BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH AAA ENDOVASCULAR GRAFT ILLIAC LEG

    MDR report key: 1241765 · Received November 19, 2008

    Report

    Report Number
    1820334-2008-00659
    Event Type
    Injury
    Date Received
    November 19, 2008
    Date of Event
    October 20, 2008
    Report Date
    October 20, 2008
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT EVALUATION- STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    A MALE PT WITH A SUITABLE FORM FOR ENDOVASCULAR THERAPY, BUT A TORTUOUS ARTERY UNDERWENT THE PROCEDURE IN 2008 AS LABELED. IT WAS DIFFICULT TO ADVANCE THE CONTRALATERAL ILIAC LEG DELIVERY SYSTEM. THE PHYSICIAN MANAGED TO REACH THE TARGET SITE AND TRIED TO WITHDRAW THE SHEATH TO RELEASE THE STENT BUT RESISTANCE WAS MET AND FAILED. THE ILIAC LEG DELIVERY SYSTEM WAS REMOVED AND IT WAS FOUND THE GRAFT WAS STUCK INSIDE THE SHEATH AND BROKEN. THE PULL-THROUGH TECHNIQUE WAS ADOPTED INSERTING A SNARE CATHETER FROM THE LEFT BRACHIAL ARTERY TO HOLD THE LUNDERQUIST WIRE GUIDE A NEW CONTRALATERAL ILIAC LEG DELIVERY SYSTEM WAS INSERTED BUT THIS ONE COULD NOT BE RELEASED EITHER. USING A CONVERTER WAS CONSIDERED BUT BECAUSE DEPLOYMENT OF AN ILIAC PLUG WAS CONSIDERED TO BE DIFFICULT, THE PROCEDURE WAS COMPLETED WITH NO ILIAC LEG GRAFT DEPLOYED IN EITHER ILIAC ARTERY. THE PT'S CONDITION REMAINED UNCHANGED COMPARED TO THE PRE-PROCEDURE CONDITION. AS OF TWO DAYS LATER, THE PHYSICIAN IS CONSIDERING USING A CONVERTER AND USING COILS TO EMBOLIZE THE CONTRALATERAL COMMON ILIAC, BUT HAS NOT YET DONE SO. THE PHYSICIAN COMMENTED ACCESS VESSEL DIAMETER WAS LARGE ENOUGH AND THERE WAS NO CALCIFICATION. HE STATED THE EVENT MAY HAVE OCCURRED DUE TO THE VESSEL BECOMING LESS FLEXIBLE, DUE TO AN OPEN SURGERY PERFORMED IN THE PAST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH AAA ENDOVASCULAR GRAFT ILLIAC LEG MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK, INC. NA F2167895

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention