BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT

    MDR report key: 4233392 · Received November 6, 2014

    Report

    Report Number
    2953200-2014-02345
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    October 6, 2014
    Report Date
    December 4, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CT FILMS WERE RECEIVED AND THE EVALUATION HAS BEEN COMPLETED. REVIEW OF CT¿S FROM 7-DAYS POST-IMPLANT CONFIRMED THAT THE AORTIC CUFF WAS POSITIONED JUST BELOW THE LOWEST RIGHT RENAL ARTERY. THE BIFURCATE WAS 1CM BELOW THE CUFF. THE STENT GRAFT PROXIMAL OD IS 22MM. THE IPSI LIMB AND EXTENSION WERE PLACED DOWN INTO THE RIGHT EXTERNAL ILIAC ARTERY; THE RIGHT INTERNAL WAS COILED. THE CONTRA LIMB WAS POSITIONED DISTALLY WITH 3 STENTS EXTENDED INTO THE LEFT COMMON ILIAC ARTERY. THE MAX DIAMETER AAA IS 5.4CM. THERE IS CONTRAST SEEN WITHIN THE SAC, THIS APPEARS TO BE A TYPE II. THERE IS ALSO CONTRAST SEEN WITHIN THE DISTAL SAC; THE ENDOLEAK MAY BE CONTRAST RUNOFF FROM THE SAME TYPE II, OR A SEPARATE DISTAL TYPE I OR TYPE III FABRIC FROM THE CONTRA/LEFT LIMB. THE CONTRA/LEFT DISTAL STENT GRAFT OD IS 12MM AND THERE IS SEVERE VESSEL CALCIFICATION IN THIS LOCATION. REVIEW OF CTA¿S FROM 6-MONTHS POST-IMPLANT CONFIRMED THAT THE AORTIC CUFF WAS POSITIONED JUST BELOW THE LOWEST RIGHT RENAL ARTERY. THE BIFURCATE WAS 1CM BELOW THE CUFF. THE STENT GRAFT PROXIMAL OD IS 23MM. THE CONTRA LIMB WAS POSITIONED WITH 2 OR 3 STENTS EXTENDED INTO THE LEFT COMMON ILIAC ARTERY. THE MAX DIAMETER AAA IS 5.0CM. THERE IS CONTRAST SEEN WITHIN THE SAC FROM A TYPE II. THERE IS ALSO CONTRAST SEEN WITHIN THE DISTAL SAC; THE ENDOLEAK MAY BE CONTRAST RUNOFF FROM THE SAME TYPE II, OR A SEPARATE DISTAL TYPE I OR TYPE III FABRIC FROM THE CONTRA/LEFT LIMB. THE CONTRA/LEFT DISTAL STENT GRAFT OD IS 13MM. THE LIMBS ARE PATENT. REVIEW OF CTA¿S FROM 26-MONTHS POST-IMPLANT CONFIRMED THAT THE AORTIC CUFF WAS POSITIONED JUST BELOW THE LOWEST RIGHT RENAL ARTERY. THE BIFURCATE WAS 1CM BELOW THE CUFF. THE STENT GRAFT PROXIMAL OD IS 23MM. THE CONTRA LIMB WAS POSITIONED WITH 2 STENTS EXTENDED INTO THE LEFT COMMON ILIAC ARTERY. THE MAX DIAMETER AAA IS 6.5CM. THERE IS CONTRAST SEEN WITHIN THE SAC FROM A TYPE II. THERE IS ALSO CONTRAST SEEN WITHIN THE DISTAL SAC; THE ENDOLEAK MAY BE CONTRAST RUNOFF FROM THE SAME TYPE II, OR A SEPARATE DISTAL TYPE I OR TYPE III FABRIC FROM THE CONTRA/LEFT LIMB. THE CONTRA/LEFT DISTAL STENT GRAFT OD IS 14MM AND THERE IS VESSEL CALCIFICATION SEEN ALONG THE LENGTH OF THIS SHORT DISTAL SEAL. THE LIMBS ARE PATENT. THE CAUSE OF THE TYPE II ENDOLEAK IS ANATOMY RELATED. THE ENDOLEAK OBSERVED IN THE DISTAL SAC APPEARS TO BE COMING FROM THE DISTAL END OF THE CONTRA/LEFT LIMB. THE TYPE OF ENDOLEAK IS UNCERTAIN, BUT APPEARS MOST LIKELY TO BE A DISTAL TYPE I, BUT CANNOT RULE OUT A TYPE III FABRIC. THE STENT GRAFT SEAL LENGTH APPEARS TO HAVE SHORTED DURING THE IMPLANT DURATION, POSSIBLY DUE TO VESSEL MORPHOLOGY CHANGES. THE CALCIFIED LEFT ILIAC ARTERY MAY HAVE ALSO CONTRIBUTED TO THE ENDOLEAK.

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED INTO A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 5.6 CM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. VESSEL MORPHOLOGY AT THE TIME OF THE INDEX PROCEDURE WAS REPORTED AS THE AORTIC NECK WAS 18 MM IN DIAMETER AT THE RENAL ARTERIES. AT THE TIME OF IMPLANT THE PROCEDURE WAS COMPLETED AND THE TYPE IV ENDOLEAK WAS RESOLVED. ON THE 6 MONTHS FOLLOW UP A TYPE2 ENDOLEAK WAS OBSERVED. A RECENT FOLLOW UP REVEALED THAT THE ANEURYSM SEEMED TO BE ENLARGED. BUT SIGNIFICANT ENDOLEAK WAS NOT ABLE TO BE CONFIRMED AND THE PATIENT WAS DECIDED TO BE MONITORED BECAUSE INFECTION WAS SUSPECTED, (NOT STENT GRAFT RELATED). THE PATIENT PRESENTED TO THE HOSPITAL WITH LOWER BACK ACHE AND FEVER. THE PATIENT WAS HOSPITALIZED AFTER AN INFECTION (THE INFECTION WAS NOT RELATED TO STENT GRAFT) WAS DIAGNOSED, AND ANTIBIOTIC TREATMENT WAS GIVEN TO THE PATIENT. IT WAS REPORTED THAT THERE WAS A POSSIBLE TYPE IB ENDOLEAK OR TYPE III ENDOLEAK, FABRIC FROM A CERTAIN POINT OF CONTRA LIMB 16X13X124. ANOTHER MANUFACTURER¿S STENT GRAFT WAS IMPLANTED TO RELINE THE ILIAC LIMB EXTENDING THE COVERAGE AND THIS PROCEDURE WAS COMPLETED. THE TYPE IB OR III ENDOLEAK, FABRIC WAS RESOLVED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713956 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01112274

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Required Intervention