BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 3231843 · Received July 12, 2013

    Report

    Report Number
    1820334-2013-00292
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 6, 2013
    Report Date
    July 1, 2013
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVENT EVAL: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    INFORMATION FROM A STUDY INDICATES THAT A (B)(6) MALE PT UNDERWENT EVAR ON (B)(6) 2013. THE PHYSICIAN PLACED ZENITH ENDOGRAFTS INCLUDING ILIAC LIMBS WITH SPIRAL-Z TECHNOLOGY. THE PT HAD MODERATE LEFT ILIAC DISEASE AND CALCIFICATION WITH MILD LEFT ILIAC TORTUOSITY. THE RIGHT HAD MODERATE ILIAC OCCLUSIVE DISEASE AND CALCIFICATION WITH NO RIGHT ILIAC TORTUOSITY. AT THE END OF THE PROCEDURE IT WAS NOTED THAT THERE WAS A PROXIMAL TYPE I ENDOLEAK THAT HAD NOT BEEN RESOLVED BY THE END OF THE PROCEDURE. AS OF (B)(6) 2013, IT WAS NOTED THAT BOTH THE LEFT AND RIGHT ILIACS HAD EXTERNAL COMPRESSION. HOWEVER, AT THIS TIME IT IS UNK IF ANY ADDITIONAL DEVICES WERE PLACED AS IT WAS NOT PROVIDED BY THE REPORTER. ADDITIONAL QUESTIONS HAVE BEEN ASKED BUT INFORMATION HAS NOT YET BEEN PROVIDED. ADDITIONAL INFORMATION RECEIVED (B)(6) 2013 FROM THE STUDY INDICATED THAT THERE WAS A RIGHT AND LEFT ANGIOPLASTY PERFORMED IN THE LEG/LEG EXTENSION AFTER THE PROCEDURE DUE TO EXTERNAL COMPRESSION ON BOTH SIDES (1820334-2013-00292). THERE WAS NO EXTERNAL COMPRESSION OBSERVED AT THE CONCLUSION OF THE PROCEDURE. THE TYPE I ENDOLEAK WAS A PROXIMAL ENDOLEAK (1820334-2013-00293). ALL ZENITH DEVICES REMAIN IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323688 ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK, INC. NA 3993820

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention