BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2900555 · Received January 7, 2013

    Report

    Report Number
    2953200-2013-00037
    Event Type
    Injury
    Date Received
    January 7, 2013
    Date of Event
    December 10, 2012
    Report Date
    December 10, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS AND CONCLUSION: (INACCURATE STENT GRAFT DEPLOYMENT, VESSEL OCCLUSION). (INACCURATE STENT GRAFT DEPLOYMENT).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 6.2 CM DIAMETER ABDOMINAL AORTIC ANEURYSM APPROXIMATELY ONE MONTH AGO. IT WAS REPORTED THAT DURING DEPLOYMENT OF THE ENDURANT BIFURCATED STENT GRAFT ETBF2816C145E, THE PHYSICIAN'S RIGHT-HAND GLOVE BECAME ENTANGLED IN THE EXTERNAL SLIDER AND THE SCREW GEAR. DURING ATTEMPTS TO REMOVE THE GLOVE FROM THE SCREW GEAR MECHANISM, THE PARTIALLY DEPLOYED STENT GRAFT WAS ACCIDENTLY PULLED DOWN APPROXIMATELY 10-15MM FROM THE INTENDED LANDING ZONE. AN ENDURANT AORTIC CUFF WAS IMPLANTED AND UNINTENTIONALLY OCCLUDED THE LEFT RENAL ARTERY. THE DECISION WAS MADE TO PERFORM A SNORKEL IN ORDER TO RESTORE BLOOD FLOW TO THE LEFT RENAL ARTERY. THE ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7442 ENDURANT II ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V03009318

    Patients

    Seq Age Sex Outcome Treatment
    1 00093 YR Required Intervention