BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREO ABDOMINAL STENT-GRAFT SYSTEM

    MDR report key: 10971720 · Received December 8, 2020

    Report

    Report Number
    2247858-2020-00064
    Event Type
    Malfunction
    Date Received
    December 8, 2020
    Date of Event
    November 12, 2020
    Report Date
    February 16, 2021
    Manufacturer
    BOLTON MEDICAL, INC.
    Product Code
    MIH
    PMA / PMN Number
    P190015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    POST DEPLOYMENT OF THE 28X100 GRAFT AND UPON RETRACTION OF THE INNER DELIVERY SYSTEM FROM THE LEAVE BEHIND SHEATH, THE INNER SYSTEM GOT CAUGHT WITHIN THE DOUBLE VALVE MECHANISMS. DR. (B)(6) WAS NOT ABLE TO CLEAR IT THROUGH THE PASSIVE/ACTIVE VALVES, SO HE MADE THE DECISION TO RETRACT THE ENTIRE SYSTEM AND REPLACE IT WITH A COOK 16FR SHEATH. PATIENT OUTCOME - "NO CLINICAL SEQUELA. PATIENT DID FINE AND WAS DISCHARGED POST OP DAY 2."

    Description of Event or Problem · 1

    POST DEPLOYMENT OF THE 28X100 GRAFT AND UPON RETRACTION OF THE INNER DELIVERY SYSTEM FROM THE LEAVE BEHIND SHEATH, THE INNER SYSTEM GOT CAUGHT WITHIN THE DOUBLE VALVE MECHANISMS. DR. (B)(6) WAS NOT ABLE TO CLEAR IT THROUGH THE PASSIVE/ACTIVE VALVES, SO HE MADE THE DECISION TO RETRACT THE ENTIRE SYSTEM AND REPLACE IT WITH A COOK 16FR SHEATH. PATIENT OUTCOME - "NO CLINICAL SEQUELA. PATIENT DID FINE AND WAS DISCHARGED POST OP DAY 2."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1429073 TREO ABDOMINAL STENT-GRAFT SYSTEM STENT, ENDOVASCULAR GRAFT, AORTIC MIH BOLTON MEDICAL, INC. 2009080370

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR