BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 12565100 · Received October 1, 2021

    Report

    Report Number
    2025587-2021-02942
    Event Type
    Injury
    Date Received
    October 1, 2021
    Date of Event
    July 26, 2021
    Report Date
    October 1, 2021
    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

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: VENTURI G, ET AL. CONTRAST-INDUCED NEPHROPATHY IN PATIENTS UNDERGOING STAGED VERSUS CONCOMITANT TRANSCATHETER AORTIC VALVE IMPLANTATION AND CORONARY PROCEDURES. J AM HEART ASSOC. 2021 AUG 3;10(15):E020599. DOI: 10.1161/JAHA.120.020599. EPUB 2021 JUL 26. 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), 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 · 1

    MEDTRONIC RECEIVED INFORMATION FROM A LITERATURE ARTICLE REGARDING THE INCIDENCE OF CONTRAST-INDUCED ACUTE KIDNEY INJURY IN PATIENTS UNDERGOING STAGED OR CONCOMITANT CORONARY PROCEDURES AND TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI). ALL DATA WAS RETROSPECTIVELY ANALYZED FROM A SINGLE CENTER BETWEEN APRIL 2012 AND OCTOBER 2020. OF THE 339 PATIENTS INCLUDED IN THE STUDY POPULATION (PREDOMINANTLY FEMALE, MEAN AGE 82.7 YEARS), APPROXIMATELY 89 UNDERWENT TAVI WITH A MEDTRONIC TRANSCATHETER VALVE: COREVALVE, EVOLUT R, OR EVOLUT PRO. NO UNIQUE DEVICE IDENTIFIER NUMBERS WERE PROVIDED. AMONG ALL PATIENTS, FIVE DEATHS OCCURRED WITHIN THIRTY DAYS OF TAVI. NO STATEMENT WAS MADE SUGGESTING A CAUSAL OR CONTRIBUTORY RELATIONSHIP BETWEEN MEDTRONIC PRODUCT AND THE DEATHS. AMONG ALL PATIENTS, ADVERSE EVENTS THAT OCCURRED WITHIN THIRTY DAYS OF TAVI INCLUDED: MAJOR BLEEDING, VASCULAR COMPLICATIONS, STROKE, CORONARY OBSTRUCTION, AND NEED FOR REPEAT PROCEDURE. 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
    1457146 MEDTRONIC TRANSCATHETER VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION MDT-TRANS VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| L| R