BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 3771919 · Received April 25, 2014

    Report

    Report Number
    3007284313-2014-00038
    Event Type
    Malfunction
    Date Received
    April 25, 2014
    Date of Event
    April 7, 2014
    Report Date
    June 3, 2014
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE EVALUATION SHOWED THE FOLLOWING: THE LEADING OLIVE WAS SEPARATED FROM THE LEADING END OF THE DELIVERY CATHETER. THERE WAS NO EVIDENCE OF A BOND FOR THE LEADING OLIVE TO THE DELIVERY CATHETER ON THE POLYIMIDE GUIDE WIRE LUMEN OR INSIDE THE LEADING OLIVE. THE FINDINGS FROM THE EVALUATION ARE CONSISTENT WITH THE PHYSICIAN'S OBSERVATIONS. THE ROOT CAUSE FOR THE LEADING OLIVE SEPARATION IS DUE TO A LACK OF BONDING BETWEEN THE LEADING OLIVE AND THE DELIVERY CATHETER.

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE USING THE GORE® EXCLUDER® AAA ENDOPROSTHESIS TO REPAIR AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING REMOVAL OF THE DELIVERY CATHETER OF THE AORTIC EXTENDER COMPONENT, THE LEADING OLIVE WAS SEPARATED AT THE VALVE OF THE GORE® DRYSEAL SHEATH WITH HYDROPHILIC COATING. AS THE SEPARATED LEADING OLIVE WAS WITHIN THE SHEATH IT WAS REMOVED ALONG WITH THE SHEATH FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO OTHER REPORTED ISSUE. THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251566 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 12287787

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR DSL1828J/12076325