BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2940516 · Received December 20, 2012

    Report

    Report Number
    2017233-2012-00856
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    November 27, 2012
    Report Date
    November 27, 2012
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MFG RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. THE GORE EXCLUDER AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU) WARNS AGAINST CONTINUING TO WITHDRAW THE DELIVERY CATHETER IF RESISTANCE IS FELT DURING REMOVAL THOUGH 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.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PT WAS IMPLANTED WITH A GORE EXCLUDER AAA ENDOPROSTHESIS TO TREAT AN ABDOMINAL AORTIC ANEURYSM. AFTER THE TRUNK-IPSILATERAL LEG COMPONENT (RMT231416 / 10450465) WAS FULLY DEPLOYED, THE PHYSICIAN FELT RESISTANCE WHILE WITHDRAWING THE DELIVERY CATHETER BACK ACROSS THE LUNDERQUIST GUIDE WIRE. THE PHYSICIAN STATED THERE MAY HAVE BEEN A BEND IN THE WIRE. THE PHYSICIAN WAS ABLE TO WITHDRAW THE DELIVERY CATHETER FROM THE SHEATH, AND REMOVED IT FROM THE PT. AS THE PHYSICIAN CONTINUED TO MOVE THE DELIVERY CATHETER ALONG THE GUIDEWIRE, WHICH WAS OUTSIDE THE PT, THERE WAS STILL RESISTANCE, AND THE CATHETER TIP WAS PULLED OFF. THE CATHETER SHAFT AND CATHETER TIP WERE EVENTUALLY REMOVED FROM THE GUIDEWIRE. THE PROCEDURE WAS COMPLETED AS PLANNED WITHOUT ANY FURTHER COMPLICATIONS. THE PT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER AAA ENDOPROSTHESIS MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 10450465

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR