BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANTABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2041582 · Received March 30, 2011

    Report

    Report Number
    2953200-2011-00719
    Event Type
    Injury
    Date Received
    March 30, 2011
    Date of Event
    February 28, 2011
    Report Date
    February 28, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: (VESSEL PERFORATION, ENDOLEAK), (SEVERELY CALCIFIED AORTIC NECK AND ILIAC ARTERIES). (SHORT NECK, SEVERLY CALCIFIED VESSELS, BALLOONING OF ANCHORING PINS, OVERSIZING OF DEVICE). EVALUATION, CONCLUSION: (SEVERELY CALCIFIED AORTIC NECK AND ILIAC ARTERIES). (BALLOONING OF ANCHORING PINS, OVERSIZING OF DEVICE).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT WAS IMPLANTED INTO A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM, APPROX ONE MONTH AGO. VESSEL MORPHOLOGY WAS REPORTED AS SEVERELY CALCIFIED AORTIC NECK AND ILIAC ARTERIES. THE NECK WAS 10 MM LONG AND 17 MM IN DIAMETER, PROXIMALLY AND 20 MM, DISTALLY. IT WAS REPORTED THAT THE DELIVERY SYSTEM WAS ATTEMPTED TO BE INSERTED FROM THE LEFT SIDE, HOWEVER, COULD ONLY BE ADVANCED 2 CM. THE DELIVERY SYSTEM WAS REMOVED FROM THE PT AND THE PHYSICIAN ATTEMPTED ACCESS FROM THE RIGHT SIDE. IT WAS DIFFICULT TO GET THE DELIVERY SYSTEM INSERTED BUT EVENTUALLY THE STENT GRAFT WAS DEPLOYED. THERE WAS A PROXIMAL TYPE I ENDOLEAK (REF. MFR. 2953200-2011-00720) AND THE PHYSICIAN ELECTED TO BALLOON THE ANCHORING PINS WITH A RELIANT BALLOON. THE ENDOLEAK DID NOT RESOLVE AND THERE WAS SOME EXTRAVASATION OF BLOOD; HOWEVER, THE BLOOD PRESSURE DID NOT DROP. THE PHYSICIAN THEN IMPLANTED A PROXIMAL AORTIC CUFF AND THE ENDOLEAK AND EXTRAVASATION RESOLVED. NO CLINICAL SEQUELAE WERE REPORTED, AND THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANTABDOMINAL STENT GRAFT SYSTEM MIH MEDTRONIC IRELAND NA V00832059

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Required Intervention