BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG

    MDR report key: 3124040 · Received May 17, 2013

    Report

    Report Number
    1820334-2013-00205
    Event Type
    Injury
    Date Received
    May 17, 2013
    Date of Event
    April 22, 2013
    Report Date
    April 22, 2013
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OCCLUSION IS LABELED IN THE IFU. EVENT EVALUATION: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    A (B)(6) MALE ORIGINALLY UNDERWENT EVAR IN (B)(6) 2010 AS PART OF THE (B)(4) STUDY. A LOW PROFILE MAIN BODY AND TWO LOW PROFILE LIMBS WERE PLACED. ON (B)(6) 2011 THE PATIENT UNDERWENT A SECOND PROCEDURE DUE TO THE LEFT LIMB BEING 50% OCCLUDED. THE PHYSICIAN PLACED A SPIRAL Z ILIAC LEG GRAFT IN THE AORTA AND LIA FOR FULL COVERAGE OF STENOTIC AND THROMBOSED AREA WITH TOTAL COVERAGE OF THE PREVIOUSLY PLACED ENDOGRAFT. THERE WAS COMPLETE RESOLUTION OF THE STENOSIS AND NO EVIDENCE OF ANY FILLING DEFECT. ON (B)(6) 2012 THE PATIENT UNDERWENT A THIRD PROCEDURE DUE TO THE OTHER SIDE OCCLUDING AND THE PHYSICIAN PLACED A SPIRAL Z ILIAC LEG GRAFT ON THE RIGHT. THE PATIENT RETURNED FOR HIS 6-MONTH FOLLOW-UP VISIT FOLLOWING THE RESTENTING AND HAD A CTA ON (B)(6) 2013. ANOTHER PHYSICIAN REVIEWED THE CT AND THE PATIENT "HAS THROMBUS IN BOTH LIMBS AGAIN, WITH HIGH POTENTIAL TO EMBOLIZE" (1820334-2013-00205 AND 1820334-2013-00206). HE EXPLAINED THE SITUATION TO THE PATIENT, WHO IS VERY UPSET WITH THE NEWS, VERY UNHAPPY WITH THE STENTS, AND IS REFUSING TO HAVE ANY FURTHER INTERVENTION AT THIS TIME. THE PHYSICIAN IS VERY CONCERNED THAT THE PATIENT IS AT "HIGH RISK FOR EMBOLIZATION AND POTENTIAL LIMB LOSS." THIS PATIENT HAS BEEN PLACED ON PLAVIX AND IS SCHEDULED TO HAVE ANOTHER OFFICE VISIT AND CTA IN 3 MONTHS. ADDITIONAL INFORMATION RECEIVED (B)(6) 2013. THE PHYSICIAN DID HAVE PERFUSION AND OPEN LIMBS ON THE FINAL RUNS AFTER EACH ILIAC LEG WAS ADDED TO THE LP AND HE SAID THAT ON (B)(6) 2012 CASE WENT WELL AND THE ILIAC WAS OPEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218854 ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK, INC. NA 2793520

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention