BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH AAA ENDOVASCULAR GRAFT ILIAC LEG

    MDR report key: 1211130 · Received October 23, 2008

    Report

    Report Number
    1820334-2008-00618
    Event Type
    Injury
    Date Received
    October 23, 2008
    Date of Event
    September 25, 2008
    Report Date
    September 25, 2008
    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

    EACH ZENITH DEVICE IS SHIPPED WITH INSTRUCTIONS FOR USE (IFU) LISTING THE ANATOMICAL REQUIREMENTS, WARNINGS, PRECAUTIONS, AND THE CORRECT DEPLOYMENT PROCEDURE. AN INTERNAL CLINICAL REVIEW INDICATED THE EVENT WAS DUE TO USER ERROR BECAUSE THE PHYSICIAN CHOSE TO THE DEVICES EVEN THOUGH THE PATIENT WAS OUTSIDE OF COOK'S INDICATION FOR USE. HOWEVER, WE HAVE NOTIFIED THE APPROPRIATE INDIVIDUALS AND WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    A MALE WITH CEREBRAL INFARCTION AND A PREVIOUS HISTORY OF DOMICILIARY OXYGEN THERAPY WAS NOTED TO HAVE A PROXIMAL PART NOT ANATOMICALLY SUITABLE FOR ENDOVASCULAR REPAIR. THE ANGLE ABOVE THE RENAL ARTERY WAS 70 DEGREES. IN 2008, THE PATIENT UNDERWENT AAA REPAIR. AS THERE WAS A POSSIBILITY THAT THE SEALED SITE OF THE CONTRALATERAL ILIAC LEG SHIFTED TO THE ANEURYSM, THE PHYSICIAN THOUGHT THAT PERFORMING THE PROCEDURE AS LABELED WAS NOT ADEQUATE IN THIS CASE. THEREFORE, HE PLACED THE IPSILATERAL ILIAC LEG FIRST AND THEN PLACED THE CONTRALATERAL ILIAC LEG. FINAL ANGIOGRAPHY REVEALED A TYPE I ENDOLEAK IN THE PROXIMAL NECK (1820334-2008-00617) AND IN THE CONTRALATERAL DISTAL PART. AFTER BALLOONING THESE AREAS TO TREAT THE ENDOLEAKS, THE ENDOLEAK AT THE PROXIMAL NECK WAS ALMOST RESOLVED. THE ENDOLEAK AT THE CONTRALATERAL DISTAL PART WAS NOT RESOLVED, BUT THE PHYSICIAN DID NOT PERFORM AN ADDITIONAL PROCEDURE CONSIDERING THAT IT WOULD BE RESOLVED AFTER HEPARIN IN THE BLOOD WAS NEUTRALIZED. PATIENT OUTCOME IS UNKNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH AAA ENDOVASCULAR GRAFT ILIAC LEG MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK, INC. NA F2214624

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention