BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT PRO TRANSCATHETER AORTIC VALVE

    MDR report key: 11055161 · Received December 22, 2020

    Report

    Report Number
    2025587-2020-03901
    Event Type
    Injury
    Date Received
    December 22, 2020
    Date of Event
    June 30, 2020
    Report Date
    December 22, 2020
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: THE VALVE REMAINS IMPLANTED THEREFORE NO PRODUCT ANALYSIS CAN BE PERFORMED. CONCLUSION: WITHOUT 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 FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE A PSEUDOANEURYSM IN THE VALSALVA SINUS ON THE RIGHT CORONARY CUSP (RCC) SIDE WAS OBSERVED VIA COMPUTED TOMOGRAPHY (CT) ANGIOGRAPHY. AN ANNULUS RUPTURE WAS INDICATED. HEMODYNAMICS WERE MAINTAINED BY RCC PERFORATION AND CARDIAC DRAINAGE. THE PATIENT WAS STARTED ON ANTIPLATELET THERAPY AND TRANSFERRED TO ANOTHER HOSPITAL FOR REHABILITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1522421 EVOLUT PRO TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION EVOLUTPRO-26

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention