BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE TRANSCATHETER AORTIC VALVE

    MDR report key: 7156428 · Received January 1, 2018

    Report

    Report Number
    2025587-2018-02593
    Event Type
    Injury
    Date Received
    January 1, 2018
    Date of Event
    August 19, 2016
    Report Date
    January 1, 2018
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: WILCZEK K CONDUCTION DISTURBANCES AFTER TRANSCATHETER AORTIC VALVE IMPLANTATION PROCEDURES ¿ PREDICTORS AND MANAGEMENT. POSTEPY KARDIOL INTERWENCYJNEJ. 2016; 12(3): 203¿211, DOI: 10.5114/AIC.2016.61640. 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 META-ANALYSIS REGARDING CONDUCTION DISTURBANCES AFTER TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI). ALL DATA WERE COLLECTED FROM MULTIPLE CENTERS. THE STUDY POPULATION INCLUDED AN UNSPECIFIED NUMBER OF PATIENTS, AN UNSPECIFIED NUMBER OF WHICH WERE IMPLANTED WITH MEDTRONIC COREVALVE AND EVOLUTR (SERIAL NUMBERS NOT PROVIDED). AMONG ALL PATIENTS ADVERSE EVENTS INCLUDED: DEEP IMPLANT, LEFT BUNDLE BRANCH BLOCK (LBBB), RIGHT BUNDLE BRANCH BLOCK (RBBB), BRADYCARDIA, COMPLETE HEART BLOCK (CHB), ATRIO-VENTRICULAR (AV) BLOCK, OVERSIZING, PATIENT-PROSTHESIS MISMATCH, PERMANENT PACEMAKER IMPLANT, VASCULAR AND BLEEDING COMPLICATIONS RELATED TO THE DELIVERY CATHETER SYSTEM (DCS). MULTIPLE MANUFACTURERS WERE NOTED IN THE LITERATURE; BASED ON THE AVAILABLE INFORMATION A DIRECT CORRELATION COULD NOT BE MADE BETWEEN 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
    50 COREVALVE TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION CRS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention