BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RANGER PACLITAXEL-COATED PTA BALLOON CATHETER

    MDR report key: 15506397 · Received September 29, 2022

    Report

    Report Number
    2124215-2022-35047
    Event Type
    Injury
    Date Received
    September 29, 2022
    Date of Event
    July 28, 2022
    Report Date
    September 28, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    ONU
    UDI-DI
    08714729976141
    PMA / PMN Number
    P190019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6).

    Description of Event or Problem · 0

    ELEGANCE STUDY. IT WAS REPORTED THAT THE PATIENT EXPERIENCED CLAUDICATION RELATED TO WORSENING ISCHEMIA OF THE TARGET VESSEL. THE SUBJECT UNDERWENT TREATMENT WITH THREE RANGER DRUG COATED BALLOONS ON (B)(6) 2021 AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE TARGET LESION WAS IN THE LEFT PROXIMAL COMMON FEMORAL ARTERY AND FEMORAL-ANTERIOR TIBIAL BYPASS WITH PROXIMAL REFERENCE VESSEL DIAMETER OF 10 MM AND DISTAL REFERENCE VESSEL DIAMETER OF 5 MM. THE LESION WAS CLASSIFIED AS TASC II D, WITH A LENGTH OF 360 MM AND 90% STENOSIS. PRIOR TO TARGET LESION TREATMENT, BALLOON DILATATION WAS PERFORMED USING 3.0 MM X 40 MM STERLING PTA BALLOON. THE TREATMENT OF TARGET LESION WAS PERFORMED BY DILATATION USING STUDY DEVICES 5 MM X 40 MM, 6 MM X 100 MM AND 6 MM X 200 MM RANGER DRUG COATED BALLOONS. FOLLOWING POST DILATATION WAS PERFORMED WITH 7.0 MM X 220 MM STERLING PTA BALLOON AND THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 10%. ON (B)(6) 2022, SUBJECT WAS NOTED WITH THE CLAUDICATION SYMPTOMS RELATED TO WORSENING ISCHEMIA NOTED IN BILATERAL LOWER EXTREMITY. ON THE SAME DAY, SUBJECT UNDERWENT LEFT LOWER EXTREMITY DUPLEX WHICH REVEALED THAT THE LEFT EXTERNAL ILIAC ARTERY WAS PATENT, COMMON FEMORAL ARTERY HAD MURAL THROMBUS, FEMORAL-ANTERIOR TIBIAL BYPASS GRAFT PROXIMAL ANASTOMOTIC SITE WAS 50-99% STENOSIS, AND THE PROXIMAL ANTERIOR TIBIAL ARTERY WAS PATENT. ON (B)(6) 2022, 255 DAYS POST INDEX PROCEDURE, 80% STENOSIS NOTED AT THE PROXIMAL ANASTOMOSIS AND PROXIMAL BYPASS GRAFT WERE TREATED BY BALLOON ANGIOPLASTY USING 5 MM X 150 MM RANGER DRUG COATED BALLOONS. POST INTERVENTION, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 20%.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2934111 RANGER PACLITAXEL-COATED PTA BALLOON CATHETER DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER ONU BOSTON SCIENTIFIC CORPORATION 1973-03 0027490714 08714729976141

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Required Intervention