BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE TRANSCATHETER AORTIC VALVE

    MDR report key: 8002150 · Received October 24, 2018

    Report

    Report Number
    2025587-2018-02839
    Event Type
    Injury
    Date Received
    October 24, 2018
    Date of Event
    June 2, 2018
    Report Date
    October 24, 2018
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: ORVIN K RELATION OF LEFT VENTRICULAR FRACTIONAL SHORTENING TO NEED FOR PERMANENT PACEMAKER AFTER TRANSCATHETER AORTICVALVE IMPLANTATION. AM J CARDIOL. 2018 SEP 1;122(5):833-837. DOI: 10.1016/J.AMJCARD.2018.05.029. EPUB 2018 JUN 2. 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. WITHOUT RETURN OF THE PRODUCT NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATIONS. 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 RELATION OF LEFT VENTRICULAR FRACTIONAL SHORTENING TO NEED FOR PERMANENT PACEMAKER AFTER TRANSCATHETER AORTIC VALVE IMPLANTATION. ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN MAY 2008 AND NOVEMBER 2015. OVERALL, THE PATIENT POPULATION CONSISTED OF 417 PATIENTS BUT ONLY 407 PATIENTS (PREDOMINANTLY FEMALE, MEAN AGE 82 YEARS) WERE INCLUDED IN THE FINAL ANALYSIS BASED ON THE STUDY INCLUSION CRITERIA. OF THESE, 170 PATIENTS WERE IMPLANTED WITH MEDTRONIC COREVALVE BIOPROSTHESIS AND 22 PATIENTS WERE IMPLANTED WITH EVOLUT-R BIOPROSTHESIS. NO SERIAL NUMBERS WERE PROVIDED. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: COMPLETE HEART BLOCK (CHB), FIRST DEGREE ATRIO-VENTRICULAR (AV) BLOCK, PERMANENT PACEMAKER, LEFT BUNDLE BRANCH BLOCK (LBBB), AND BRADYCARDIA. MULTIPLE MANUFACTURERS WERE NOTED IN THE LITERATURE; BASED ON THE AVAILABLE INFORMATION A DIRECT CORRELATION COULD NOT BE MADE BETWEEN MEDTRONIC PRODUCT AND THE OBSERVED ADVERSE EVENTS. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840366 COREVALVE TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION CRS

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention