BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT ILIAC LEG

    MDR report key: 1871271 · Received October 15, 2010

    Report

    Report Number
    1820334-2010-00506
    Event Type
    Injury
    Date Received
    October 15, 2010
    Date of Event
    September 10, 2010
    Report Date
    September 13, 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

    OCCLUSION. EVENT EVAL: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    AN (B)(6) MALE PATIENT WHO SUFFERED FROM PULMONARY DISEASE UNDERWENT AAA REPAIR ON (B)(6) 2010. THE PT'S ANATOMICAL FORM WAS SUITABLE FOR AAA REPAIR. VASCULAR WALL AROUND ANEURYSM WAS WEAK AND DIAMETER FOR ANEURYSM WAS 75MM. FINAL ANGIOGRAPHY REVEALED LEFT INTERNAL ARTERY WAS OCCLUDED. THE PHYSICIAN ATTEMPTED TO PUSH THE LEFT ILIAC LEG UP WITH A BALLOON CATHETER, HOWEVER, IT WAS INVALID. ANOTHER MFR'S STENT WAS PLACED AT LEFT EXTERNAL ILIAC LEG FOR LONG TERM PROGNOSIS. 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 F2533557

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention