BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE TRANSCATHETER AORTIC VALVE

    MDR report key: 7005264 · Received November 6, 2017

    Report

    Report Number
    2025587-2017-02042
    Event Type
    Injury
    Date Received
    November 6, 2017
    Date of Event
    March 1, 2015
    Report Date
    November 6, 2017
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: BEKEREDJIAN R ET AL. THE EXTENT OF AORTIC ANNULUS CALCIFICATION IS A PREDICTOR OF POSTPROCEDURAL ECCENTRICITY AND PARAVALVULAR REGURGITATION: A PRE- AND POSTINTERVENTIONAL CARDIAC COMPUTED TOMOGRAPHY ANGIOGRAPHY STUDY. J INVASIVE CARDIOL 2015;27(3):172-180. 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. (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 EXTENT OF ANNULAR CALCIFICATION ON PARAVALVULAR LEAK (PVL). THE STUDY POPULATION INCLUDED 68 PATIENTS (PREDOMINANTLY FEMALE; MEAN AGE 82 YEARS), 46 OF WHICH WERE IMPLANTED WITH MEDTRONIC COREVALVE (SERIAL NUMBERS NOT PROVIDED). AMONG ALL COREVALVE PATIENTS, THREE DEATHS OCCURRED PERI-OPERATIVELY AND DURING FOLLOW-UP. ONE DEATH OCCURRED DUE TO AN ILIAC ARTERY BLEEDING EVENT DURING THE IMPLANT PROCEDURE. NO FURTHER DETAILS WERE PROVIDED. THERE WERE NO DIRECT ALLEGATIONS OF DEVICE INVOLVEMENT, HOWEVER THE DELIVERY CATHETER SYSTEM MAY HAVE CAUSED OR CONTRIBUTED TO THE BLEEDING EVENT. BASED ON THE AVAILABLE INFORMATION, THE OTHER TWO DEATHS FROM SEPTIC SHOCK WERE NOT ATTRIBUTABLE TO MEDTRONIC PRODUCT. AMONG ALL PATIENTS ADVERSE EVENTS INCLUDED: UNEVEN/INCOMPLETE FRAME EXPANSION DUE TO PRE-EXISTING CALCIFICATION, SEVERE PVL, ANNULAR RUPTURE, VALVE DISLOCATION, CORONARY OSTIUM OCCLUSION, BLEEDING, LEFT BUNDLE BRANCH BLOCK, ATRIO-VENTRICULAR BLOCK REQUIRING PERMANENT PACEMAKER IMPLANT, MYOCARDIAL INFARCTION, AND SURGICAL INTERVENTION. MULTIPLE MANUFACTURERS WERE NOTED IN THE LITERATURE; BASED ON THE AVAILABLE INFORMATION A DIRECT CORRELATION COULD NOT BE MADE BETWEEN THE OBSERVED ADVERSE EVENTS AND MEDTRONIC PRODUCT. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783400 COREVALVE TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION CRS

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention