BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT BIFURCATED STENT GRAFT SYSTEM

    MDR report key: 2181395 · Received July 21, 2011

    Report

    Report Number
    2953200-2011-01306
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    June 16, 2011
    Report Date
    June 21, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: (OCCLUSION). RESULTS AND CONCLUSIONS: (NARROWING IN THE DISTAL AORTIC NECK).

    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 SEVEN WEEKS AGO. THE ANEURYSM AND VESSEL MORPHOLOGY WERE REPORTED AS A NARROWING IN THE DISTAL AORTIC NECK. THE GRAFT WAS IMPLANTED WITH A 180 DEGREE LIMB ORIENTATION, AS PLANNED. IT WAS REPORTED THAT THE PATIENT CAME IN WITH A LEFT LIMB OCCLUSION, APPROXIMATELY ONE MONTH AGO, WHICH REQUIRED LYTIC THERAPY AND SUBSEQUENT STENTING OF THE ENDOGRAFT LIMB (REF MFR. # 2953200-2011-01306). AFTER ANOTHER MANUFACTURER'S STENT WAS IMPLANTED IN THE LEFT LIMB, THE RIGHT LIMB SUBSEQUENTLY OCCLUDED (REF MFR. # 2953200-2011-01307), AS THE PHYSICIAN DID NOT PERFORM THE KISSING BALLOON TECHNIQUE. THE RIGHT LIMB OCCLUSION WAS RESOLVED WITH BALLOONING AND THE BLOOD FLOW WAS RESTORED. INTERNAL REVIEW OF A SINGLE STILL ANGIOGRAPHIC IMAGE AT IMPLANT, SHOWS THE LIMBS PATENT AND CROSSED, WITH POSSIBLE BUNCHING OF FABRIC AT THE IPSILATERAL LIMB, WHERE IT CROSSES (LIKELY NEAR THE AORTIC BIFURCATION). POST-IMPLANT FILMS SHOW THE LEFT LIMB OCCLUDED BEGINNING AT THE FLOW DIVIDER; THE RIGHT LIMB APPEARS PATENT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT BIFURCATED STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR IRELAND NA V00853375

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention