BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2923094 · Received January 18, 2013

    Report

    Report Number
    2953200-2013-00133
    Event Type
    Injury
    Date Received
    January 18, 2013
    Date of Event
    November 14, 2012
    Report Date
    December 21, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: STENT GRAFT OCCLUSION, INACCURATE STENT GRAFT DELIVERY. PRE-OPERATIVELY RUPTURED ANEURYSM, SEVERELY CALCIFIED AORTA AND ILIAC ARTERIES. STENT GRAFTS WERE USED FOR TREATMENT OF A PATIENT WITH A PRE-OPERATIVELY RUPTURED ANEURYSM. CONCLUSION: PRE-OPERATIVELY RUPTURED ANEURYSM, SEVERELY CALCIFIED AORTA AND ILIAC ARTERIES. STENT GRAFTS WERE USED FOR TREATMENT OF A PATIENT WITH A PRE-OPERATIVELY RUPTURED ANEURYSM.

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ACUTE RUPTURE OF AN ABDOMINAL AORTIC ANEURYSM APPROXIMATELY TWO MONTHS AGO. THE PATIENT'S ACCESS VESSELS WERE SEVERELY CALCIFIED AS WELL AS THE AORTA DISTAL AND PROXIMAL TO THE ANEURYSM. AN ENDURANT BIFURCATED STENT GRAFT ETBF2813C124E, TWO AORTIC CUFFS ETCF2828C49E, AN ETEW1010C82E, AN ETLW1610C93E AND AN ETLW1613C93E WERE SUCCESSFULLY IMPLANTED. DURING THE ORIGINAL IMPLANT THE PHYSICIAN ACCIDENTALLY PULLED THE BIFURCATED STENT GRAFT INTO THE ANEURYSM SAC AND NEEDED TO PLACE TWO AORTIC CUFFS TO BUILD UP TO THE RENAL ARTERIES TO GET A SEAL. POST ANGIOGRAPHY SHOWED NO ENDOLEAK. NO COMPLICATIONS WERE REPORTED SINCE THE TIME OF IMPLANT. THE PATIENT RETUNED EMERGENTLY FIVE WEEKS POST IMPLANT WITH LEG PAIN. AN ANGIOGRAPHY SHOWED THE STENT GRAFT OCCLUDED BILATERALLY FROM THE RENAL ARTERIES DOWN TO BOTH HYPOGASTRIC ARTERIES. A CUT DOWN WAS DONE ON BOTH COMMON FEMORAL ARTERIES TO CONTROL THE THROMBUS DISTALLY. THERE WAS DIFFICULTY GETTING A WIRE UP THE LEFT SIDE PAST THE FLOW DIVIDER. A THROMBECTOMY WAS PERFORMED USING AN OVER THE WIRE FOGARTY CATHETER AND ANGIOJET. AFTER BALLOONING BOTH LIMBS, 10X37 BES WERE PLACED 1CM ABOVE THE FLOW DIVIDER EXTENDING INTO THE LIMBS FOLLOWED BY POST DILATATION WITH 14MM BALLOONS. THIS WAS FOLLOWED BY PLACEMENT OF 14X60 SES DISTAL TO THE PREVIOUS BES INTO THE LIMBS. THE ANGIOGRAM SHOWED CONTINUED THROMBUS IN THE BODY OF THE BIFURCATED STENT GRAFT AND LIMBS. TWO 16X13 LIMBS WERE PLACED UP TO JUST BELOW THE RENAL ARTERIES AND THEY WERE POST DILATED WITH KISSING 14MM BALLOONS. THE PHYSICIAN DILATED THROUGHOUT THE GRAFT AND HAD BLOOD FLOW THROUGH BOTH SIDES AND DISTALLY. THERE WAS STILL THROMBUS VISIBLE JUST ABOVE THE STENT GRAFTS, WHICH WAS BALLOONED WITH THE TWO 14MM BALLOONS. THERE WAS NOW NO VISIBLE THROMBUS IN THE AORTA OR THE STENT GRAFTS AND THERE WAS GOOD FLOW DISTALLY. HOWEVER, BOTH RENAL ARTERIES WERE EMBOLIZED. BOTH RENAL ARTERIES WERE ABLE TO BE ACCESSED AND THROMBUS WAS REMOVED WITH AN EXPORT CATHETER AND STENTS WERE PLACED IN EACH RENAL ARTERY OSTIUM. THE FOLLOW UP ANGIOGRAPHY SHOWED PATENT STENT GRAFT, RENAL ARTERIES AND VISCERAL VESSELS. THE PATIENT WAS DOING REMARKABLY WELL THE NEXT DAY WITH NO PAIN. THE PATIENT HAD A SLIGHT ELEVATION IN CREATININE THAT WAS BEING TREATED WITH HYDRATION. IT WAS ALSO REPORTED THAT DURING THE OCCLUSION REPAIR, THE PHYSICIAN NOTED A STENOSIS IN THE RIGHT COMMON ILIAC WITHIN THE STENT GRAFT, WHICH HAD BEEN NOTED AT THE TIME OF IMPLANT, BUT WAS NOT ADDRESSED. ALSO DURING THIS REPAIR THE LOWEST CUFF WAS PARTIALLY OVER THE FLOW DIVIDER AT THE LEFT LIMB WHICH WAS REPAIRED WITH 2 BES. THE LEFT LIMB BELOW THE LEVEL OF THE CONTRALATERAL GATE HAD A STENOSIS, AT THE LEVEL OF THE CALCIFICATION IN THE DISTAL AORTA. ALL THE STENOSIS WAS ADDRESSED WITH NON-COMPLIANT BALLOONS. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28079 ENDURANT II ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01705056

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Required Intervention