BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 8898124 · Received August 15, 2019

    Report

    Report Number
    2025587-2019-02592
    Event Type
    Injury
    Date Received
    August 15, 2019
    Date of Event
    July 2, 2019
    Report Date
    August 15, 2019
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: SHISHIDO K ET AL. NOVEL MECHANISM OF DELAYED CORONARY OBSTRUCTION AFTER TRANSCATHETER AORTIC VALVE REPLACEMENT FOR SEVERE AORTIC STENOSIS: "UPPERCUT PHENOMENON". CARDIOVASC REVASC MED. 2019 JUL 2. PII: S1553-8389(19)30377-X. DOI: 10.1016/J.CARREV.2019.06.017. 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. 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 · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REGARDING A (B)(6)-YEAR-OLD MALE PATIENT WHO PRESENTED WITH DYSPNEA AND SEVERE AORTIC STENOSIS WHO UNDERWENT IMPLANT OF A 29 MM MEDTRONIC EVOLUT R BIOPROSTHETIC VALVE (SERIAL NUMBER NOT PROVIDED). IT WAS NOTED THAT IMMEDIATELY FOLLOWING VALVE IMPLANT, UNDER-EXPANSION WAS OBSERVED BY FLUOROSCOPY. A BALLOON DILATION WITH 23 MM BALLOON (MANUFACTURER NOT IDENTIFIED) WAS PERFORMED AND THE VALVE STENT EXPANSION IMPROVED. POST IMPLANT ANGIOGRAM AND TRANSTHORACIC ECHOCARDIOGRAM BOTH SHOWED MILD PARAVALVULAR LEAKAGE AND ¿NORMAL CONTRAST FLOW INTO BOTH CORONARY ARTERIES.¿ TWO DAYS POST IMPLANT, THE PATIENT COMPLAINED OF CHEST PAIN AND AN ELECTROCARDIOGRAM EXHIBITED COMPLETE LEFT BUNDLE BRANCH BLOCK. EMERGENT CORONARY ANGIOGRAPHY SHOWED SUBTOTAL OCCLUSION IN THE LEFT MAIN TRUNK (LMT) DUE TO SEVERE STENOSIS. INTRAVASCULAR ULTRASOUND WAS PERFORMED FROM THE LEFT CIRCUMFLEX ARTERY AND REVEALED SEVERE STENOSIS IN THE LMT WAS BEING COMPRESSED BY CALCIFICATION FROM THE SINUS OF VALSALVA (SOV). SUBSEQUENTLY, THE PATIENT UNDERWENT EMERGENT PERCUTANEOUS CORONARY INTERVENTION AND HAD 2 DRUG-ELUTING STENTS IMPLANTED ¿STENT-IN-STENT¿ IN THE LMT. IT WAS REPORTED THAT THE DELAYED CORONARY OBSTRUCTION WAS CAUSED BY: ¿CALCIFICATION IN THE SOV AFTER THE EVOLUT R VALVE WAS IMPLANTED MOVED UP TO THE OSTIUM OF THE LMT FROM BELOW THE SOV DUE TO THE SELF-EXPANDING FORCE.¿ NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691601 EVOLUT R TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION EVOLUTR-23

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Required Intervention