BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATHETER DCS DELIVERY SYSTEM

    MDR report key: 6825711 · Received August 28, 2017

    Report

    Report Number
    2025587-2017-01489
    Event Type
    Injury
    Date Received
    August 28, 2017
    Date of Event
    May 30, 2017
    Report Date
    August 4, 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: A. OLASINSKA-WISNIEWSKA ET AL. "FEMORAL ARTERY ANATOMY-TAILORED APPROACH IN TRANSCATHETER AORTIC VALVE IMPLANTATION" ADV INTERV CARDIOL 2017; 13, 2 (48): 150¿156; DOI: HTTPS://DOI.ORG/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. 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 REGARDING FEMORAL ARTERY ANATOMY-TAILORED APPROACH IN TRANSCATHETER AORTIC VALVE IMPLANTATION. ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN SEPTEMBER 2010 AND SEPTEMBER 2015. THE STUDY POPULATION INCLUDED 152 PATIENTS (PREDOMINANTLY FEMALE, MEAN AGE 79 YEARS), 101 OF WHICH WERE IMPLANTED WITH MEDTRONIC COREVALVE (SERIAL NUMBERS NOT PROVIDED). AMONG ALL PATIENTS FOUR DEATHS OCCURRED. BASED ON THE AVAILABLE INFORMATION, NONE OF THE DEATHS WERE ATTRIBUTED TO MEDTRONIC PRODUCT. AMONG ALL PATIENTS ADVERSE EVENTS INCLUDED: HEMATOMA, PSEUDOANEURYSM, ACCESS SITE BLEEDING, FEMORAL ARTERY DISSECTION, POST-PROCEDURAL BLEEDING, RETROPERITONEAL BLEEDING, ILIAC ARTERY INJURY WITH MAJOR BLEEDING, MINOR BLEEDING, LIFE-THREATENING BLEEDING. BASED ON THE AVAILABLE INFORMATION, THESE ADVERSE EVENTS MAY HAVE BEEN ATTRIBUTED TO MEDTRONIC PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605014 CATHETER DCS DELIVERY SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION DCS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Life Threatening| R