BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT ILIAC LEG

    MDR report key: 1833045 · Received September 8, 2010

    Report

    Report Number
    1820334-2010-00440
    Event Type
    Injury
    Date Received
    September 8, 2010
    Date of Event
    August 10, 2010
    Report Date
    August 12, 2010
    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

    PT AND DEVICE CODE: OCCLUSION IS ADDRESSED IN THE PROVIDED IFU. NO PRODUCT OR IMAGES WERE PROVIDED TO ASSIST IN THIS INVESTIGATION. THE ZENITH DEVICE HAS COMPLETED REQUIREMENTS SHOWING THE DEVICE MEETS THE PREDETERMINED REQUIREMENTS AND THAT THE REQUIREMENTS MEET THE NEEDS OF THE USER. EACH ZENITH DEVICE IS SHIPPED WITH INSTRUCTIONS FOR USE (IFU) LISTING THE INDICATIONS FOR USE, CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, AND THE CORRECT DEPLOYMENT PROCEDURE. IN REGARDS TO OCCLUSIONS, THE IFU LISTS SEVERAL WARNINGS/PRECAUTIONS THAT, IF FOLLOWED, COULD PREVENT THIS FAILURE MODE FROM OCCURRING OR LESSEN THE ASSOCIATED EFFECTS: ANATOMICAL CRITERIA, ANATOMICAL CONDITIONS, IMPORTANCE OF ACCURATE PLACEMENT. SPECIFIC TO THIS CASE THE IFU STATES, "VESSELS THAT ARE SIGNIFICANTLY CALCIFIED, OCCLUSIVE, TORTUOUS OR THROMBUS-LINED MAY PRECLUDE PLACEMENT OF THE ENDOVASCULAR GRAFT AND/OR MAY INCREASE THE RISK OF EMBOLIZATION." NO PRODUCT WAS RETURNED FOR INVESTIGATION; HOWEVER, NO EVIDENCE EXISTS TO CONTRADICT THE SUBSTANCE OF THIS REPORT. THE FAILURE MODE ASSIGNED TO THIS CASE IS OCCLUDED. THIS FAILURE MODE WAS DETERMINED BASED ON THE PROVIDED EVENT DESCRIPTION. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED OR REPORTED AT THIS TIME. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    A (B)(6) MALE PT UNDERWENT AAA REPAIR ON (B)(6)2010. THE PT'S ANATOMICAL FORM WAS SUITABLE FOR AAA REPAIR ALTHOUGH THE LENGTH OF BOTH COMMON ILIAC ARTERIES WERE ABOUT 10MM. THE PROCEDURE WAS CONDUCTED AS PRESCRIBED. THE DISTAL SEALING PART OF THE LEFT ILIAC LEG WAS UNSTUCK FROM COMMON ILIAC ARTERY AND THE DISTAL PART MIGRATED INTO THE ANEURYSM WHEN BALLOONING WAS PERFORMED AFTER ONE MAIN BODY AND TWO ILIAC LEGS WERE PLACED. THE ADD'L ILIAC LEG WAS PLACED AND SECURED WITH A BALLOON (1820334-2010-00402). ANGIOGRAPHY REVEALED BOTH SIDE OF INTERNAL ILIAC ARTERIES WERE OCCLUDED (1820334-2010-00403). THE PHYSICIAN DECIDED TO TAKE F/U OBSERVATION. ON (B)(6)2010, IT WAS OBSERVED THAT THE RIGHT ILIAC LEG WAS OCCLUDED. FEMORAL-TO-FEMORAL BYPASS SURGERY WAS PERFORMED. THE PROCEDURE WAS COMPLETED WITHOUT PROBLEM. THE CURRENT STATUS OF THE PT'S CONDITION IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH FLEX AAA ENDOVASCULAR GRAFT ILIAC LEG MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK, INC. NA 2520532

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Required Intervention