BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    MDR report key: 1993449 · Received February 8, 2011

    Report

    Report Number
    1820334-2011-00102
    Event Type
    Injury
    Date Received
    February 8, 2011
    Date of Event
    January 28, 2011
    Report Date
    January 31, 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 IFU. 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 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 16 FRENCH TO 22 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 IFU ALSO PROVIDES RECOMMENDATIONS FOR PROPER SELECTION OF GRAFT SIZE BASED ON PT'S 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 COULD NOT BE DETERMINED AT THIS TIME. THE PT'S ANATOMY WAS OUTSIDE THE IFU, AS THE ACCESS VESSEL WAS TOO SMALL. THIS CONDITION WAS LIKELY A CONTRIBUTING FACTOR TO THIS DISSECTION. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. THE RISK ASSOCIATED WITH THE FAILURE MODE WILL REMAIN AT AN ACCEPTABLE LEVEL, PER QUALITY ENGINEERING RISK ANALYSIS (QERA).

    Description of Event or Problem · 1

    ON (B)(6) 2011, AN (B)(6) MALE PT UNDERWENT AAA REPAIR. THE PT'S ANATOMICAL FORM WAS NOT SUITABLE FOR THE PROCEDURE BECAUSE THE NARROWEST PART OF THE CALCIFIED RIGHT EIA WAS 4.5 MM AND THE RIGHT CIA WAS PORCELAIN. THE LEFT EIA WAS CALCIFIED AND THE RIGHT BELOW THE ILIAC BIFURCATION WAS 2.5 MM. THE PHYSICIAN INSERTED THE MAINBODY DELIVERY SYSTEM OVER A LUNDERQUIST AFTER DILATATION OF THE LEFT AND THE RIGHT EIA USING A BALLOON CATHETER (BOSTON/WANDA), BUT THE SYSTEM WOULD NOT ADVANCE IN THE RIGHT EIA. SO THE PHYSICIAN WITHDREW THE SYSTEM AND THE BLOOD PRESSURE DECREASED TO FORTY SOMETHING. A DAMAGE TO THE RIGHT EIA WAS CONFIRMED BY PERFORMING ANGIOGRAPHY FROM THE RIGHT PERIPHERY, SO THE PHYSICIAN OCCLUDED THE DAMAGED PART USING A 8 MM BALLOON (BOSTON/WANDA) AND THE PT WAS SENT TO THE OPERATING ROOM TO REPAIR THE RUPTURED RIGHT EIA. THE PT WAS DOING FINE AFTER THE REPAIR PROCEDURE. AN IMPLEMENTATION OF OPERATIVE SURGICAL PROCEDURE TO TREAT AAA WILL BE CONSIDERED LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK, INC. NA F2563682

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention