BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCUTRAK DELIVERY CATHETER SYSTEM

    MDR report key: 7062946 · Received November 28, 2017

    Report

    Report Number
    2025587-2017-02278
    Event Type
    Injury
    Date Received
    November 28, 2017
    Date of Event
    September 2, 2015
    Report Date
    November 28, 2017
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: SALEH, N. MD ET AL. FEMORAL ACCESS-RELATED COMPLICATIONS DURING PERCUTANEOUS TRANSCATHETER AORTIC VALVE IMPLANTATION COMPARING SINGLE VERSUS DOUBLE PROSTAR XL DEVICE CLOSURE. CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS (2015) 86:1255¿1261 DOI 10.1002/CCD.25966 EARLIEST DATE OF E-PUBLISH/PUBLISH USED FOR EVENT DATE. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION, IT CANNOT BE DETERMINED WHETHER THIS EVENT HAS BEEN PREVIOUSLY REPORTED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REVIEW REGARDING ACCESS SITE CLOSURE OUTCOMES WITH THE USE OF CLOSURE DEVICES AFTER THE IMPLANT OF A TRANSCATHETER AORTIC VALVE. ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN 2012 AND 2014. THE STUDY POPULATION INCLUDED 126 PATIENTS, ALL OF WHICH WERE IMPLANTED WITH A COREVALVE. SERIAL NUMBERS WERE NOT PROVIDED. THE STUDY POPULATION WAS PREDOMINANTLY MALE; MEAN AGE 83 ±6 YEARS AMONG ALL PATIENTS ADVERSE EVENTS INCLUDED: VASCULAR COMPLICATIONS AND BLOOD LOSS. BASED ON THE AVAILABLE INFORMATION, THESE EVENTS MAY HAVE BEEN ATTRIBUTED TO A MEDTRONIC PRODUCT OR MAY HAVE BEEN DUE TO THE CLOSURE DEVICE. A DIRECT CORRELATION COULD NOT BE MADE BETWEEN THE OBSERVED ADVERSE EVENTS AND THE MEDTRONIC PRODUCT. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844421 ACCUTRAK DELIVERY CATHETER SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION DCS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Life Threatening