BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 3710932 · Received March 31, 2014

    Report

    Report Number
    2017233-2014-00158
    Event Type
    Malfunction
    Date Received
    March 31, 2014
    Date of Event
    January 17, 2014
    Report Date
    April 1, 2014
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. THE DEVICE WAS RETURNED TO GORE HISTOLOGY FOR A ENGINEERING EVALUATION. PER THE EVALUATION THE CATHETER REMAINED INSIDE THE INTRODUCER SHEATH. THE TRAILING OLIVE WAS DAMAGED, DETACHED, AND PUSHED INTO THE LEADING OLIVE. THE LEADING OLIVE TIP WAS DEFORMED. THE INTRODUCER SHEATH TIP WAS DAMAGED. THE EVALUATION OF THE RETURNED DEVICE IS CONSISTENT WITH THE PHYSICIAN¿S OBSERVATIONS. THE ROOT CAUSE(S) FOR THE TRAILING OLIVE BECOMING DETACHED COULD NOT BE DETERMINED WITH THE CURRENTLY AVAILABLE INFORMATION. PER THE WARNINGS AND PRECAUTIONS SECTION OF THE IFU STATES, ¿DO NOT CONTINUE TO WITHDRAW THE DELIVERY CATHETER IF RESISTANCE IS FELT DURING REMOVAL THROUGH THE INTRODUCER SHEATH. FORCIBLY WITHDRAWING THE DELIVERY CATHETER THROUGH THE INTRODUCER SHEATH WHEN RESISTANCE IS ENCOUNTERED HAS RESULTED IN ADVERSE EVENTS INCLUDING CATHETER SEPARATION AND REINTERVENTION.¿ CONTINUED WITHDRAWAL OF THE CATHETER AGAINST RESISTANCE MAY HAVE CONTRIBUTED TO THE CATHETER DAMAGE AND THE BROKEN BOND BETWEEN THE TRAILING OLIVE AND THE CATHETER SHAFT.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS TO TREAT AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT WHILE THE PHYSICIAN WAS WITHDRAWING THE DELIVERY CATHETER OF THE PXC141000/9051302 THE DISTAL END GOT CAUGHT ON THE 12FR DRYSEAL SHEATH. THE PHYSICIAN WAS ABLE TO REMOVE THE DELIVERY CATHETER WHILE IT WAS INSIDE THE DRYSEAL SHEATH. A NEW DRYSEAL SHEATH 12 FR WAS USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE CONCLUDED WITH NO FURTHER EVENT. THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191484 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 9051302

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention