BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE TRANSCATHETER AORTIC VALVE

    MDR report key: 7104064 · Received December 11, 2017

    Report

    Report Number
    2025587-2017-02384
    Event Type
    Injury
    Date Received
    December 11, 2017
    Date of Event
    September 25, 2015
    Report Date
    December 11, 2017
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: STORTECKY S. VALIDATION OF THE VALVE ACADEMIC RESEARCH CONSORTIUM BLEEDING DEFINITION IN PATIENTS WITH SEVERE AORTIC STENOSIS UNDERGOING TRANSCATHETER AORTIC VALVE IMPLANTATION. J AM HEART ASSOC. 2015 SEP 25;4(10):E002135. DOI: 10.1161/JAHA.115.002135. 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. 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 IMPACT OF BLEEDING IN PATIENTS WITH SEVERE AORTIC STENOSIS UNDERGOING TRANSCATHETER AORTIC VALVE IMPLANTATION. ALL DATA WERE COLLECTED FROM SINGLE CENTER REGISTRY BETWEEN AUGUST 2007 AND APRIL 2012. THE STUDY POPULATION INCLUDED 489 PATIENTS (PREDOMINANTLY FEMALE; MEAN AGE 82.5 YEARS), 267 OF WHICH WERE IMPLANTED WITH MEDTRONIC COREVALVE DEVICE. SERIAL NUMBERS WERE NOT PROVIDED. AMONG ALL PATIENTS, 30-DAY AND 12 MONTHS MORTALITY OCCURRED DUE TO UNSPECIFIED CAUSES. BASED ON THE AVAILABLE INFORMATION, NONE OF THE DEATHS WERE ATTRIBUTED TO MEDTRONIC PRODUCT. AMONG ALL PATIENTS ADVERSE EVENTS INCLUDED: PERMANENT PACEMAKER IMPLANTATION, AORTIC REGURGITATION, LIFE-THREATENING BLEEDING, VASCULAR COMPLICATIONS, AND LIFE-THREATENING VASCULAR ACCESS SITE BLEEDING. BASED ON THE AVAILABLE INFORMATION, THESE EVENTS MAY HAVE BEEN ATTRIBUTED TO A MEDTRONIC PRODUCT. HOWEVER AS MULTIPLE MANUFACTURERS WERE NOTED IN THE LITERATURE, A DIRECT CORRELATION COULD NOT BE MADE BETWEEN THE OBSERVED ADVERSE EVENTS AND THE MEDTRONIC PRODUCT. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    885911 COREVALVE TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION CRS

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Life Threatening