BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II

    MDR report key: 3103456 · Received May 9, 2013

    Report

    Report Number
    2953200-2013-00875
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 13, 2013
    Report Date
    April 15, 2013
    Manufacturer
    MRDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4), RESULTS: INHERENT RISK OF PROCEDURE (OCCLUSION), PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (ANATOMY RELATED; CALCIFIED AND TIGHT DISTAL AORTA), CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (ANATOMY RELATED; CALCIFIED AND TIGHT DISTAL AORTA).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 5.2 CM IN DIAMETER SACCULAR ABDOMINAL AORTIC ANEURYSM. THE VESSEL MORPHOLOGY WAS REPORTED THAT THE PROXIMAL AORTIC NECK WAS 21-21 MM DIAMETER. THE PROXIMAL AORTIC NECK LENGTH WAS 4.5 CM LONG. THE BIFURCATED STENT GRAFT AND AN EXTENSION WERE IMPLANTED ON THE RIGHT SIDE AND THE CONTRALATERAL LIMB WAS IMPLANTED ON THE LEFT SIDE, BOTH STENT GRAFTS WERE IMPLANTED WITHOUT COMPLICATION. THE ILIAC LIMBS WERE IMPLANTED CROSSING. THE PATIENT PRESENTED WITH WALKING ISSUES AND ADMITTED TO THE HOSPITAL, A HEPARIN DRIP WAS STARTED AND A CT SCAN WAS PERFORMED. THE CT REVEALED THAT THE BIFURCATED IPSILATERAL ILIAC LIMB WAS COMPLETELY CRUSHED AT THE TOP OF THE GATE. THE PHYSICIAN BELIEVES THAT THE CAUSE OF THE CRUSHING WAS DUE TO A CALCIFIED RING AT THE DISTAL AORTIC NECK THAT MEASURED 17 DOWN TO 15 MM IN DIAMETER AND THE COMPRESSION OF THE BIFURCATED STENT GRAFT DUE TO THE OVER-LAP OF THE STENT GRAFTS (BIFURCATED STENT GRAFT AND CONTRALATERAL ILIAC LIMB) COLUMN STRENGTH. THERE WAS CROSS FILLING FROM THE LEFT HYPOGASTRIC ARTERY TO THE RIGHT HYPOGASTRIC ARTERY, PROVIDING BLOOD FLOW TO THE RIGHT LEG. THE PHYSICIAN ELECTED TO TREAT THE PATIENT WITH AN ANGIOJET, THROMBOLYTICS AND IMPLANT TWO 10X37 BARE METAL STENTS IN THE BIFURCATED STENT GRAFT AND A 12 X 40 SELF-EXPANDING STENT IN THE DISTAL PART OF THE IPSILATERAL (RIGHT) LIMB BECAUSE THERE WAS SOME THROMBOSIS THAT WAS NOT REMOVED BY THE ANGIOJET OR THROMBOLYTICS MEDICATION. AFTER IMPLANTING THE BALLOON EXPANDABLE STENTS THE FLOW LUMEN WAS ACHIEVED ON 10 MM BILATERALLY IN THE PROXIMAL AREA OF THE ILIAC LIMBS. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE. REVIEW OF SEVERAL RETURNED STILL ANGIOGRAM AND CT IMAGES SHOWED CONFIRMED THE CALCIFIED AND SMALL DIAMETER DISTAL NECK. ANGIOGRAM IMAGES SHOWED THAT THE BIFURCATE AORTIC BODY APPEARED TO BE CRUSHED INWARD ON THE IPSILATERAL SIDE NEAR THE FLOW DIVIDER, AND THE IPSILATERAL LIMBS WERE PARTIALLY OCCLUDED. THE LIMBS WERE CROSSED. POST-INTERVENTION IMAGE SHOWED IMPROVED BLOOD FLOW IN THE IPSILATERAL LIMB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202825 ENDURANT II SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MRDTRONIC IRELAND V01703716

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR Required Intervention