BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 14712898 · Received June 16, 2022

    Report

    Report Number
    2025587-2022-01701
    Event Type
    Injury
    Date Received
    June 16, 2022
    Date of Event
    February 1, 2022
    Report Date
    June 16, 2022
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: AKODAD M, ET AL. EARLY TRANSCATHETER HEART VALVE PANNUS LEADING TO CORONARY OBSTRUCTION MANAGED WITH ORTHOTOPIC CHIMNEY STENTING. CJC OPEN. 2022 FEB 1;4(5):509-511. DOI: 10.1016/J.CJCO.2022.01.008. EARLIEST DATE OF PUBLISH USED FOR DATE OF EVENT. 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 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 · 0

    MEDTRONIC RECEIVED INFORMATION FROM A LITERATURE CASE REPORT REGARDING A 78-YEAR-OLD FEMALE PATIENT WHO WAS ADMITTED TO THE HOSPITAL WITH ACUTE CORONARY SYNDROME SIX MONTHS AFTER TRANSCATHETER AORTIC VALVE REPLACEMENT WITH A 26 MM MEDTRONIC EVOLUT R VALVE (UNIQUE DEVICE IDENTIFIER NUMBER NOT PROVIDED). CORONARY ANGIOGRAPHY WAS CHALLENGING, AND ONLY NON-SELECTIVE IMAGES WERE OBTAINED. THE PATIENT WAS TREATED WITH DUAL ANTIPLATELET THERAPY AND THERAPEUTIC ANTICOAGULATION. HOWEVER, DESPITE AGGRESSIVE ANTITHROMBOTIC MANAGEMENT FOR ONE WEEK, THE PATIENT CONTINUED TO DETERIORATE AND WAS EVENTUALLY REFERRED TO THE AUTHORS FACILITY WITH REFRACTORY ANGINA AND ELEVATING TROPONIN LEVELS. AN URGENT CARDIAC COMPUTED TOMOGRAPHY SCAN SHOWED EXTENSIVE PANNUS ON THE EVOLUT R VALVE FRAME, EXPANDING UP TO THE LEVEL OF THE CORONARY ARTERIES AND THE VALVE COMMISSURE POSTS POSITIONED IN FRONT OF BOTH CORONARY ARTERY OSTIA. THROMBUS WAS ALSO IDENTIFIED IN THE SINUSES OF VALSALVA, BECAUSE OF IMPAIRED FLOW CAUSED BY THE TISSUE INGROWTH. CONSIDERING THE CRITICAL PRESENTATION, WITH WORSENING SYMPTOMS AND DYNAMIC ELECTROCARDIOGRAM CHANGES, THE PATIENT WAS REFERRED FOR PERCUTANEOUS CORONARY INTERVENTION TO IMPROVE LEFT MAIN PERFUSION. SUBSEQUENTLY, A DRUG-ELUTING STENT WAS IMPLANTED FROM THE LEFT ANTERIOR DESCENDING ARTERY BACK ACROSS THE EVOLUT R STRUT. DESPITE STENT REINFLATION AT HIGH PRESSURE, A SIGNIFICANT WAIST AT THE LEVEL OF THE EVOLUT R STRUT WAS NOTED, AND THE AUTHORS DECIDED TO IMPLANT A SECOND OVERLAPPING STENT TO IMPROVE RADIAL STRENGTH AT THIS LEVEL WITH AN EXCEL LENT ANGIOGRAPHIC RESULT AND IMMEDIATE RESOLUTION OF CHEST PAIN AND ST DEPRESSION. GIVEN THE RESOLUTION OF SYMPTOMS AND RIGHT CORONARY ARTERY SMALL DIAMETER, THIS AREA WAS MANAGED MEDICALLY. THE PATIENT WAS DISCHARGED UNDER ORAL ANTICOAGULATION AND CLOPIDOGREL. AT SIX-MONTH FOLLOW-UP, THE PATIENT WAS ASYMPTOMATIC. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2312869 EVOLUT R TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION EVOLUTR-26

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Hospitalization| R