BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2071852 · Received April 25, 2011

    Report

    Report Number
    2017233-2011-00210
    Event Type
    Injury
    Date Received
    April 25, 2011
    Date of Event
    April 7, 2011
    Report Date
    April 21, 2011
    Manufacturer
    W.L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MFG PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MFG PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECS.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THIS PT WAS UNDERGOING TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM WITH A GORE EXCLUDER AAA ENDOPROSTHESIS FEATURING C3 DELIVERY SYSTEM TRUNK-IPSILATERAL LEG COMPONENT. IT WAS REPORTED THE DEVICE WAS DEPLOYED DOWN TO THE CONTRALATERAL GATE, AND THE CONSTRAINING MECHANISM WAS REMOVED WITH NO ISSUE. HOWEVER, THE IPSILATERAL LIMB REPORTEDLY DID NOT DEPLOY WHEN THE LAST STEP OF DEPLOYMENT WAS BEING PERFORMED. IT WAS REPORTED THAT THE DEPLOYMENT STRING JUST PULLED OUT, AND IT APPEARED THAT THE CONSTRAINING MECHANISM DID NOT RELEASE AROUND THE IPSILATERAL LIMB. THE PHYSICIAN ATTEMPTED TO OPEN THE IPSILATERAL LIMB BY PULLING THE DEVICE DISTALLY TO GET THE OLIVE OF THE DELIVERY CATHETER TO OPEN THE IPSILATERAL LIMB. HOWEVER, THE IPSILATERAL LIMB STILL WOULD NOT OPEN. AT THIS POINT, THE PHYSICIAN TRIED TO REMOVE THE DELIVERY CATHETER, BUT THE PROXIMAL OLIVE BECAME STUCK ON THE DEVICE. THE PHYSALIN WENT FROM BELOW THE DEVICE WITH A GUIDEWIRE IN ATTEMPT TO BALLOON THE IPSILATERAL LIMB FROM BELOW. THE PHYSICIAN WAS ABLE TO OPEN THE IPSILATERAL LIMB UP TO WHERE THE OLIVE WAS STUCK, BUT THE IPSILATERAL LIMB STILL WOULD NOT FULLY OPEN IN ONE AREA WHERE THERE WAS AN AREA OF STENOSIS. THE PHYSICIAN AGAIN TRIED TO REMOVE THE DELIVERY CATHETER. WHEN IT WAS DETERMINED THAT THE CATHETER COULD NOT BE REMOVED, THE PHYSICIAN REPORTEDLY ELECTED TO CUT THE DELIVERY CATHETER AND LEAVE PART OF IT IN THE ILIAC ARTERY. A FEMORAL-FEMORAL BYPASS WAS THEN PERFORMED, AND THREE AORTIC EXTENDER COMPONENTS WERE IMPLANTED FOR PROXIMAL EXTENSION. FINAL ANGIOGRAPHY SHOWED NO EVIDENCE OF ENDOLEAK, AND 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, INC. WLG425 8228507

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R ARICEPT| CALCIUM| SEROQUEL| SIMVASTATIN| WARFARIN| SYNTHROID| LEXAPRO| METOPROLOL| CITALOPRAM| MAGNESIUM| ZINC| SAW PALMETTO| PROSTATE HEALTH| GLUCOSAMINE CHONDROITIN| TYLENOL| PT MEDICATIONS INCLUDE MVI,| VITAMIN C| POTASSIUM GLUTAMATE| LISINOPRIL