BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RANGER PACLITAXEL-COATED PTA BALLOON CATHETER

    MDR report key: 17572626 · Received August 18, 2023

    Report

    Report Number
    2124215-2023-43884
    Event Type
    Injury
    Date Received
    August 18, 2023
    Date of Event
    July 20, 2023
    Report Date
    August 18, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    ONU
    UDI-DI
    08714729976042
    PMA / PMN Number
    P190019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT RESTENOSIS OCCURRED. ON (B)(6) 2022, A BOSTON SCIENTIFIC PATHWAYS ATHERECTOMY DEVICE AND RANGER PACLITAXEL-COATED PTA BALLOON CATHETER 5.0 X 200MM WAS SELECTED TO TREAT SEVERE DISEASE THROUGHOUT THE ENTIRE LENGTH OF THE SUPERFICIAL FEMORAL ARTERY WITH TOTAL OCCLUSION THROUGH THE MIDPORTION AND THROUGH HUNTER'S CANAL. THE ENTIRE ABOVE-KNEE POPLITEAL AND SUPERFICIAL FEMORAL ARTERIES WERE SERIALLY DILATED. EACH INFLATION WAS TAKEN TO NOMINAL PRESSURE AND COMPLETE EXPANSION WAS OBTAINED. FOLLOWING THE SERIAL DILATATION REPEAT ANGIOGRAM SHOWED FOCAL DISSECTIONS SO THE AREA WAS THEN RE-DILATED FROM THE ENTIRE ABOVE-KNEE POPLITEAL TO THE SUPERFICIAL FEMORAL ORIGIN AND EACH INFLATION HELD FOR A FULL 5 MINUTES. FOLLOWING THIS THE DISSECTIONS WERE IMPROVED AND NOT FLOW LIMITING, AND BECAUSE OF HER VERY SMALL VESSELS IT WAS FELT THAT WE SHOULD AVOID STENTS IF POSSIBLE. THESE FINDINGS WERE ACCEPTED BY THE PHYSICIAN. THE GUIDEWIRE AND SHEATH WERE REMOVED, A STAR CLOSE DEVICE WAS DEPLOYED WITH EXCELLENT HEMOSTASIS AND THE PATIENT WAS TAKEN RECOVERY AREA IN STABLE CONDITION. SHE TOLERATED THE PROCEDURE WELL. WIDE PATENCY WAS RE-STORED WITH GOOD FLOW TO THE FOOT. THE PATIENT WAS TO RETURN IN ONE WEEK FOR FOLLOW-UP ULTRASOUND AND WE LIKELY WILL GET HER SCHEDULED FOR INTERVENTION OF THE RIGHT LEG AT THAT TIME. ON (B)(6) 2023, FOLLOW-UP ANGIOGRAM REVEALED BILATERAL LOWER EXTREMITY CLAUDICATION AND HIGH-GRADE RESTENOSIS IN THE LEFT COMMON FEMORAL ARTERY WITH FLUSH OCCLUSION OF THE SUPERFICIAL FEMORAL ARTERY. THIS CONTINUED TO JUST BELOW HUNTER'S CANAL WHERE THERE WAS CONSTITUTION OF THE POPLITEAL ARTERY. THE ABOVE-KNEE AND BELOW-KNEE POPLITEAL ARTERY APPEARED NORMAL. A BOSTON SCIENTIFIC ATHERECTOMY DEVICE WITH A 2.0 MM BURR WAS SELECTED DUE TO THE COMPLEX NATURE OF THE PROCEDURE. THE REPEAT ANGIOGRAM SHOWED A NICE CHANNEL BUT WITH IRREGULARITY THROUGH HUNTER'S CANAL. A 5 X 200 BALLOON WAS THEN USED TO DILATE THE ENTIRE LENGTH OF THE SUPERFICIAL FEMORAL ARTERY AND THE PROXIMAL POPLITEAL ARTERY EACH INFLATION BEING TAKEN TO NOMINAL PRESSURE. EACH INFLATION HELD FOR 3 MINUTES, DEFLATED AND THEN REMOVED. REPEAT ANGIOGRAM SHOWED PERSISTENT DISSECTION THROUGH HUNTER'S CANAL, SO PLACEMENT OF A 6 X 60 DRUG-COATED ELUVIA STENT WAS USED TO TREAT THE DISSECTION. THE STENT WAS DEPLOYED IN EXCELLENT POSITION AND THEN POST-DILATED WITH THE 5MM BALLOON. REPEAT ANGIOGRAM SHOWED WIDE PATENCY THROUGH THE SUPERFICIAL FEMORAL ARTERY WITH BRISK FLOW DISTALLY. AFTER ALSO TREATING THE DISTAL ANTERIOR TIBIAL AND DORSALIS PEDIS ARTERY, A STAR CLOSE DEVICE WAS DEPLOYED AT THE RIGHT FEMORAL PUNCTURE SITE WITH EXCELLENT HEMOSTASIS AND THE PATIENT WAS TAKEN TO THE RECOVERY AREA IN STABLE CONDITION. SHE TOLERATED THE PROCEDURE. THE PLAN WAS TO HAVE THE PATIENT RETURN IN ONE WEEK WITH FOLLOW-UP ULTRASOUND AND WAS ALREADY TAKING ASPIRIN AND PLAVIX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2127196 RANGER PACLITAXEL-COATED PTA BALLOON CATHETER DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER ONU BOSTON SCIENTIFIC CORPORATION 1973-03 01294H22 08714729976042

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Required Intervention