BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT STENT GRAFT

    MDR report key: 2153208 · Received June 23, 2011

    Report

    Report Number
    2953200-2011-01191
    Event Type
    Injury
    Date Received
    June 23, 2011
    Date of Event
    May 26, 2011
    Report Date
    May 26, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS: ENDOLEAK, NECK AND ILIAC TORTUOSITY, NECK > 60 DEGREES. EVALUATION CONCLUSION: NECK AND ILIAC TORTUOSITY, NECK > 60 DEGREES.

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. THE ANEURYSM SIZE IS UNKNOWN. THE AORTIC NECK WAS ANGLED ABOUT 60-70 DEGREES. THE DISTAL ANATOMY WAS DESCRIBED AS BEING VERY LONG AND VERY TORTUOUS BUT NOT CALCIFIED. THE ENDURANT BIFURCATED STENT GRAFT (MFR REPORT# 2953200-2011-01190) WAS DEPLOYED. THE FELLOW, WHO WAS NOT EXPERIENCED, WAS INSTRUCTED BY THE IMPLANTING PHYSICIAN TO ROTATE THE DEVICE WHILE PULLING DOWN. THE FELLOW SEEMED TO BE ROTATING THE DEVICE BUT WAS NOT PULLING DOWN, AND THE SPINDLE BECAME CAUGHT ON THE SUPRARENAL STENT. ONE ANCHORING PIN CAME DOWN, WHICH CAUSED THE STENT GRAFT TO AN INFOLD POSITION WHICH LED TO A PROXIMAL TYPE I ENDOLEAK. THE STENT GRAFT WAS BALLOONED MULTIPLE TIMES WITHOUT RESOLUTION OF THE TYPE I ENDOLEAK. A PROXIMAL CUFF WAS PLACED AND BALLOONED MULTIPLE TIMES BUT WAS UNSUCCESSFUL THE PATIENT HAD A TYPE I ENDOLEAK AT THE END OF THE PROCEDURE AND WILL BE MONITORED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT STENT GRAFT MIH MEDTRONIC CARDIOVASCULAR IRELAND NA V00854879

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention