BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 13480449 · Received February 8, 2022

    Report

    Report Number
    2025587-2022-00377
    Event Type
    Injury
    Date Received
    February 8, 2022
    Date of Event
    October 11, 2021
    Report Date
    February 8, 2022
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: MONTALTO C, ET AL. OUTCOMES AFTER TRANSCATHETER AORTIC VALVE REPLACEMENT IN BICUSPID VERSUS TRICUSPID ANATOMY: A SYSTEMATIC REVIEW AND META-ANALYSIS. JACC CARDIOVASC INTERV. 2021 OCT 11;14(19):2144-2155. DOI: 10.1016/J.JCIN.2021.07.052. EARLIEST DATE OF PUBLISH USED FOR DATE OF EVENT. MEDTRONIC PRODUCTS REFERENCED: COREVALVE (PMA# P130021, PRODUCT CODE NPT), EVOLUT R (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 FROM A LITERATURE ARTICLE REGARDING THE OUTCOMES OF TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) IN BICUSPID AORTIC VALVE (BAV) VERSUS TRICUSPID AORTIC VALVE (TAV) ANATOMY. ALL DATA WAS COLLECTED FROM A META-ANALYSIS REVIEW OF 17 STUDIES PUBLISHED BETWEEN 2013 AND 2020. A TOTAL OF 181,433 PATIENTS WERE INCLUDED IN THE STUDY POPULATION (PREDOMINANTLY MALE, MEAN AGE 78.1 YEARS), COMPRISING 174,764 WITH TAV AND 6,669 WITH BAV. AN UNDISCLOSED NUMBER OF THESE PATIENTS WERE IMPLANTED WITH A MEDTRONIC COREVALVE OR EVOLUT R TRANSCATHETER VALVE. NO UNIQUE DEVICE IDENTIFIER NUMBERS WERE PROVIDED. THE ONE-YEAR MORTALITY RATES WERE 91.3% AND 90.8% IN BAV AND TAV PATIENTS, RESPECTIVELY. NO STATEMENT WAS MADE SUGGESTING A CAUSAL OR CONTRIBUTORY RELATIONSHIP BETWEEN MEDTRONIC PRODUCT AND THE DEATHS. NON-DEATH ADVERSE EVENTS INCLUDED: MAJOR VASCULAR COMPLICATIONS, MYOCARDIAL INFARCTION, STROKE/TRANSIENT ISCHEMIC ATTACK, MAJOR OR L IFE-THREATENING BLEEDING, ANNULAR RUPTURE, CORONARY OCCLUSION, VALVE EMBOLIZATION (DISLODGEMENT), CONVERSION TO SURGERY, NEED FOR SECOND VALVE IMPLANTATION, NEW PERMANENT PACEMAKER IMPLANTATION, AND MODERATE TO SEVERE PARAVALVULAR LEAK. MEDTRONIC PRODUCT MAY HAVE BEEN ASSOCIATED WITH THESE ADVERSE EVENTS. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    903985 MEDTRONIC TRANSCATHETER VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION MDT-TRANS VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Life Threatening| R