BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II

    MDR report key: 3050562 · Received April 10, 2013

    Report

    Report Number
    2953200-2013-00655
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    March 15, 2013
    Report Date
    March 15, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS AND CONCLUSION: (RUPTURE/ENDOLEAK). DEVICE (CALCIFIED VESSELS). (BALLOON).

    Description of Event or Problem · 1

    AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. THE ANEURYSM DIAMETER WAS APPROXIMATELY 4-5CM. IT WAS REPORTED THAT INTRA-OPERATIVELY, AFTER MODELING THE BIFURCATED STENT GRAFT WITH A RELIANT BALLOON, THERE WAS A SUDDEN DROP IN THE PATIENT'S BLOOD PRESSURE. CHEST COMPRESSIONS WERE INITIATED, AND THE PHYSICIAN SUCCESSFULLY STABILIZED THE PATIENT'S BLOOD PRESSURE. THE PATIENT WAS INTUBATED AND TRANSFERRED TO THE ER. NO RUPTURE OR ENDOLEAK WAS INITIALLY SEEN ON THE POST-OP CT IMAGES. THE PATIENT UNDERWENT EXPLORATORY SURGERY, AND MASSIVE BLEEDING WAS DISCOVERED IN THE AREA OF THE AORTIC BIFURCATION. THE BIFURCATED STENT GRAFT WAS FOUND TO HAVE TORN IN THE AREA OF THE FLOW DIVIDER. THE TEAR WAS CLOSED WITH SUTURES, RESOLVING THE LEAK AND THE BLEEDING. REVIEW OF THE CT IMAGING SHOWED CALCIFICATION IN THE COMMON ILIAC ARTERIES AND DISTAL AORTA, WHICH THE PHYSICIAN BELIEVES CUT THE STENT GRAFT DURING THE BALLOONING PROCEDURE. THE PHYSICIAN DID NOT BALLOON MORE AGGRESSIVELY THAN USUAL. THE PATIENT'S TOTAL BLOOD LOSS WAS APPROXIMATELY 8-9 LITERS. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL 10 DAYS AFTER THE PROCEDURE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152757 ENDURANT II SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V02418056

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention