BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCUTRAK DELIVERY CATHETER SYSTEM

    MDR report key: 7058135 · Received November 25, 2017

    Report

    Report Number
    2025587-2017-02261
    Event Type
    Injury
    Date Received
    November 25, 2017
    Date of Event
    May 30, 2017
    Report Date
    November 25, 2017
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: OLASINSKA-WISNIEWSKA A FEMORAL ARTERY ANATOMY-TAILORED APPROACH IN TRANSCATHETER AORTIC VALVE IMPLANTATION POSTEPY KARDIOL INTERWENCYJNEJ. 2017;13(2):150-156. DOI: 10.5114/PWKI.2017.68050 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.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REGARDING FEMORAL ARTERY ANATOMY-TAILORED APPROACH IN TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI). ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN 2010 AND 2015. THE STUDY POPULATION INCLUDED 101 PATIENTS (PREDOMINANTLY FEMALE; MEAN AGE 79 YEARS), ALL OF WHICH WERE IMPLANTED WITH MEDTRONIC COREVALVE (SERIAL NUMBERS NOT PROVIDED). AMONG ALL PATIENTS IN-HOSPITAL AND 30-DAY MORTALITY OCCURRED INCLUDING TWO VASCULAR-COMPLICATION RELATED DEATHS AND ONE RELATED TO VENTRICULAR RUPTURE. BASED ON THE AVAILABLE INFORMATION, NONE OF THE DEATHS WERE ATTRIBUTED TO MEDTRONIC PRODUCT. AMONG ALL PATIENTS ADVERSE EVENTS INCLUDED: MODERATE PARAVALVULAR LEAK (PVL), STROKE, PERMANENT PACEMAKER IMPLANT. ALSO, VASCULAR-ACCESS COMPLICATIONS INCLUDING HEMATOMA, PSEUDOANEURYSM, BLEEDING AND DISSECTION REQUIRING INTERVENTION. MULTIPLE MANUFACTURERS WERE NOTED IN THE LITERATURE; BASED ON THE AVAILABLE INFORMATION A DIRECT CORRELATION COULD NOT BE MADE BETWEEN ALL OF THE OBSERVED ADVERSE EVENTS AND MEDTRONIC PRODUCT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837183 ACCUTRAK DELIVERY CATHETER SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION DCS-C5-16FR-L UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention