BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RANGER SL

    MDR report key: 18366147 · Received December 20, 2023

    Report

    Report Number
    2124215-2023-72167
    Event Type
    Injury
    Date Received
    December 20, 2023
    Date of Event
    January 12, 2023
    Report Date
    November 21, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    ONU
    UDI-DI
    08714729830801
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1: PATIENT IDENTIFIER: (B)(6). A2: AGE AT TIME OF EVENT: 83 YEARS OLD AT THE TIME OF STUDY ENROLLMENT.

    Description of Event or Problem · 0

    ELEGANCE CLINICAL TRIAL IT WAS REPORTED THAT RESTENOSIS OCCURRED. THE SUBJECT UNDERWENT TREATMENT WITH THE RANGER DRUG COATED BALLOONS ON 15-JUN-2022 AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE TARGET LESION WAS IN THE RIGHT ANTERIOR TIBIAL ARTERY WITH 3.5 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 2 MM DISTAL REFERENCE VESSEL DIAMETER WITH LESION LENGTH 320 MM WITH 100% STENOSIS AND WAS CLASSIFIED AS TASC II C LESION. PRIOR TO THE TARGET LESION TREATMENT WITH THE STUDY DEVICE, PRE-DILATION WAS PERFORMED USING 2 MM X 150 MM COYOTE PTA BALLOON. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION USING STUDY DEVICES, 2.5 MM X 120 MM, 3 MM X 120 MM AND 3.5 MM X 150 MM RANGER DRUG COATED BALLOONS. FOLLOWING TREATMENT, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 15%. ON THE (B)(6) 2022, THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL ON DUAL ANTIPLATELET THERAPY. ON 02-MAR-2023, SUBJECT WAS NOTED WITH SYMPTOMS RELATED TO RESTENOSIS OF RIGHT ANTERIOR TIBIAL ARTERY AND WAS HOSPITALIZED FOR FURTHER EVALUATION AND TREATMENT. ON 03-MAR-2023, 261 DAYS POST INDEX PROCEDURE, 70% STENOSIS NOTED IN THE RIGHT ANTERIOR TIBIAL ARTERY WAS TREATED WITH BALLOON DILATION USING COYOTE PTA BALLOON. POST TREATMENT, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 0%. ON THE SAME DAY, THE EVENT WAS CONSIDERED TO BE RESOLVED AND ON (B)(6) 2023, THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2163705 RANGER SL CATHETER, PERCUTANEOUS ONU BOSTON SCIENTIFIC CORPORATION 1584-01 07316H21 08714729830801

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| R