BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 14526926 · Received May 27, 2022

    Report

    Report Number
    2025587-2022-01504
    Event Type
    Injury
    Date Received
    May 27, 2022
    Date of Event
    March 3, 2021
    Report Date
    May 27, 2022
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: HOKKEN ET AL. IMPACT OF INTERVENTRICULAR MEMBRANOUS SEPTUM LENGTH ON PACEMAKER NEED WITH DIFFERENT TRANSCATHETER AORTIC VALVE IMPLANTATION SYSTEMS. INT J CARDIOL. 2021 JUN 15;333:152-158. DOI: 10.1016/J.IJCARD.2021.02.080. EPUB 2021 MAR 3. EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT. MEDTRONIC PRODUCTS REFERENCED: EVOLUT R AND EVOLUT PRO. 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 INTERVENTRICULAR MEMBRANOUS SEPTUM LENGTH ON PACEMAKER NEED WITH DIFFERENT TRANSCATHETER AORTIC VALVES. ALL DATA WERE COLLECTED RETROSPECTIVELY FROM A SINGLE CENTER BETWEEN JANUARY 2016 AND MARCH 2020. THE STUDY POPULATION INCLUDED 653 PATIENTS WHO WERE PREDOMINANTLY MALE WITH A MEAN AGE OF 80.6 YEARS. MULTIPLE MANUFACTURER¿S DEVICES WERE IMPLANTED IN THE STUDY POPULATION; 291 WERE IMPLANTED WITH A MEDTRONIC EVOLUT R OR EVOLUT PRO BIOPROSTHETIC VALVE (UNIQUE DEVICE IDENTIFIER NUMBERS NOT PROVIDED). AMONG EVOLUT R PATIENTS ADVERSE EVENTS INCLUDED: ARRHYTHMIA (COMPLETE HEART BLOCK, ATRIAL FIBRILLATION WITH BRADYCARDIA, FIRST-DEGREE AV BLOCK WITH LBBB) REQUIRING PERMANENT PACEMAKER IMPLANT, HIGH MEAN PRESSURE GRADIENTS (40 MMHG) AND HYPERTENSION. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT WAS ASSOCIATED WITH THE ADVERSE EVENT(S). NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2202319 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 Life Threatening| R