BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE TRANSCATHETER AORTIC VALVE

    MDR report key: 8128676 · Received December 4, 2018

    Report

    Report Number
    2025587-2018-03287
    Event Type
    Injury
    Date Received
    December 4, 2018
    Date of Event
    November 7, 2017
    Report Date
    December 4, 2018
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: CZERWINSKA-JELONKIEWICZ THE ROLE OF PLATELET REACTIVITY ASSESSMENT IN DUAL ANTIPLATELET PROPHYLAXIS AFTER TRANSCATHETER AORTIC VALVE IMPLANTATION. CARDIOVASC DIS. 2018 APR;111(4):233-245. DOI: 10.1016/J.ACVD.2017.06.002. EPUB 2017 NOV 7. EARLIEST DATE OF PUBLISH USED FOR EVENT DATE. 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 THE ROLE OF PLATELET REACTIVITY ASSESSMENT IN DUAL ANTIPLATELET PROPHYLAXIS AFTER TRANSCATHETER AORTIC VALVE IMPLANTATION. ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN 2012 AND 2014. THE STUDY POPULATION INCLUDED 100 PATIENTS (PREDOMINANTLY FEMALE, MEAN AGE 79 YEARS), 46 OF WHICH WERE IMPLANTED WITH MEDTRONIC COREVALVE BIOPROSTHESIS. NO SERIAL NUMBERS WERE PROVIDED. AMONG ALL PATIENTS, 4 IN-HOSPITAL DEATHS WERE REPORTED DUE TO UNSPECIFIED REASONS. MULTIPLE MANUFACTURES WERE NOTED IN THE LITERATURE; BASED ON THE AVAILABLE INFORMATION, MEDTRONIC PRODUCT DID NOT CAUSE OR CONTRIBUTE THESE DEATHS. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: MAJOR BLEEDING COMPLICATIONS (N=30), VASCULAR COMPLICATIONS (N=27), THROMBOEMBOLIC EVEN TS (N=7), STROKE (N=4), EMBOLIZATIONS (N=2), BIOPROSTHESIS THROMBOSIS (N=1). MULTIPLE MANUFACTURERS WERE NOTED IN THE LITERATURE; BASED ON THE AVAILABLE INFORMATION A DIRECT CORRELATION COULD NOT BE MADE BETWEEN MEDTRONIC PRODUCT AND THE OBSERVED ADVERSE EVENTS. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    968887 COREVALVE TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION CRS

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention