BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT ILIAC STENT GRAFT

    MDR report key: 2180939 · Received July 22, 2011

    Report

    Report Number
    2953200-2011-01313
    Event Type
    Injury
    Date Received
    July 22, 2011
    Date of Event
    June 22, 2011
    Report Date
    June 23, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL RESULTS AND CONCLUSION: IMPROPER CANNULATION OF GATE LED TO TWISTING. PRE-OPERATIVE RUPTURE. OCCLUSION, FEVER.

    Description of Event or Problem · 1

    AN ENDURANT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN EMERGENT CONTAINED RUPTURE, ONE MONTH AGO. THE CONTRALATERAL LIMB WAS ROTATED ANTERIORLY UPON DEPLOYMENT. NO COMPLICATIONS OR ENDOLEAKS WERE NOTED. A POST-OPERATIVE ANGIOGRAM SHOWED GOOD FLOW IN BOTH LIMBS AND THE EXTERNAL VESSELS. THE ANEURYSM WAS 53.2 X 54.8MM. VESSEL MORPHOLOGY WAS REPORTED AS NO TORTUOSITY AND A SMALL AMOUNT OF CALCIFICATION IN THE ILIACS. IT WAS REPORTED THAT THE PT PRESENTED WITH CLAUDICATION AND A FEVER. THE CT SHOWED NARROWING OF THE LIMB AT THE LEVEL OF OVERLAP WITH THE CONTRALATERAL GATE. IT WAS DISCOVERED THAT AT THE TIME OF THE IMPLANT, THE CONTRALATERAL CANNULATION WAS IMPROPERLY PERFORMED, AS THE WIRE MUST HAVE ACCIDENTALLY TWISTED AROUND THE IPSILATERAL LIMB (REF MFR #2953200-2011-01312), POSTERIORLY, THEN ANTERIORLY, PRIOR TO CANNULATION OF THE GATE, RESULTING IN THE CONTRALATERAL LIMB (REF MFR #2953200-2011-01313) BEING COMPLETELY TWISTED AROUND THE IPSILATERAL LIMB. THE PT'S FEVER LASTED A FEW DAYS, DURING WHICH FIVE BLOOD CULTURES WERE TAKEN. ONE CULTURE SHOWED SKIN ORGANISMS, WHICH HAS SINCE RESOLVED. THE PT WILL BE ON LIFETIME ANTIBIOTICS. THE PT IS UNDERGOING CHEMOTHERAPY FOR COLON AND METASTATIC LIVER CANCER. AS THE PARTIAL OCCLUSION IS NO LONGER CAUSING CLAUDICATION, THE PT PREFERS NOT TO HAVE ANY INTERVENTION AT THIS TIME, SO THAT CHEMOTHERAPY CAN RESUME. AN INTERNAL FILM REVIEW SHOWED THE CONTRALATERAL LIMB OCCLUDED BEGINNING AT THE FLOW DIVIDER, WHERE THE LIMB IS SOMEWHAT CRUSHED (11-12MM DIAMETER). THE CONTRALATERAL LIMB IS TWISTED AROUND THE IPSILATERAL LIMB WITHIN THE SAC (APPROXIMATELY 360 DEGREES), AND THERE IS BLOOD FLOW BEGINNING AT THE ILIAC BIFURCATION. THE IPSILATERAL LIMB IS NOT OCCLUDED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT ILIAC STENT GRAFT MIH MEDTRONIC CARDIOVASCULAR IRELAND NA V00846250

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR