BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II STENT GRAFT SYSTEM

    MDR report key: 2770894 · Received October 3, 2012

    Report

    Report Number
    2953200-2012-01899
    Event Type
    Injury
    Date Received
    October 3, 2012
    Date of Event
    September 5, 2012
    Report Date
    September 5, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: INHERENT RISK OF PROCEDURE (REMOVAL DIFFICULTY, SURGICAL PROCEDURE). PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (ANATOMY RELATED; BILATERAL SEVERE CALCIFICATION, AND TORTUOSITY). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (ANATOMY RELATED; BILATERAL SEVERE CALCIFICATION, AND TORTUOSITY).

    Description of Event or Problem · 1

    AN ENDURANT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL ANEURYSM APPROXIMATELY ONE MONTH AGO. VESSEL MORPHOLOGY WAS REPORTED AS THE ILIAC ARTERIES WERE TORTUOUS AND SEVERELY CALCIFIED (CONTAINED PLAQUE) BILATERALLY. THE PROCEDURE WAS DONE PERCUTANEOUSLY WITH LOCAL ANESTHESIA. DURING THE PROCEDURE, THE PATIENT HAD SOME PAIN AND THE ANESTHESIOLOGIST SAID THAT IS COMMON IN THESE PROCEDURES. IT WAS REPORTED THAT THE STENT GRAFT WAS DEPLOYED AND THE CONTRALATERAL GATE WAS CANNULATED. THE NOSE CONE WAS THEN DOCKED INTO THE GRAFT COVER; HOWEVER, A LARGE CHUNK OF CALCIUM CAME IN BETWEEN THE GRAFT COVER (SHEATH) AND THE NOSE CONE. IT WAS NOT POSSIBLE TO COMPLETELY DOCK THE NOSE CONE AND TO REMOVE THE DELIVERY SYSTEM FROM THE PATIENT. ATTEMPTS TO DO SO CONTINUED FOR 1.5 HOURS. FINALLY, THE DECISION WAS MADE TO DO A RETROPERITONEAL CUT DOWN, REMOVE THE PLAQUE AND REMOVE THE DELIVERY SYSTEM FROM THE PATIENT. THE STENT GRAFT WAS ACCURATELY PLACED AND DID NOT MOVE DURING THIS PROCESS. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT II STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01099453

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention