BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT ILIAC LEG

    MDR report key: 1903531 · Received November 19, 2010

    Report

    Report Number
    1820334-2010-00574
    Event Type
    Injury
    Date Received
    November 19, 2010
    Date of Event
    October 15, 2010
    Report Date
    October 18, 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

    (B)(4). ADDITIONAL INFORMATION: NO PRODUCT OR IMAGES WERE RETURNED TO ASSIST WITH THIS INVESTIGATION. THIS PRODUCT LINE HAS ADDRESSED ALL DESIGN CONTROL REQUIREMENTS AND SHOWN THE DEVICE HAS MET THE PREDETERMINED REQUIREMENTS AND THAT THOSE REQUIREMENTS MEET THE NEEDS OF THE USER. EACH DEVICE IS SENT WITH INSTRUCTIONS FOR USE (IFU), WHICH DESCRIBES THE INDICATIONS FOR USE, WARNINGS, PRECAUTIONS, AND THE PROPER DEPLOYMENT SEQUENCE. SPECIFIC TO THIS CASE, THE IFU PROVIDES WARNINGS AND PRECAUTIONS INCLUDING: "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." THE FAILURE MODE ASSIGNED TO THIS CASE IS KINKED. THIS FAILURE MODE WAS DETERMINED BASED ON THE PROVIDED EVENT DESCRIPTION. IMAGES OF THE ANATOMY WERE NOT RETURNED TO ASSIST WITH THIS INVESTIGATION. A DEFINITIVE ROOT CAUSE CAN NOT BE REPORTED OR DETERMINED AT THIS TIME. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. NO ADDITIONAL ACTIONS REQUIRED AT THIS TIME. THE RISK IS INSUFFICIENT AND REMAINS AT AN ACCEPTABLE LEVEL AS A RESULT OF THIS COMPLAINT. NO FURTHER ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT UNDERWENT AAA REPAIR ON (B)(6) 2010. THE PATIENT'S ANATOMICAL FORM WAS NOT SUITABLE FOR AAA REPAIR SINCE BOTH SIDES OF COMMON ILIAC ARTERIES HAD ANEURYSM. (LEFT COMMON ILIAC ARTERY WAS PARTLY NORMAL BLOOD VESSEL.) THE RIGHT ILIAC LEG WAS PLACED INTO RIGHT EXTERNAL ARTERY AFTER COIL EMBOLIZATION OF RIGHT INTERNAL ILIAC ARTERY. IT WAS NOTED THAT THE STENT PLACED AT RIGHT EXTERNAL ARTERY WAS KINKED. ANOTHER MANUFACTURER'S STENT WAS PLACED AT RIGHT EXTERNAL ILIAC ARTERY FOR LONG TERM PROGNOSIS. 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. THEN THE PHYSICIAN DECIDED TO TAKE FOLLOW UP OBSERVATION. (1820334-2010-00564). THE CURRENT STATUS OF THE PATIENT'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 F2535423

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention