BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT ILIAC LEG

    MDR report key: 2032659 · Received March 16, 2011

    Report

    Report Number
    1820334-2011-00141
    Event Type
    Injury
    Date Received
    March 16, 2011
    Date of Event
    February 17, 2011
    Report Date
    February 18, 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

    PT OUTCOME WAS NOT PROVIDED BY THE REPORTER. ENDOLEAKS ARE LABELED IN THE IFU. NO PRODUCT OR IMAGES HAVE RETURNED TO ASSIST IN THE INVESTIGATION AT THIS TIME. THE ZENITH DEVICE HAS COMPLETED DESIGN CONTROL 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 AND PRECAUTIONS, AND THE CORRECT DEPLOYMENT PROCEDURE. IN REGARDS TO ENDOLEAKS, 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, PROPER BALLOONING SITES, F/U GUIDELINES, THE IMPORTANCE OF AN ACCURATE DEPLOYMENT. IMAGES WERE REQUESTED, BUT NOT YET PROVIDED. THE COMPLAINT FILE WILL BE UPDATED AS NEEDED AS ADD'L INFO IS RECEIVED. THE ACT AT TIME OF ANGIOGRAPHY WAS 362. EXCESSIVE ANTICOAGULATION DURING THE CASE LIKELY CONTRIBUTED TO THE REPORTED ENDOLEAK. IT IS REASONABLE TO SUGGEST THAT A TYPE 4 ENDOLEAK WILL RESOLVE SPONTANEOUSLY, ESPECIALLY AFTER HEPARIN NEUTRALIZATION, BASED ON PREVIOUS COMPLAINTS AND CLINICAL REVIEW. 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

    ON (B)(6) 2011, A (B)(6) YEAR OLD FEMALE PT, WITH AAA, CONGESTIVE HEART FAILURE, AND HYPERTENSION, UNDERWENT AAA REPAIR. THE PT'S ANATOMICAL FORM WAS SUITABLE FOR THE PROCEDURE AND THE PROCEDURE WAS CONDUCTED AS LABELED. BALLOONING USING A CODA BALLOON WAS PERFORMED AFTER A MAINBODY AND TWO ILIAC LEG GRAFTS. A DISTAL TYPE I ENDOLEAK IN THE LEFT WAS CONFIRMED, SO ADD'L BALLOONING USING MAXI LD BALLOON CATHETER WAS PERFORMED. AFTER DEFLATING THE BALLOON, BLOOD PRESSURE REDUCTION WAS CONFIRMED, SO URGENTLY OCCLUDED USING A CODA BALLOON. THEN THE LEFT COMMON ILIAC ARTERY RUPTURE WAS CONFIRMED ANGIOGRAPHICALLY. TO SOLVE THIS, THE PHYSICIAN COIL EMBOLIZED THE INTERNAL ILIAC ARTERY AND ADDITIONALLY PLACED TWO ILIAC LEG GRAFTS TO THE EXTERNAL ILIAC ARTERY. MFR REPORT # 1820334-2011-00140. ANOTHER LEAK WAS CONFIRMED FROM THE RIGHT SIDE AND DETERMINED AS TYPE III OR TYPE IV FROM THE ANGIOGRAPHY INSIDE THE STENT GRAFT. ACT WAS 362. THE LEAK WAS SOLVED BY ADD'L PLACEMENT OF A LEG GRAFT. PT OUTCOME WAS NOT PROVIDED BY THE REPORTER.

    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 F2563834

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention