BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 3024360 · Received March 27, 2013

    Report

    Report Number
    2953200-2013-00548
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 1, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION METHOD: (FILM). EVALUATION RESULTS: INHERENT RISK OF PROCEDURE (ENDOLEAK). UNAPPROVED USE OF DEVICE (STENT GRAFT WAS IMPLANTED IN A PATIENT WITH AN AORTIC NECK <(><<)> 19 MM IN DIAMETER). FAILURE TO FOLLOW INSTRUCTIONS (INSUFFICIENT STENT GRAFT OVERLAP AT THE GATE). EVALUATION CONCLUSION: OPERATIONAL CONTEXT CONTRIBUTED TO EVENT (STENT GRAFT WAS IMPLANTED IN A PATIENT WITH AN AORTIC NECK <(><<)> 19 MM IN DIAMETER). USER ERROR CONTRIBUTED TO EVENT (INSUFFICIENT STENT GRAFT OVERLAP AT THE GATE).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 52 MM DIAMETER ABDOMINAL AORTIC ANEURYSM APPROXIMATELY ONE MONTH AGO. THE PROXIMAL NECK WAS 17-18 MM IN DIAMETER AND 10 MM IN LENGTH WITH AN INFRARENAL ANGLE OF 41 DEGREES. THERE WAS MILD THROMBUS AND CALCIFICATION IN THE PROXIMAL AORTIC NECK. THE DIAMETER OF THE DISTAL AORTIC NECK WAS 20MM. THE RIGHT ILIAC ARTERY WAS 9.5MM IN DIAMETER AND THE LEFT WAS 10MM. THERE WAS MILD CALCIFICATION IN THE ILIAC ARTERIES. IT WAS REPORTED THAT THE BIFURCATED STENT GRAFT AND CONTRALATERAL LIMB WERE SUCCESSFULLY IMPLANTED. THE PHYSICIAN MODELED THE STENT GRAFT JUNCTION ARE WITH A BALLOON; HOWEVER, THERE WAS A TYPE III ENDOLEAK ON THE POST-BALLOON ANGIOGRAM. THE PHYSICIAN TREATED THIS WITH AN ENDURANT (B)(4) ILIAC STENT GRAFT WHICH WAS DEPLOYED WITHIN THE CONTRALATERAL GATE AND THE PROXIMAL END OF THE CONTRALATERAL LIMB. THE ENDOLEAK SUCCESSFULLY RESOLVED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE. REVIEW OF RETURNED FILMS AT IMPLANT SHOW THAT THE IPSILATERAL LIMB WAS PLACED ON THE RIGHT SIDE. HOWEVER, THE CONTRALATERAL LIMB WAS PLACED WITHIN THE GATE WITH THE OVERLAP MARKERS NOT SUFFICIENTLY ALIGNED. THERE WAS APPROXIMATELY 2 RING (2CM) OVERLAP, INSTEAD OF THE 3CM OVERLAP WHEN THE MARKERS ARE ALIGNED. POST-BALLOONING, A LIKELY TYPE III JUNCTIONAL ENDOLEAK IS SEEN AT THE GATE. THE ENDOLEAK IS RESOLVED AFTER A CUFF IS PLACED ACROSS THE GATE. THE CAUSE OF THE TYPE III ENDOLEAK IS UNCERTAIN, BUT IT IS POSSIBLE THAT THE LESS THAN RECOMMENDED GATE OVERLAP CONTRIBUTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126142 ENDURANT II ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V03049624

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Required Intervention