BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERLING

    MDR report key: 23839119 · Received December 18, 2025

    Report

    Report Number
    2124215-2025-91724
    Event Type
    Injury
    Date Received
    December 18, 2025
    Date of Event
    November 1, 2021
    Report Date
    December 18, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LIT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A2 - AGE AT TIME OF EVENT: 62 YEARS OLD (AT THE TIME OF ENROLLMENT). DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. BECAUSE THE PRODUCT IS UNKNOWN, WE ARE UNABLE TO PROVIDE THE UNIQUE IDENTIFIER (UDI) # AND OTHER SPECIFIC PRODUCT INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PERFORATION AND FISTULA OCCURRED. THE SUBJECT UNDERWENT TREATMENT WITH THE RANGER DRUG-COATED BALLOON AND ELUVIA DRUG-ELUTING STENTS ON (B)(6) 2021 AS PART OF THE CLINICAL TRIAL. TARGET LESION #001 WAS LOCATED IN THE RIGHT MID SUPERFICIAL FEMORAL ARTERY (SFA), RIGHT DISTAL SFA, AND RIGHT MID POPLITEAL ARTERY, WITH A PROXIMAL REFERENCE VESSEL DIAMETER OF 6 MM, A DISTAL REFERENCE VESSEL DIAMETER OF 5 MM, A LESION LENGTH OF 240 MM, AND 90% STENOSIS. THE LESION WAS CLASSIFIED AS A TASC II B LESION. PRIOR TO TREATMENT OF THE TARGET LESION, BALLOON DILATION WAS PERFORMED USING 4 MM X 100 MM AND 4 MM X 80 MM STERLING OTW PTA BALLOONS. TREATMENT CONSISTED OF DILATION WITH A 5 MM X 40 MM RANGER DRUG-COATED BALLOON STUDY DEVICE, FOLLOWED BY PLACEMENT OF 6 MM X 120 MM AND 6 MM X 80 MM ELUVIA DRUG-ELUTING STENT STUDY DEVICES. POST-TREATMENT DILATION WAS PERFORMED USING A 6 MM X 100 MM MUSTANG OTW PTA BALLOON, AND THE FINAL RESIDUAL STENOSIS WAS DOCUMENTED AS 0%. ON (B)(6) 2021, THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL ON DUAL ANTIPLATELET THERAPY. PER BASELINE CORE LAB FORM DATED (B)(6) 2021, DURING THE INDEX PROCEDURE FOR TREATMENT OF TARGET LESION #001, POST-STUDY DEVICE ANALYSIS OF THE DRUG-ELUTING STENT REVEALED A COMPLICATION OF PERFORATION AND ARTERIOVENOUS FISTULA IN THE RIGHT DISTAL SUPERFICIAL FEMORAL ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2241598 STERLING CATHETER, PERCUTANEOUS LIT BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other