BEUDAMED
    FDA Adverse Event Death Summary report: N

    IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER

    MDR report key: 6957236 · Received October 17, 2017

    Report

    Report Number
    9612164-2017-01474
    Event Type
    Death
    Date Received
    October 17, 2017
    Date of Event
    July 12, 2017
    Report Date
    October 17, 2017
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    ONU
    PMA / PMN Number
    P140010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE IS LITERATURE ARTICLE PUBLISHED DATE PACLITAXEL-COATED BALLOONS DO NOT PREVENT RECURRENT STENOSIS IN HEMODIALYSIS ACCESS FISTULAE: RESULTS OF A RANDOMIZED CLINICAL TRIAL DOI:10.23736/S1824-4777.17.01282-7 HTTP://WWW.MINERVAMEDICA.IT. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THIS STUDY WAS DONE TO COMPARE SECONDARY PATENCY RATES OF PACLITAXEL-COATED BALLOONS (PCB) TO CONVENTIONAL BALLOON ANGIOPLASTY (CBA) IN RECURRENT STENOSIS IN HEMODIALYSIS FISTULA. THIRTY FOUR PATIENTS WERE TREATED WITH A MEDTRONIC PACLITAXEL COATED BALLOON, USED WITH A 6F SHEATH, THE MAXIMUM INFLATION PRESSURE WAS 16 BAR, WITH AN INFLATION TIME OF 1MIN. THE PATIENTS ATTENDED FOLLOW-UP ULTRASOUND EXAMINATIONS AT 3,6,12 AND 24 MONTHS. IT WAS REPORTED 29 PATIENTS HAD ARTERIOVENOUS FISTULA (AVF) AND 5 HAD AN ARTERIOVENOUS GRAFT (AVG). ONE PATIENT IN THE CONTROL GROUP HAD A SUBTOTAL OCCLUSION A FEW HOURS AFTER INTERVENTION, THE CAUSE IS NOT CLEAR. ONE PATIENT HAD AN EARLY COMPLICATION WITH THROMBOSIS OF THE FISTULA DUE TO AN ALLERGIC REACTION TO THE CONTRAST AGENT, THE CEPHALIC VEIN WAS OCCLUDED, AND A SURGICAL REVISION WAS NECESSARY. ONE PATIENT IN THE CONTROL GROUP RECEIVED A KIDNEY TRANSPLANT AFTER ALMOST 2 YEARS AND WAS NOT AVAILABLE FOR FOLLOW-UP AND 3 DEATHS WERE REPORTED. IT WAS CONCLUDED THAT THIS STUDY DOES NOT SUPPORT THE USE OF PCBS TO PREVENT RECURRENT STENOSIS IN HEMODIALYSIS FISTULAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733508 IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER ONU MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death