BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE 31MM AORTIC VALVE

    MDR report key: 4201627 · Received October 27, 2014

    Report

    Report Number
    2025587-2014-00794
    Event Type
    Injury
    Date Received
    October 27, 2014
    Date of Event
    September 30, 2014
    Report Date
    June 16, 2015
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: POTENTIAL FACTORS THAT CAN INFLUENCE A DISLODGED VALVE INCLUDE TENSION APPLIED ON THE DELIVERY CATHETER SYSTEM DURING POSITIONING, CALCIFICATION LEVELS IN THE NATIVE VESSEL AND THE COMPLIANCE OF THE AORTA AND NATIVE VESSELS. DISLODGED COMPLAINTS ARE TYPICALLY NOT RELATED TO A DEVICE MALFUNCTION. A CONCLUSIVE CAUSE OF THE DISLODGEMENT COULD NOT BE DETERMINED FROM THE LIMITED INFORMATION AVAILABLE.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT REMAINS IMPLANTED AND THEREFORE HAS NOT BEEN RETURNED TO MEDTRONIC. A SUPPLEMENTAL REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETED. (B)(4)

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT DURING THE ATTEMPTED IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE VALVE DISLODGED FROM THE TARGETED POSITION WHILE STILL ATTACHED TO THE DELIVERY CATHETER SYSTEM (DCS). THE VALVE WAS FULLY DEPLOYED IN THE DESCENDING AORTA ABOVE THE ILIAC BIFURCATION. A SECOND VALVE WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681285 COREVALVE 31MM AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION MCS-P3-31-AOA

    Patients

    Seq Age Sex Outcome Treatment
    1 00089 YR Required Intervention