BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 7236892 · Received February 2, 2018

    Report

    Report Number
    2025587-2018-00281
    Event Type
    Injury
    Date Received
    February 2, 2018
    Date of Event
    August 9, 2017
    Report Date
    February 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: WON-KEUN, K. MD ET AL. COMPARISON OF OUTCOMES USING BALLOON EXPANDABLE VERSUS SELF EXPANDING TRANSCATHETER PROSTHESES ACCORDING TO THE EXTENT OF AORTIC VALVE CALCIFICATION. CLINICAL RESEARCH IN CARDIOLOLOGY (2017) DEC;106(12):995-1004 DOI 10.1007/S00392-017-1149-3. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION, IT CANNOT BE DETERMINED WHETHER THIS EVENT HAS BEEN PREVIOUSLY REPORTED. 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 IN PATIENTS AORTIC VALVE CALCIFICATION AFTER THE IMPLANT OF A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR). ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN 2011 AND 2017. THE STUDY POPULATION INCLUDED 1,232 PATIENTS, 177 OF WHICH WERE IMPLANTED WITH A COREVALVE AND 15 OF WHICH WERE IMPLANTED WITH AN EVOLUTR. SERIAL NUMBERS WERE NOT PROVIDED. THE STUDY POPULATION THAT INCLUDED SELF-EXPANDABLE TAVR WAS PREDOMINANTLY FEMALE; MEAN AGE 82.3 YEARS. AMONG ALL PATIENTS ADVERSE EVENTS INCLUDED: GREATER THAN MODERATE PARAVALVULAR LEAK (PVL), MALPOSITIONING, DEVICE EMBOLIZATION, THE IMPLANT OF A SECOND VALVE, AORTIC ROOT INJURY, CONVERSION TO SURGERY, CEREBRAL VASCULAR ACCIDENT (CVA), BLEEDING, VASCULAR COMPLICATIONS, PERMANENT PACEMAKER IMPLANT. 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
    81192 EVOLUT R TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION EVOLUTR-23

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention