BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH AAA ENDOVASCULAR GRAFT ILIAC LEG

    MDR report key: 1780750 · Received July 26, 2010

    Report

    Report Number
    1820334-2010-00370
    Event Type
    Injury
    Date Received
    July 26, 2010
    Date of Event
    June 30, 2010
    Report Date
    July 13, 2010
    Manufacturer
    COOK INC
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) OCCLUSION IS ADDRESSED IN THE IFU. 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 & 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 AND THE PHYSICIAN'S COMMENTS: "IT MAY BE OCCURRED DUE TO THAT PATIENT'S ANATOMICAL FORM." A DEFINITIVE ROOT CAUSE CAN NOT 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 PATIENT UNDERWENT AAA REPAIR ON (B)(6) 2010. THE PATIENT WAS NOT SUITABLE FOR ENDOVASCULAR REPAIR BECAUSE THE PROXIMAL NECK LENGTH WAS SHORT(12MM) AND THE ACCESS ROUTE WAS NARROW(4-6MM). THE PROCEDURE WAS CONDUCTED AS LABELED. ON (B)(6) 2010, THE PHYSICIAN RECOGNIZED THE CONTRALATERAL LEG WAS OCCLUDED DURING FOLLOW UP EXAMINATION. ON (B)(6) 2010 THE PHYSICIAN PLACED THE CONVERTER FROM THE IPSILATERAL AND THEN DID FEM-FEM BYPASS PROCEDURE. THERE WERE NO ADVERSE EFFECTS ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH AAA ENDOVASCULAR GRAFT ILIAC LEG MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK INC NA F2474284

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention