BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH AAA ENDOVASCULAR GRAFT AAA ANCILLARY COMPONENT CONVERTER

    MDR report key: 1903369 · Received November 12, 2010

    Report

    Report Number
    1820334-2010-00569
    Event Type
    Injury
    Date Received
    November 12, 2010
    Date of Event
    October 13, 2010
    Report Date
    October 14, 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 IN 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 EMPHASIZES THAT MORPHOLOGY SHOULD BE COMPATIBLE WITH VASCULAR ACCESS TECHNIQUES AND DELIVERY SYSTEMS OF A 14-22 FR INTRODUCER SHEATH. THE IFU PROVIDES RECOMMENDATIONS FOR PROPER SELECTION OF GRAFT SIZE BASED ON PATIENTS SPECIFIC VESSEL DIAMETER. THE FAILURE MODE ASSIGNED TO THIS CASE IS DISSECTION. THIS FAILURE MODE WAS DETERMINED BASED ON THE PROVIDED EVENT DESCRIPTION. A DEFINITIVE ROOT CAUSE CAN NOT BE DETERMINED OR REPORTED AT THIS TIME. HOWEVER, THE PATIENT'S ANATOMY MAY HAVE BEEN A CONTRIBUTING FACTOR TO THE DISSECTION. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. THE RISK ASSOCIATED WITH THE FAILURE MODE WILL REMAIN AT AN ACCEPTABLE LEVEL.

    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 THE PROCEDURE BECAUSE HIS ACCESS ROUTE WAS NARROW. THE RIGHT SIDE WAS CUT AND A MAINBODY AND A LEG GRAFT WAS DEPLOYED. THE PHYSICIAN ATTEMPTED TO INSERT A CONVERTER DELIVERY SYSTEM AND ADVANCE, BUT IT GOT STUCK AT THE NARROW PART IN THE EXTERNAL ILIAC ARTERY AND WOULD NOT ADVANCE ANY FURTHER. PTA WAS PERFORMED AND THE CUT WAS EXTENDED TO THE EXTERNAL ILIAC ARTERY TO ADVANCE THE DELIVERY SYSTEM, BUT THE EXTERNAL ILIAC ARTERY WAS RUPTURED SEVERELY, AND THE MAINBODY WAS PUSHED UP BY THE EDGE OF THE DELIVERY SYSTEM. THE PHYSICIAN DECIDED TO CONVERT TO THE OPEN SURGERY. THE PATIENT'S CONDITION AFTER THE PROCEDURE WAS UNKNOWN AS NOT PROVIDED BY REPORTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH AAA ENDOVASCULAR GRAFT AAA ANCILLARY COMPONENT CONVERTER MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK, INC. NA F2144184

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention