BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 13196919 · Received January 7, 2022

    Report

    Report Number
    2025587-2022-00051
    Event Type
    Injury
    Date Received
    January 7, 2022
    Date of Event
    September 1, 2021
    Report Date
    January 7, 2022
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: POSTALIAN A, ET AL. ¿SIMPLE¿ TRANSCATHETER AORTIC VALVE REPLACEMENT WITH CONSCIOUS SEDATION: SAFETY AND EFFECTIVENESS IN R EAL-WORLD PRACTICE. TEX HEART INST J. 2021 SEP 1;48(4):E207528. DOI: 10.10453/THIJ-20-7528. EARLIEST DATE OF PUBLISH USED FOR DATE OF EVENT. MEDTRONIC PRODUCTS REFERENCED: COREVALVE FAMILY. DURING THE STUDY PERIOD, THE FOLLOWING COREVALVE FAMILY VALVES WERE FDA APPROVED AND MAY HAVE BEEN IMPLANTED IN THE PATIENT POPULATION: COREVALVE (PMA# P130021, PRODUCT CODE NPT), EVOLUT R (PMA# P130021, PRODUCT CODE NPT), EVOLUT PRO (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 · 0

    MEDTRONIC RECEIVED INFORMATION FROM A LITERATURE ARTICLE REGARDING THE SAFETY AND EFFECTIVENESS OF A SIMPLIFIED APPROACH FOR PERFORMING TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR). ALL DATA WAS RETROSPECTIVELY COLLECTED FROM A SINGLE CENTER BETWEEN MARCH 2015 AND FEBRUARY 2020. OF THE 344 PATIENTS INCLUDED IN THE STUDY POPULATION (PREDOMINANTLY MALE, MEAN AGE 78 YEARS), 28 WERE IMPLANTED WITH A TRANSCATHETER VALVE FROM THE MEDTRONIC COREVALVE FAMILY. NO UNIQUE DEVICE IDENTIFIER NUMBERS WERE PROVIDED. AMONG ALL 344 PATIENTS INCLUDED IN THE STUDY POPULATION, 4 ALL-CAUSE DEATHS OCCURRED WITHIN 30 DAYS OF TAVR. NO STATEMENT WAS MADE SUGGESTING A CAUSAL OR CONTRIBUTORY RELATIONSHIP BETWEEN MEDTRONIC PRODUCT AND THE DEATHS. MEDTRONIC TRANSCATHETER VALVES MAY HAVE BEEN ASSOCIATED WITH THE FOLLOWING ADVERSE EVENTS: NEW PERMANENT PACEMAKER IMPLANTATION, STROKE, AND UNSPECIFIED MAJOR VASCULAR COMPLICATIONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    993312 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