BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH AAA ENDOVASCULAR GRAFT AAA ANCILLARY COMPONENT CONVERTER

    MDR report key: 2008398 · Received February 18, 2011

    Report

    Report Number
    1820334-2011-00082
    Event Type
    Injury
    Date Received
    February 18, 2011
    Date of Event
    January 18, 2011
    Report Date
    January 19, 2011
    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). RUPTURES ARE LABELED IN THE IFU. THE DEVICE REMAINS IMPLANTED AND 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 STATES: "ACCESS VESSEL DIAMETER (MEASURED INNER WALL TO INNER WALL) AND MORPHOLOGY (MINIMAL TORTUOSITY, OCCLUSIVE DISEASE AND/OR CALCIFICATION) SHOULD BE COMPATIBLE WITH VASCULAR ACCESS TECHNIQUES AND DELIVERY SYSTEMS OF THE PROFILE OF A 14 FRENCH TO 20 FRENCH VASCULAR INTRODUCER SHEATH. 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 PT'S ANATOMY WAS OUTSIDE THE IFU BASED ON THE PROVIDED EVENT DESCRIPTION AND THE CONDITION OF THE ACCESS VESSELS. THE VESSEL MAY HAVE RUPTURED DURING INSERTION OR MANIPULATION OF THE MAIN BODY DELIVERY SYSTEM OR CONVERTER DELIVERY SYSTEM. PT ANATOMY LIKELY CONTRIBUTED TO THE REPORTED RUPTURE. THE RUPTURE WAS RESOLVED WITH PLACEMENT OF AN ADDITIONAL ILIAC LEG AND BALLOONING. WE WILL NOTIFY THE APPROPRIATE INTERNAL PERSONNEL OF THE EVENT AND CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. THE RISK ASSOCIATED WITH THIS FAILURE MODE WAS EVALUATED PER QUALITY ENGINEERING RISK ASSESSMENT (QERA) AND THE RISK ASSOCIATED WITH THE FAILURE MODE WILL REMAIN AT AN ACCEPTABLE LEVEL WITH INCLUSION OF THE EVENT. RISK MITIGATION IS NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    A (B)(6) MALE PT UNDER WENT AAA REPAIR ON (B)(6) 2011. THE PT'S ANATOMICAL FORM WAS NOT SUITABLE FOR THE PROCEDURE SINCE CHRONIC TOTAL OCCLUSION WAS OBSERVED, RIGHT COMMON ILIAC ARTERY WAS OCCLUDED AND LEFT EXTERNAL ILIAC ARTERY WAS STENOSED. PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY WAS PERFORMED FOR LEFT EXTERNAL ILIAC ARTERY, AND THE MAIN BODY WAS ABLE TO BE INSERTED WITH LEFT APPROACH. WHEN THE CONVERTER WAS INSERTED, STRONG RESISTANCE WAS ENCOUNTERED, BUT IT WAS PLACED. THEN THE ILIAC LEG WAS PLACED. ANGIOGRAPHY WAS PERFORMED AFTER BALLOONING. IT REVEALED EXTERNAL ILIAC ARTERY AROUND BIFURCATION AREA OF INTERNAL ILIAC ARTERY WAS RUPTURED. ADDITIONAL ILIAC LEG WAS PLACED OVER INTERNAL ILIAC ARTERY. IT CAUSED OCCLUSION OF INTERNAL ILIAC ARTERY. BALLOONING WAS PERFORMED AND THE RUPTURED EXTERNAL ILIAC ARTERY WAS FIXED. THE PT IS FINE AFTER THE PROCEDURE.

    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 F2580096

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention