BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELIANT BALLOON

    MDR report key: 3213921 · Received July 9, 2013

    Report

    Report Number
    2953200-2013-01287
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 13, 2013
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    DQY
    PMA / PMN Number
    K050038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS AND CONCLUSIONS: (HIGHLY ANGULATED PROXIMAL AORTIC NECK). (SUPRARENAL STENTS OF STENT GRAFT). (BALLOON RUPTURE).

    Description of Event or Problem · 1

    AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. THE MAXIMUM ANEURYSM DIAMETER WAS APPROXIMATELY 10 CM. THE PROXIMAL AORTIC NECK WAS 1.5-2.0 CM LONG, AND THE INFRARENAL NECK ANGLE WAS 90 DEGREES. THE ILIAC ARTERIES WERE REPORTED TO BE NORMAL AND UNREMARKABLE. IT WAS REPORTED THAT INTRA-OPERATIVELY, FOLLOWING DEPLOYMENT OF THE STENT GRAFTS, ANOTHER MANUFACTURER¿S BALLOON AND A RELIANT BALLOON WERE USED TO EXPAND THE PROXIMAL END OF THE BIFURCATED STENT GRAFT. BOTH BALLOONS RUPTURED, AND IT WAS DETERMINED THAT ONE OF THE SUPRARENAL STENTS HAD FOLDED INWARD. THE PHYSICIAN DEPLOYED A CUFF, AND THE METAL SUPRARENAL STENTS BECAME ENTANGLED WITH THE DELIVERY SYSTEM. THE DELIVERY SYSTEM WAS SUCCESSFULLY REMOVED, BUT THE SUPRARENAL STENTS OF THE MAIN BODY AND CUFF WERE FOLDED INWARD. ANOTHER RELIANT BALLOON WAS USED AND THE ISSUE WAS PARTIALLY CORRECTED; HOWEVER, THE BARE METAL STENTS WERE STILL PARTIALLY FOLDED INWARD. A TYPE II ENDOLEAK WAS ALSO NOTED, BUT THERE WAS NO EVIDENCE OF OTHER ENDOLEAKS. THERE WERE NO DIFFICULTIES WITH THE DEPLOYMENT OF THE BIFURCATED STENT GRAFT, BUT IT WAS MEETING SOME RESISTANCE DURING REMOVAL AT THE PROXIMAL SUPRARENAL AREA. THE PHYSICIAN COMMENTED THAT THE ANGULATED PROXIMAL AORTA WAS THE LIKELY CAUSE OF THE ISSUE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313398 RELIANT BALLOON CATHETER, PERCUTANEOUS DQY MEDTRONIC CARDIOVASCULAR 0006678762

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention