BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 8253890 · Received January 16, 2019

    Report

    Report Number
    2025587-2019-00230
    Event Type
    Injury
    Date Received
    January 16, 2019
    Date of Event
    December 26, 2018
    Report Date
    January 16, 2019
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: BLOOM JP ET AL. EARLY DISTAL MIGRATION OF A SELF-EXPANDING AORTIC VALVE PROSTHESIS CAUSING MYOCARDIAL INFARCTION. ANN THORAC SURG. 2018 DEC 26. PII: S0003-4975(18)31850-2. DOI: 10.1016/J.ATHORACSUR.2018.11.050. [EPUB AHEAD OF PRINT] 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 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 A (B)(6) FEMALE PATIENT WITH SEVERE SYMPTOMATIC TRICUSPID AORTIC STENOSIS WHO UNDERWENT TRANSCATHETER AORTIC VALVE REPLACEMENT WITH THE IMPLANT OF A 26 MM MEDTRONIC EVOLUT R BIOPROSTHETIC VALVE (SERIAL NUMBER NOT PROVIDED). IT WAS REPORTED THAT AT THE TIME OF IMPLANT THE VALVE APPEARED WELL-SEATED WITH ONLY A SMALL PARAVALVULAR LEAK. FOLLOWING 32 DAYS AFTER THE PROCEDURE, THE PATIENT PRESENTED WITH BACK PAIN. ELECTROCARDIOGRAM SHOWED AN ST-ELEVATION MYOCARDIAL INFARCTION WITH TRANSMURAL ISCHEMIA IN THE POSTERIOR DISTRIBUTION AND SUBENDOCARDIAL ISCHEMIA IN THE APICAL AND ANTEROLATERAL REGIONS. AN URGENT CORONARY ANGIOGRAM WAS UNSUCCESSFUL AS NEITHER OF THE CORONARY OSTIA COULD BE ENGAGED BY THE CATHETER. SUPRAVALVULAR AORTOGRAM, COMPUTED TOMOGRAPHY, AND TRANSTHORACIC ECHOCARDIOGRAM ALL SHOWED THAT THE CORONARY OSTIA CAME OFF PROXIMAL TO THE DISTAL SKIRT OF THE VALVE AND HAD PARTIALLY LIMITED FLOW, INDICATING THAT THE VALVE HAD MIGRATED LATERALLY. THE PATIENT¿S CHEST PAIN INITIALLY RESOLVED, BUT ON RECURRENCE WAS UNRESPONSIVE TO MEDICATIONS. SUBSEQUENTLY, THE VALVE WAS SURGICALLY REMOVED AND REPLACED WITH A 21 MM NON-MEDTRONIC BIOPROSTHETIC VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44747 EVOLUT R TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION EVOLUTR-23

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention