BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELIANT STENT GRAFT BALLOON CATHETER

    MDR report key: 1425361 · Received July 30, 2009

    Report

    Report Number
    2953200-2009-01022
    Event Type
    Injury
    Date Received
    July 30, 2009
    Date of Event
    June 30, 2009
    Report Date
    June 30, 2009
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    DQY
    PMA / PMN Number
    K050038
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION CODES, METHOD: OTHER (CD EVALUATION).

    Description of Event or Problem · 1

    A TALENT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A 5 CM ABDOMINAL AORTIC ANEURYSM. VESSEL MORPHOLOGY WAS REPORTED AS MODERATE CALCIFICATION AND MILD TORTUOSITY. AFTER THE SUCCESSFUL DEPLOYMENT OF THE STENT GRAFT THE PHYSICIAN ELECTED TO IMPLANT A CARDIOMEMES DEVICE. THE RELIANT BALLOON WAS INFLATED WITH EXCESSIVE FORCE BY THE TECHNICIAN. (MFR REPORT# 2952300-2009-01021) UPON FINAL ANGIOGRAM THERE WAS A LARGE TYPE III ENDOLEAK.THERE WAS A LARGE HOLE AT THE BIFURCATION OF THE STENT GRAFT. (SLIGHTLY LOWER THEN THE FLOW DIVIDER). THE PHYSICIAN IMPLANTED A TALENT IXW1616C80XH DEVICE UP THE RIGHT SIDE INSIDE ON THE IPSILATERAL SIDE OF THE BIFURCATED STENT GRAFT AND THE TYPE III ENDOLEAK CONTINUED. THE PHYSICIAN PLACED A IW1416C75XH UP THE LEFT SIDE AND PERFORMED AN ANGIOGRAM. THERE IS STILL AT TYPE III ENDOLEAK. THE DECISION WAS MADE TO MONITOR THE PT SINCE THE PT WAS NOT A SURGICAL CANDIDATE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PT IS FINE. FILMS WERE RECEIVED AND THEIR INTERPRETATION HAS BEEN COMPLETED BY A CONSULTANT PHYSICIAN. THE REVIEW OF A SERIES OF 39 ARTERIOGRAMS. THERE IS MILD ECTASIA OF THE RIGHT AND LEFT COMMON ILIAC ARTERIES. THERE ARE SMALL AREAS OF STENOSIS. THE RIGHT AND LEFT RENAL ARTERIES ARE PATENT. THE DISTANCE FROM THE LOWEST RENAL TO THE AORTIC BIFURCATION IS 11 CM. THE LEFT RENAL IS THE LOWEST. THE TALENT STENT GRAFT IS PLACED UP THE RIGHT SIDE. THE STENT GRAFT IS PLACED JUST BELOW THE LOWEST RENAL ARTERY. THE CONTRALATERAL GATE IS OPENED. A CARDIOMEMS DEVICE IS PLACED. THE GATE IS CANNULATED. LIMBS ARE DEPLOYED INTO THE ILIAC ARTERIES. THE RELIANT BALLOON IS INFLATED. ALONG THE LIMB IT APPEARS TO BE OVERINFLATED AT TIMES. COMPLETION ANGIOGRAM REVEALS LARGE PROBABLE TYPE III ENDOLEAK. CATHETER IN BODY OF GRAFT WITH EXTRAVASATION OF CONTRAST. LIMBS ARE DEVELOPED INSIDE THE OTHER LIMBS. REPEAT ANGIO REVEALS CONTINUED TYPE III ENDOLEAK BUT OVERALL IMPROVED. THE CONSULTANT PHYSICIAN'S IMPRESSION IS AS FOLLOWS. THERE IS A TYPE III ENDOLEAK FROM OVER INFLATION OF THE RELIANT BALLOON. THIS WAS TREATED WITH RELINING OF THE LIMBS. THE TEAR MAY BE AT THE FLOW DIVIDER WHICH MAY REQUIRE PLACEMENT OF AN AUI DEVICE WITH FEM-FEM BYPASS IF IT DOES NOT RESOLVE OR THERE IS ANEURYSM SAC GROWTH. WOULD REPEAT CTA AT A MONTH TO EVALUATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RELIANT STENT GRAFT BALLOON CATHETER DQY MEDTRONIC CARDIOVASCULAR SANTA ROSA NA 0001007384

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention