BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH AAA ENDOVASCULAR GRAFT AAA ANCILLARY COMPONENT CONVERTER

    MDR report key: 1378145 · Received May 8, 2009

    Report

    Report Number
    1820334-2009-00274
    Event Type
    Injury
    Date Received
    May 8, 2009
    Date of Event
    February 24, 2009
    Report Date
    April 10, 2009
    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

    THE DEVELOPMENT OF THE ZENITH DEVICE SUCCESSFULLY COMPLETED ALL VERIFICATION AND VALIDATION ACTIVITIES SHOWING THE DEVICE MEETS THE DESIGN REQUIREMENTS AND THAT THE DESIGN REQUIREMENTS MEET THE NEEDS OF THE USER. EACH DEVICE IS SHIPPED WITH INSTRUCTIONS FOR USE (IFU) LISTING THE INDICATIONS FOR USE, CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, AND THE CORRECT DEPLOYMENT PROCEDURE. REGARDING ENDOLEAKS, THE IFU LISTS IMPORTANT FACTORS/WARNINGS THAT, IF FOLLOWED, COULD REDUCE THE LIKELIHOOD OF AN ENDOLEAK OCCURRING; ANATOMICAL CRITERIA. VESSEL TORTUOSITY. CALCIFICATION. ACCURATE PLACEMENT OF GRAFT. PROPER BALLOONING SITES WITHIN THE STENT GRAFT. THE EVENT EVALUATION FORM FROM COOK INCLUDED THE PHYSICIAN'S COMMENTS. THE PHYSICIAN WANTED TO KNOW ALL THE POSSIBLE AFFECTS FROM THE CONVERTER BEING BENT. WITH NO FILMS TO REVIEW AND NOT KNOWING THE EXTENT OF THE DAMAGE, IF ANY, THE AFFECTS CANNOT BE DETERMINED AT THIS TIME. HOWEVER, WE HAVE NOTIFIED THE APPROPRIATE INDIVIDUALS AND WE WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    A MALE PATIENT UNDERWENT AAA REPAIR IN 2009. THE PATIENT'S ANATOMICAL FORM WAS NOT SUITABLE FOR ENDOVASCULAR REPAIR SINCE OCCLUSION DUE TO THROMBUS WAS CONFIRMED AT THE RIGHT COMMON ILIAC ARTERY BEFORE THE PROCEDURE. BECAUSE OF THE PATIENT ANATOMY, IT WAS PLANNED TO PERFORM FEMORAL-TO-FEMORAL BYPASS SURGERY WITH THE CONVERTER. THE CONVERTER WAS PLACED AFTER PLACING THE MAIN BODY, AND BALLOONING WAS PERFORMED TO STABILIZE THOSE GRAFTS, THEN THE IPSILATERAL LEG WAS PLACED. CONFIRMATORY ANGIOGRAPHY REVEALED A TYPE I ENDOLEAK FROM PROXIMAL SITE. BALLOONING WAS PERFORMED TO RESOLVE THE ENDOLEAK AGAIN, BUT IT STILL REMAINED. A PTA CATHETER WAS USED TO STABILIZE THE CONVERTER. IT WAS CONFIRMED THAT THE ENDOLEAK WAS RESOLVED. TWO MONTHS LATER, CONFIRMATORY ANGIOGRAPHY WAS PERFORMED. THERE WAS NO ENDOLEAK, HOWEVER, A PART OF THE CONVERTER PROXIMAL SITE BENT INSIDE THE GRAFT. THE OUTCOME OF THE PATIENT AT THIS TIME IS UNK.

    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 F1970662

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention