BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 12080603 · Received June 28, 2021

    Report

    Report Number
    2025587-2021-02016
    Event Type
    Injury
    Date Received
    June 28, 2021
    Date of Event
    March 17, 2020
    Report Date
    June 28, 2021
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: LIM S., ET AL. KOREAN CIRC J. 2020 JUL;50(7):572-582. ENGLISH. PUBLISHED ONLINE MAR 17, 2020. PMID: (B)(4). HTTPS://DOI. ORG/10.4070/KCJ.2019.0385 EARLIEST DATE OF PUBLISH 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 · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REGARDING AORTIC ROOT SINUS OF VALSALVA THROMBUS FORMATION DISCOVERED BY COMPUTERIZED TOMOGRAPHY (CT) SCAN AFTER TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR). ALL DATA WERE RETROSPECTIVELY COLLECTED FROM A SINGLE CENTER BETWEEN MARCH 2011 AND AUGUST 2019. THE STUDY POPULATION INCLUDED NINE PATIENTS (PREDOMINANTLY FEMALE, MEAN AGE 81 YEARS), EIGHT OF WHICH WERE IMPLANTED WITH MEDTRONIC COREVALVE BIOPROSTHETIC VALVES (UNIQUE DEVICE IDENTIFIER NUMBERS NOT PROVIDED). SEVEN OF THESE PATIENTS THEN UNDERWENT IMMEDIATE VALVE-IN-VALVE TRANSCATHETER IMPLANTATION WITH ANOTHER MEDTRONIC COREVALVE BIOPROSTHETIC VALVE AND ONE RECEIVED A MEDTRONIC EVOLUT R BIOPROSTHETIC VALVE (UNIQUE DEVICE IDENTIFIER NUMBERS NOT PROVIDED). AMONG ALL PATIENTS, ONE DEATH OCCURRED, APPROXIMATELY 1.5 YEARS AFTER DISCOVERY OF THEIR SINUS OF VALSALVA THROMBOSIS, HOWEVER IT WAS NOTED THE CAUSE OF DEATH WAS UNKNOWN AND THE PATIENT'S IMPLANTED VALVE MODEL WAS NOT REFERENCED. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT WAS NOT DIRECTLY ASSOCIATED WITH THE DEATH. AMONG ALL MEDTRONIC COREVALVE AND EVOLUT R PATIENTS, ADVERSE EVENTS INCLUDED: NEED FOR VALVE-IN-VALVE REPLACEMENT DUE TO INAPPROPRIATE INITIAL VALVE IMPLANTATION, LEAFLET THROMBOSES, SINUS OF VALSALVA THROMBOSES, EMBOLIC CEREBROVASCULAR ACCIDENTS AND TRIVIAL-TO-MODERATE PARAVALVULAR LEAK. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT WAS DIRECTLY 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
    977646 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 Life Threatening| R