BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 3020052 · Received March 25, 2013

    Report

    Report Number
    2953200-2013-00532
    Event Type
    Injury
    Date Received
    March 25, 2013
    Date of Event
    February 27, 2013
    Report Date
    February 27, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: FILM. RESULTS: ENDOLEAK. LACK OF INFORMATION (UNKNOWN CAUSE AND LOCATION OF ENDOLEAK). CONCLUSIONS: LACK OF INFORMATION (UNKNOWN CAUSE AND LOCATION OF ENDOLEAK).

    Description of Event or Problem · 1

    AN ENDURANT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROXIMATELY THREE WEEKS AGO. THE AORTIC NECK WAS 20MM IN DIAMETER AT THE RENAL ARTERIES AND FOR 4CM BELOW THE RENAL ARTERIES THE AORTIC NECK WAS 22CM IN DIAMETER. IT WAS REPORTED THAT THE FINAL ANGIOGRAM REVEALED THAT THERE WAS AN UNKNOWN ENDOLEAK AS THERE WAS CONTRAST FILLING THE ANEURYSM SAC. THE PHYSICIAN PULLED THE CATHETER DOWN THROUGH THE STENT GRAFT WHILE INJECTING CONTRAST AS LITTLE AS 8CC SO AS NOT TO ALLOW CONTRAST IN ANY MEASURE TO THE PROXIMAL GRAFT OR THE SMA TO CONFIRM THERE WAS NO TYPE I OR TYPE II ENDOLEAK. MULTIPLE INJECTIONS WITH VARIOUS ANGLES FINALLY PROVIDED AN OPTIMAL VIEW OF CONTRAST READILY PENETRATING THE BODY OF THE BIFURCATED STENT GRAFT ON THE IPSILATERAL LIMB SIDE. THE PHYSICIAN DOES NOT BELIEVE THAT THE ENDOLEAK IS A POROSITY TYPE IV ENDOLEAK. THE PHYSICIAN DECIDED TO RELINE THE BIFURCATED STENT GRAFT WITH AN ENDURANT AORTIC CUFF 252549 AND THIS SHOWED MUCH IMPROVEMENT WITH A MUCH SMALLER ENDOLEAK PERSISTING AT OR NEAR THE IPSILATERAL LIMB. THE PHYSICIAN THEN RELINED THE IPSILATERAL LIMB WITH AN ENDURANT 161382 WHICH ALMOST ELIMINATED THE ENDOLEAK. THE PHYSICIAN BELIEVES THAT THE ENDOLEAK WILL RESOLVE WITHOUT FURTHER TREATMENT. THE PATIENT WILL BE MONITORED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED. REVIEW OF RETURNED ANGIO IMAGES AT IMPLANT SHOW A LARGE ENDOLEAK NEAR THE PATIENT LEFT SIDE OF THE BIFURCATE FLOW DIVIDER. THIS APPEARS TO BE A TYPE IV ENDOLEAK, BUT CANNOT RULE OUT A TYPE III FABRIC. FOLLOWING PLACEMENT OF AN AORTIC CUFF AND A LIMB, THE ENDOLEAK (ALTHOUGH REDUCED) IS STILL SEEN IN THE SAME LOCATION. THE CAUSE CANNOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122973 ENDURANT II ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V00940242

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Required Intervention