BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 14900329 · Received July 3, 2022

    Report

    Report Number
    2025587-2022-01831
    Event Type
    Injury
    Date Received
    July 3, 2022
    Date of Event
    May 18, 2021
    Report Date
    July 3, 2022
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: KOBARI Y.; ET AL. ASPIRIN VERSUS CLOPIDOGREL AS SINGLE ANTITHROMBOTIC THERAPY AFTER TRANSCATHETER AORTIC VALVE REPLACEMENT: INSIGHT FROM THE OCEAN-TAVI REGISTRY. CIRC CARDIOVASC INTERV. 2021 MAY;14(5):E010097. DOI: 10.1161/CIRCINTERVENTIONS.120.010097. PMID: 34003663. EPUB 2021 MAY 18. EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT. MEDTRONIC PRODUCTS REFERENCED: COREVALVE, 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 VIA LITERATURE REGARDING OPTIMAL ANTI-PLATELET THERAPY FOLLOWING TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR). ALL DATA WERE COLLECTED FROM A JAPANESE MULTI-CENTER CLINICAL REGISTRY BETWEEN OCTOBER 2013 AND MAY 2017. THE STUDY POPULATION INCLUDED 829 PATIENTS WHO WERE PREDOMINANTLY FEMALE WITH A MEAN AGE OF 85 YEARS. MULTIPLE MANUFACTURER¿S DEVICES WERE IMPLANTED IN THE STUDY POPULATION. AMONG ALL PATIENTS 143 WERE IMPLANTED WITH MEDTRONIC COREVALVE BIOPROSTHETIC VALVES AND 80 WERE IMPLANTED WITH MEDTRONIC EVOLUT R BIOPROSTHETIC VALVES (UNIQUE DEVICE IDENTIFIER NUMBERS NOT PROVIDED). AMONG ALL PATIENTS, 35 DEATHS OCCURRED DURING THE POST-TAVR FOLLOW-UP PERIOD. CAUSES INCLUDED HEART FAILURE, HEMORRHAGIC/ISCHEMIC STROKES, INFECTIOUS ENDOCARDITIS AND SUDDEN CARDIAC DEATH. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT MAY HAVE BEEN ASSOCIATED WITH THE DEATHS. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: LIFE-THREATENING BLEEDING, GASTROINTESTINAL BLEEDING AND STROKES. 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
    1609449 MEDTRONIC TRANSCATHETER VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION MDT-TRANS VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Female Life Threatening