECHOCARDIOGRAM (TTE) REVEALED SEVERE AORTIC INSUFFICIENCY WITH AN ELEVATED MEAN GRADIENT OF 26MMHG AND LEFT VENTRICULAR DYSFUNCTION. AN ELONGATED MOBILE DENSITY WAS NOTED ON THE VALVE THOUGHT TO BE EITHER A HEALED VEGETATION, AS BLOOD CULTURES WERE NEGATIVE, OR DEGENERATIVE VALVE LEAFLET PROLAPSE. COMPUTED TOMOGRAPHY (CT) SCAN SHOWED THE BIOPROSTHETIC TO BE CALCIFIED. SUBSEQUENTLY, A NON-MEDTRONIC TRANSCATHETER BIOPROSTHETIC VALVE WAS IMPLANTED VALVE-IN-VALVE. DURING THE IMPLANT, IT WAS NOTED THAT THE PIGTAIL WAS USED AS A MARKER DUE TO THE FREESTYLE ROOT NOT POSSESSING A RADIOPAQUE RING MARKER OR VISIBLE POSTS. FOLLOWING THE IMPLANT, THE FINAL ROOT ANGIOGRAM SHOWED THE AORTIC INSUFFICIENCY WAS RESOLVED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE PHYSICIAN/AUTHOR STATED THAT MEDTRONIC PRODUCT DID NOT CAUSE OR CONTRIBUTE TO THE ADVERSE EVENTS, AND PROVIDED THE VALVE SIZE (27MM) WITHOUT SERIAL NUMBERS, AND THE PATIENT'S WEIGHT ((B)(6)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310914 FREESTYLE AORTIC ROOT BIOPROSTHESIS HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION 995

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention