BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELIANT STENT GRAFT BALLOON CATHETER -US

    MDR report key: 2191909 · Received July 22, 2011

    Report

    Report Number
    2953200-2011-01316
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 23, 2011
    Report Date
    June 23, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR IRELAND
    Product Code
    DQY
    PMA / PMN Number
    K050038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: ENDOLEAK. RESULTS AND CONCLUSION: AGGRESSIVE BALLOONING.

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A 34MM DIAMETER RIGHT COMMON ILIAC ANEURYSM. VESSEL MORPHOLOGY WAS REPORTED AS UNREMARKABLE EXCEPT FOR A SMALL AREA OF FOCAL STENOSIS ON THE RIGHT (CONTRALATERAL) SIDE. THE BIFURCATED STENT GRAFT WAS IMPLANTED ON THE LEFT SIDE, FOLLOWED BY THE MAIN CONTRALATERAL LIMB (REF MFR #2953200-2011-01314) AND A (REF MFR #2953200-2011-01315) ON THE RIGHT SIDE, WITH A 3 - 4CM OVERLAP BETWEEN THESE TWO DEVICES. ON THE FINAL ANGIOGRAM RUN THERE WAS A SMALL TYPE 3 ENDOLEAK COMING FROM THE JUNCTION BETWEEN THE TWO DEVICES. THIS AREA WAS BALLOONED VERY AGGRESSIVELY WITH A RELIANT BALLOON USING A 35 CC SYRINGE. IT IS UNK HOW MUCH FLUID WAS INJECTED, BUT THE INJECTION WAS RAPID AND THE BALLOON ELONGATED DURING THE PROCESS AND RUPTURED (REF MFR (B)(4), 2953200-2011-01316). THERE WAS NO FABRIC TEAR OR VESSEL RUPTURE; HOWEVER, THE ENDOLEAK DID NOT RESOLVE. AN ILIAC ENLW1613C82E WAS USED TO RELINE THE JUNCTION AREA AND SUCCESSFULLY RESOLVED THE ENDOLEAK. NO CLINICAL SEQUELAE WAS REPORTED AND THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RELIANT STENT GRAFT BALLOON CATHETER -US DQY MEDTRONIC CARDIOVASCULAR IRELAND NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention