BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE REVALVING SYSTEM

    MDR report key: 6023484 · Received October 12, 2016

    Report

    Report Number
    2025587-2016-01608
    Event Type
    Injury
    Date Received
    October 12, 2016
    Date of Event
    August 19, 2016
    Report Date
    October 18, 2016
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: WILCZEK K ET AL. CONDUCTION DISTURBANCES AFTER TRANSCATHETER AORTIC VALVE IMPLANTATION PROCEDURES ¿ PREDICTORS AND MANAGEMENT. ADV INTERV CARDIOL 2016; 12, 3 (45): 203¿211. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION, IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED.

    Additional Manufacturer Narrative · 1

    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 COMPREHENSIVE ANALYSIS OF SEVENTY ARTICLES PUBLISHED BETWEEN 2007 TO 2016 OF THE MOST COMMON CONDUCTION DISTURBANCES FOLLOWING TRANSCATHETER AORTIC VALVE IMPLANT (TAVI). THE PATIENT POPULATION WAS NOT DEFINED, NOR WERE THE NUMBER OF PATIENTS IMPLANTED WITH A MEDTRONIC COREVALVE OR COREVALVE EVOLUT R TRANSCATHETER BIOPROSTHETIC VALVE (SERIAL NUMBERS NOT PROVIDED). ADVERSE EVENTS WERE PROVIDED AS PERCENTAGES OF AGGREGATED STUDIES. AMONG ALL COREVALVE PATIENTS IN STUDIES OF MORE THAN 100 PARTICIPANTS, UP TO 50.0% EXPERIENCED LEFT BUNDLE BRANCH BLOCK (LBBB), 16% HIGH-GRADE ATRIO-VENTRICULAR BLOCK (AVB), AND 27.4% PERMANENT PACEMAKER IMPLANT. FOR COREVALVE PATIENTS IN STUDIES OF LESS THAN 100 PARTICIPANTS, UP TO 48% EXPERIENCED LEFT BUNDLE BRANCH BLOCK (LBBB), 27% HIGH-GRADE ATRIO-VENTRICULAR BLOCK (AVB), AND 55.9% PERMANENT PACEMAKER IMPLANT. FOR COREVALVE EVOLUT R PATIENTS IN STUDIES OF LESS THAN 100 PARTICIPANTS, 8.3% EXPERIENCED LBBB. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION FROM THE PHYSICIAN/AUTHOR STATED THAT MEDTRONIC COREVALVE MAY HAVE CAUSED OR CONTRIBUTED TO THE NEED FOR A PERMANENT PACEMAKER, AND THE MEAN PATIENT AGE WAS 70 YEARS AND WEIGHT WAS 60 KG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    675178 COREVALVE REVALVING SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION CRS

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention