BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE TRANSCATHETER AORTIC VALVE

    MDR report key: 11448848 · Received March 9, 2021

    Report

    Report Number
    2025587-2021-00791
    Event Type
    Injury
    Date Received
    March 9, 2021
    Date of Event
    December 1, 2020
    Report Date
    March 9, 2021
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: FAN J ET AL. BRAIN INJURY AFTER TRANSCATHETER REPLACEMENT OF BICUSPID VERSUS TRICUSPID AORTIC VALVES. J AM COLL CARDIOL. 2020 DEC 1;76(22):2579-2590. DOI: 10.1016/J.JACC.2020.09.605. EARLIEST DATE OF PUBLISH USED FOR DATE OF EVENT. 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 NEW CEREBRAL ISCHEMIC LESIONS IN BICUSPID AORTIC VALVE PATIENTS AND TRICUSPID AORTIC VALVE PATIENTS FOLLOWING TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR). ALL DATA WAS COLLECTED FROM A SINGLE CENTER REGISTRY BETWEEN DECEMBER 2016 AND DECEMBER 2019. THE STUDY POPULATION INCLUDED 204 PATIENTS AND WAS PREDOMINANTLY MALE WITH A MEDIAN AGE OF 77 YEARS. AN UNDISCLOSED NUMBER OF THESE PATIENTS WERE IMPLANTED WITH MEDTRONIC COREVALVE TRANSCATHETER VALVES. NO UNIQUE DEVICE IDENTIFIER NUMBERS WERE PROVIDED. THE AUTHORS NOTED THAT ALL PATIENTS RECEIVED BRAIN DIFFUSION-WEIGHTED MAGNETIC RESONANCE IMAGING WITHIN A MEDIAN OF FIVE DAYS AFTER TAVR. AMONG ALL PATIENTS, TWO DEATHS OCCURRED WITHIN THIRTY DAYS AFTER TAVR. MULTIPLE TRANSCATHETER VALVE BRANDS WERE IMPLANTED IN THE STUDY POPULATION. NONE OF THE DEATHS WERE DIRECTLY ASSOCIATED WITH COREVALVE. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: CONVERSION TO SURGICAL AORTIC VALVE REPLACEMENT, SEVERE HYPOTENSION NECESSITATING UNPLANNED CARDIOPULMONARY BYPASS DURING TAVR, NEW CEREBRAL ISCHEMIC LESIONS, STROKE (DISABLING OR NON-DISABLING), NEW PERMANENT PACEMAKER IMPLANTATION, NEW ONSET ATRIAL FIBRILLATION, MODERATE TO SEVERE PARAVALVULAR LEAK, AND UNSPECIFIED VASCULAR COMPLICATIONS. COREVALVE 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
    345433 COREVALVE TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION CRS

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Life Threatening| R| S