BEUDAMED
    FDA Adverse Event Death Summary report: N

    EVOLUT PRO TRANSCATHETER AORTIC VALVE

    MDR report key: 8605531 · Received May 13, 2019

    Report

    Report Number
    2025587-2019-01561
    Event Type
    Death
    Date Received
    May 13, 2019
    Date of Event
    April 16, 2019
    Report Date
    June 13, 2019
    Manufacturer
    HEART VALVES SANTA ANA
    Product Code
    NPT
    UDI-DI
    00763000017835
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE IMPLANT DEPTH OF THE INITIAL VALVE WAS SHALLOW, ABOVE THE NATIVE ANNULUS, AND UPON FULL DEPLOYMENT, THE VALVE DISLODGED HIGH INTO THE SINUSES. A SNARE WAS USED TO ATTEMPT TO MOVE THE INITIAL VALVE ABOVE THE SINOTUBULAR JUNCTION, BUT IT WAS NOT SUCCESSFUL. ONCE THE SECOND VALVE WAS IMPLANTED, THE POSITION OF THE INITIAL VALVE CAUSED THE CALCIFIED NATIVE VALVE LEAFLET TO OCCLUDE THE LEFT CORONARY ARTERY. PER THE PHYSICIAN, THE CAUSE OF DEATH WAS DUE TO A CORONARY ARTERY OCCLUSION FROM THE NATIVE LEAFLET. AN AUTOPSY WAS NOT PERFORMED. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID EVOLUTPRO-29-US; SERIAL (B)(4); USE BY DATE 2020-10-02; UDI (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: THE DEVICE REMAINS IMPLANTED, THEREFORE NO PRODUCT ANALYSIS CAN BE PERFORMED. CONCLUSION: WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE VALVE DISLODGED INTO THE SINUSES. SUBSEQUENTLY, A SECOND VALVE WAS IMPLANTED. IT WAS REPORTED THE PATIENT DIED DURING THE IMPLANT PROCEDURE. THE CAUSE OF DEATH WAS NOT RECEIVED. IT IS UNKNOWN WHETHER AN AUTOPSY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399247 EVOLUT PRO TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT HEART VALVES SANTA ANA EVOLUTPRO-29-US NA 00763000017835

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Death