BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2993557 · Received March 7, 2013

    Report

    Report Number
    2953200-2013-00425
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    February 13, 2013
    Report Date
    February 13, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION METHOD: (FILM). EVALUATION RESULTS AND CONCLUSION: (ENDOLEAK). (CALCIFIED ILIAC ARTERIES).

    Description of Event or Problem · 1

    AN ENDURANT 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 19.7 MM IN DIAMETER AND 17 MM IN LENGTH AND HAS ATHEROSCLEROSIS. THE COMMON ILIAC ARTERIES WERE HEAVILY CALCIFIED. IT WAS REPORTED THAT THE BIFURCATED STENT GRAFT WAS INSERTED AND DEPLOYED BELOW THE RENAL ARTERY TO THE CONTRALATERAL GATE FOLLOWED BY DEPLOYMENT OF THE SUPRARENAL STENT. THE CONTRALATERAL SIDE WAS CANNULATED FOR ANGIOGRAPHY USING SHEATH. THE CONTRALATERAL LIMB WAS INSERTED FROM LEFT SIDE AND DEPLOYED WITH 3 STENT LENGTHS OF OVERLAP. THE DEVICE MOVED 0.5 - 1 STENT LENGTH DOWN FROM THE INTENDED LOCATION. THE PHYSICIAN PUSHED THE STENT GRAFT UPWARDS AND SECURED 2.5 STENT LENGTH OF OVERLAP THEN COMPLETED THE STENT GRAFT DEPLOYMENT. THE BIFURCATED STENT GRAFT WAS DEPLOYED COMPLETELY AND THE DELIVERY SYSTEM WAS REMOVED. TOUCH UP WITH ANOTHER MANUFACTURER'S BALLOON WAS PERFORMED; HOWEVER, A JUNCTION TYPE III ENDOLEAK WAS OBSERVED, THEREFORE, ANOTHER LONG INFLATION WAS DONE AT THE JUNCTION BUT THE ENDOLEAK DID NOT RESOLVE AS SEEN BY DSA. AN ENDURANT ILIAC 161093 WAS IMPLANTED IN THE AREA OF THE TYPE III ENDOLEAK AND BALLOONING WAS PERFORMED AT THE JUNCTION AGAIN BUT ENDOLEAK DID NOT RESOLVE. NO FURTHER INTERVENTION WAS PERFORMED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE. REVIEW OF RETURNED ANGIO IMAGES AT IMPLANT SHOW THAT THE BIFURCATE IPSILATERAL LIMB WAS PLACED JUST BELOW THE RENALS; EXTENDING INTO THE RIGHT ILIAC. THE CONTRALATERAL LIMB WAS PLACED IN THE GATE SLIGHTLY BELOW THE GATE MARKERS; APPROXIMATELY 2.5CM STENT GRAFT OVERLAP AT THE GATE. THERE IS A LIKELY TYPE III JUNCTIONAL ENDOLEAK SEEN IN THE LEFT DISTAL AAA, EMANATING FROM JUST BELOW THE GATE. THERE IS ALSO A LIKELY SEPARATE ENDOLEAK SEEN FROM THE BIFURCATE WHICH APPEARS AS A TYPE IV BLUSH FILLING THE MAJORITY OF THE AAA SAC. AFTER IMPLANTING THE LIMB ACROSS THE GATE, THE JUNCTIONAL ENDOLEAK APPEARS TO HAVE COMPLETELY RESOLVED; HOWEVER, THE LIKELY TYPE IV ENDOLEAK FROM THE BIFURCATE REMAINS. THE CAUSE OF THE TYPE III JUNCTION IS UNCERTAIN, AND IT IS UNKNOWN IF THE SLIGHTLY LESS THAN RECOMMENDED GATE OVERLAP MAY HAVE CONTRIBUTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96864 ENDURANT ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V00950387

    Patients

    Seq Age Sex Outcome Treatment
    1