BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 7158329 · Received January 2, 2018

    Report

    Report Number
    2025587-2018-00007
    Event Type
    Injury
    Date Received
    January 2, 2018
    Date of Event
    September 13, 2017
    Report Date
    January 2, 2018
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: SEEGER, J. MD ET AL. CEREBRAL EMBOLIC PROTECTION DURING TRANSCATHETER AORTIC VALVE REPLACEMENT SIGNIFICANTLY REDUCES DEATH AND STROKE COMPARED WITH UNPROTECTED PROCEDURES. JACC: CARDIOVASCULAR INTERVENTIONS (2017) NOV 27;10(22):2297-2303 DOI 10.1016/J.JC IN.2017.06.037. EARLIEST DATE OF E-PUBLISH/PUBLISH USED FOR EVENT DATE . NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION, IT CANNOT BE DETERMINED WHETHER THIS EVENT HAS BEEN PREVIOUSLY REPORTED. (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 REVIEW REGARDING OUTCOMES AFTER THE USE OF CEREBRAL EMBOLIC PROTECTION DURING TRANSCATHETER AORTIC VALVE REPLACEMENT. ALL DATA WERE COLLECTED BETWEEN 2014 AND 2016. THE STUDY POPULATION INCLUDED 802 PATIENTS, 25 OF WHICH WERE IMPLANTED WITH A MEDTRONIC EVOLUTR TRANSCATHETER BIOPROSTHETIC AORTIC VALVE. SERIAL NUMBERS WERE NOT PROVIDED. THE STUDY POPULATION WAS PREDOMINANTLY FEMALE; MEAN AGE 80 YEARS. AMONG ALL PATIENTS ADVERSE EVENTS INCLUDED: DISABLING AND NON DISABLING CEREBRAL VASCULAR ACCIDENT (CVA), CORONARY OBSTRUCTION, ANNULAR RUPTURE, VASCULAR COMPLICATION AND BLOOD LOSS. BASED ON THE AVAILABLE INFORMATION, THESE EVENTS MAY HAVE BEEN ATTRIBUTED TO A MEDTRONIC PRODUCT. HOWEVER AS MULTIPLE MANUFACTURERS WERE NOTED IN THE LITERATURE, A DIRECT CORRELATION COULD NOT BE MADE BETWEEN THE OBSERVED ADVERSE EVENTS AND THE MEDTRONIC PRODUCT. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700 EVOLUT R TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION EVOLUTR-23

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention