BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2201745 · Received August 5, 2011

    Report

    Report Number
    2953200-2011-01401
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    July 18, 2011
    Report Date
    July 18, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: (GRAFT OCCLUSION).

    Description of Event or Problem · 1

    AN ENDURANT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A 5 CM ABDOMINAL AORTIC ANEURYSM. ILIAC VESSELS WERE 10-14 MM IN DIAMETER ON THE RIGHT AND 9-14 MM IN DIAMETER ON THE LEFT. IT WAS REPORTED THAT AFTER THE STENT GRAFTS WERE IMPLANTED, THERE WAS AN ATYPICAL TYPE OF ENDOLEAK AT THE LEVEL OF THE HIPS OF THE BIFURCATED STENT GRAFT HIP; IT WAS UNK WHETHER THIS WAS A TYPE II OR A TYPE III ENDOLEAK. THE PHYSICIAN TRIED REPEATED BALLOONING WITH BALLOONS FROM OTHER MANUFACTURERS; HOWEVER, THE ENDOLEAK WAS STILL PRESENT. CONTRAST WENT THROUGH THE STENT GRAFT COMPLETELY, AND THERE APPEARED TO BE A MINOR JET; IT WAS NOT CLEAR WHETHER THIS WAS ON THE IPSILATERAL SIDE OR THE CONTRALATERAL SIDE. NO FURTHER INTERVENTION WAS DONE, AND THE DECISION WAS MADE TO MONITOR THE PT. APPROXIMATELY 1.5 WEEKS POST-IMPLANTATION, THE PT PRESENTED WITH A COLD RIGHT FOOT. A CTA WAS PERFORMED; AND THE CONTRALATERAL LIMB WAS FOUND TO HAVE THROMBOSED WITH MONOPHASIC (50-99% DIAMETER STENOSIS) FLOW IN THE COMMON FEMORAL ARTERY. THE PHYSICIAN ELECTED TO PERFORM AN EMBOLECTOMY AND PLACED ANOTHER MANUFACTURER'S STENT INSIDE THE LIMB, WHICH SUCCESSFULLY RESOLVED THE LIMB OCCLUSION. IT WAS ALSO NOTED THAT THE ENDOLEAK HAD RESOLVED WITHOUT INTERVENTION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT ABDOMINAL STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00871044

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention