BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 7866213 · Received September 11, 2018

    Report

    Report Number
    2025587-2018-02399
    Event Type
    Injury
    Date Received
    September 11, 2018
    Date of Event
    August 6, 2018
    Report Date
    September 11, 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: KANEKO H PREDICTORS OF PERMANENT PACEMAKER IMPLANTATION AFTER TRANSCATHETER AORTIC VALVE IMPLANTATION FOR AORTIC STENOSIS USING MEDTRONIC NEW GENERATION SELF-EXPANDING COREVALVE EVOLUT R HEART VESSELS (2018). HTTPS://DOI.ORG/10.1007/S00380-018-1236-Z EARLIEST DATE OF PUBLISH USED FOR EVENT DATE [AND DEATH DATE [PH5] ].   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. 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 PREDICTORS OF PERMANENT PACEMAKER IMPLANTATION AFTER TRANSCATHETER AORTIC VALVE IMPLANTATION FOR AORTIC STENOSIS USING MEDTRONIC NEW GENERATION SELF-EXPANDING COREVALVE EVOLUT R. ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN FEBRUARY 2015 AND APRIL 2017. OVERALL, THE PATIENT POPULATION CONSISTED OF 114 PATIENTS (PREDOMINANTLY FEMALE; MEAN AGE 83 YEARS), ALL OF THEM WERE IMPLANTED WITH MEDTRONIC EVOLUT R BIOPROSTHESIS. SEVENTEEN PATIENTS WHO HAD A PREPROCEDURAL PERMANENT PACEMAKER IMPLANTATION, 1 PATIENT WHO REQUIRED NON-MEDTRONIC VALVE IMPLANTATION DUE TO THE DISLOCATION OF THE INITIAL COREVALVE EVOLUT R IMPLANTATION, AND 4 PATIENTS WHO DIED DURING THE HOSPITAL ADMISSION AFTER TAVI [DUE TO MYOCARDIAL INFARCTION (2 PATIENTS), CARDIAC TAMPONADE, AND PNEUMONIA] WERE EXCLUDED. THUS, THE FINAL STUDY POPULATION COMPRISED OF ONLY 92 PATIENTS WHO WERE IMPLANTED WITH 23 MM, N=1; 26 MM N=19; 29 MM, N= 56, AND 34 MM, N= 16 MEDTRONIC EVOLUT R BIOPROSTHESIS. THE SERIAL NUMBERS WERE NOT PROVIDED. AMONG ALL PATIENTS 4 PATIENTS DIED DURING THE HOSPITAL ADMISSION AFTER IMPLANTATION DUE TO MYOCARDIAL INFARCTION (2 PATIENTS), CARDIAC TAMPONADE, AND PNEUMONIA. THESE PATIENTS WERE NOT INCLUDED IN THE STUDY POPULATION. BASED ON THE AVAILABLE INFORMATION, MEDTRONIC PRODUCT DID NOT CAUSE OR CONTRIBUTE THESE DEATHS. AMONG ALL PATIENTS ADVERSE EVENTS INCLUDED: MODERATE PARAVALVULAR LEAK (PVL), PERMANENT PACEMAKER IMPLANTATION, 3RD DEGREE ATRIO-VENTRICULAR (AV) BLOCK, ATRIAL FIBRILLATION, RIGHT BUNDLE BRANCH BLOCK (RBBB). BASED ON THE AVAILABLE INFORMATION, MEDTRONIC PRODUCT MAY HAVE CAUSED OR CONTRIBUTED TO THESE ADVERSE EVENTS. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE PROBLEMS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707392 EVOLUT R TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION EVOLUTR-23

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention