BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 8103103 · Received November 26, 2018

    Report

    Report Number
    2025587-2018-03185
    Event Type
    Injury
    Date Received
    November 26, 2018
    Date of Event
    October 23, 2018
    Report Date
    November 26, 2018
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: KIBLER M ET AL. PRIMARY HEMOSTATIC DISORDERS AND LATE MAJOR BLEEDING AFTER TRANSCATHETER AORTIC VALVE REPLACEMENT. J AM COLL CARDIOL. 2018 OCT 30; 72 (18): 2139-2148. DOI: 10.1016/J.JACC.2018.08.2143. EPUB 2018 OCT 23. 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 THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATIONS. (B)(4). 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 IMPACT OF ONGOING PRIMARY HEMOSTASIS DISORDERS ON LATE MAJOR OR LIFE-THREATENING BLEEDING COMPLICATIONS FOLLOWING TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR). BLEEDINGS WERE ASSESSED ACCORDING TO THE DEFINITIONS PROVIDED BY THE VALVE ACADEMIC RESEARCH CONSORTIUM-2 (VARC-2) CRITERIA. ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN NOVEMBER 2012 AND JUNE 2017. THE STUDY POPULATION INCLUDED 397 PATIENTS (PREDOMINANTLY FEMALE; MEAN AGE 84 YEARS), AN UNDISCLOSED NUMBER OF WHICH WERE IMPLANTED WITH EITHER A MEDTRONIC COREVALVE BIOPROSTHETIC VALVE OR A MEDTRONIC EVOLUT R BIOPROSTHETIC VALVE. NO SERIAL NUMBERS WERE PROVIDED. AMONG ALL PATIENTS, 50 DEATHS OCCURRED DURING THE STUDY PERIOD. OF THOSE, 20 WERE FROM CARDIOVASCULAR DISEASE. MULTIPLE MANUFACTURERS WERE NOTED IN THE LITERATURE; BASED ON THE AVAILABLE INFORMATION, MEDTRONIC PRODUCT DID NOT CAUSE OR CONTRIBUTE TO THESE DEATHS. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: ONE CASE OF CARDIAC TAMPONADE AFTER RIGHT VENTRICULAR RUPTURE FOLLOWING PACEMAKER IMPLANTATION 2 MONTHS AFTER TAVR, 16 CASES OF ISCHEMIC STROKE, SIGNIFICANT PARAVALVULAR LEAK, 7 CASES OF LIFE-THREATENING BLEEDING AND 35 CASES OF MAJOR BLEEDING. 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
    942937 EVOLUT R TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION EVOLUTR-23

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention