BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 14607517 · Received June 6, 2022

    Report

    Report Number
    2025587-2022-01582
    Event Type
    Injury
    Date Received
    June 6, 2022
    Date of Event
    May 7, 2021
    Report Date
    June 6, 2022
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: EL-SABAWI B.; ET AL. TEMPORAL INCIDENCE AND PREDICTORS OF HIGH-GRADE ATRIOVENTRICULAR BLOCK AFTER TRANSCATHETER AORTIC VALVE REPLACEMENT. J AM HEART ASSOC. 2021 MAY; 10(10):E020033. DOI: 10.1161/JAHA.120.020033. PMID: 33960210. EPUB 2021 MAY 7. EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT. MEDTRONIC PRODUCTS REFERENCED: COREVALVE, EVOLUT R, EVOLUT PRO (PMA# P130021, PRODUCT CODE: NPT). EARLIEST APPROVED PRODUCT USED FOR PRODUCT CODE AND PMA#. 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 · 0

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REGARDING THE DEVELOPMENT OF HIGH-GRADE ATRIOVENTRICULAR BLOCK (HAVB) AFTER TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR). ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN FEBRUARY 2012 AND JUNE 2019. THE STUDY POPULATION INCLUDED 953 PATIENTS WHO WERE PREDOMINANTLY MALE WITH A MEAN AGE OF 81 YEARS. MULTIPLE MANUFACTURER¿S DEVICES WERE IMPLANTED IN THE STUDY POPULATION. AMONG ALL PATIENTS, 139 PATIENTS WERE IMPLANTED WITH MEDTRONIC SELF-EXPANDING BIOPROSTHETIC VALVES, INCLUDING COREVALVE, EVOLUT R AND EVOLUT PRO MODELS (UNIQUE DEVICE IDENTIFIER NUMBERS NOT PROVIDED). AMONG ALL PATIENTS, EIGHT DEATHS OCCURRED WITHIN 30 DAYS OF TAVR. IT WAS NOTED THAT THREE OF THE DEATHS WERE FROM UNEXPLAINED CAUSES, BUT THE ARTICLE PROVIDED NO FURTHER INFORMATION ON THE CAUSE OF DEATHS FOR THE REMAINING FIVE PATIENTS. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT WAS NOT DIRECTLY ASSOCIATED WITH THE DEATHS. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: NEED TO IMPLANT A SECOND VALVE; LEFT/RIGHT BUNDLE BRANCH BLOCK (LBBB/RBBB), FIRST-DEGREE ATRIOVENTRICULAR (AV) BLOCK, FASCICULAR AV BLOCK AND ATRIAL FIBRILLATION REQUIRING TEMPORARY OR PERMANENT PACEMAKER IMPLANTATION. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT MAY HAVE BEEN ASSOCIATED WITH THE ADVERSE EVENTS. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1319472 MEDTRONIC TRANSCATHETER VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION MDT-TRANS VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male Required Intervention UNKNOWN IPG