BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RANGER

    MDR report key: 22457209 · Received July 9, 2025

    Report

    Report Number
    2124215-2025-45371
    Event Type
    Injury
    Date Received
    July 9, 2025
    Date of Event
    May 21, 2025
    Report Date
    July 9, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    ONU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3 - DATE OF EVENT: THE EVENT DATE WAS ESTIMATED TO THE DATE THAT THE JOURNAL ARTICLE WAS PUBLISHED. DETAILED PRODUCT OR INITIAL REPORTER INFORMATION WAS NOT PROVIDED TO BSC. BASED ON THE NATURE OF THE INFORMATION PROVIDED TO BSC, IT IS NOT POSSIBLE TO PERFORM A GOOD FAITH EFFORT TO OBTAIN ADDITIONAL INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. XHEPA, G.; INZERILLO, A.; CONSTANTINESCU, I.; FAERBER, P.; GLEYZOLLE, A.; BIONDETTI, P.; DEL GRANDE, F.; XHEPA, E.; MORTELLARO, S.; CARRAFIELLO, G.; ET AL. LIMUS DEVICES FOR THE TREATMENT OF SFA: LATEST OUTCOMES AND FUTURE PERSPECTIVES. J. CLIN. MED. 2025, 14, 3594. HTTPS://DOI.ORG/10.3390/JCM14103594.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA ATTACHED LITERATURE REVIEW THAT STUDY SUBJECTS TREATED WITH RANGER EXPERIENCED LOSS OF PATENCY (RESTENOSIS) AND REQUIRED ADDITIONAL INTERVENTION IN THE FORM OF TARGET LESION REVASCULARIZATION (TLR). THE LITERATURE REVIEW FOCUSED ON DRUG-ELUTING BALLOONS AND STENTS USED TO TREAT PERIPHERAL ARTERY DISEASE (PAD). AS A PART OF THIS REVIEW, THE AUTHORS IDENTIFIED STUDIES INVOLVING PERCUTANEOUS TREATMENT OF THE SUPERFICIAL FEMORAL ARTERY (SFA) AND/OR POPLITEAL ARTERY, WITH A FOCUS ON CLINICAL OUTCOMES, FOLLOW-UP DATA, AND COMPLICATIONS, INCLUDING ONLY FULL-TEXT PUBLICATIONS IN ENGLISH FROM JANUARY 2000 TO SEPTEMBER 2023. ULTIMATELY, A TOTAL OF 15 STUDIES FULFILLED ALL ELIGIBILITY CRITERIA AND WERE INCLUDED IN THIS REVIEW. OF THESE 15 STUDIES, THERE WAS ONE NON-BSC SPONSORED STUDY WITH RELEASED RESULTS THAT MENTIONED USE OF THE RANGER. THE COMPARE TRIAL COMPARED TWO PACLITAXEL-COATED BALLOONS (IN.PACT AND RANGER) IN 414 PATIENTS. THE PRIMARY PATENCY RATES FOR RANGER WERE AS FOLLOWS: 12 MONTHS (83%) AND 24 MONTHS (65.5%). TLR RATES FOR RANGER WERE AS FOLLOWS: 6 MONTHS (2.5%), 12 MONTHS (9.5%), AND 24 MONTHS (17.3%).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    923888 RANGER CATHETER, PERCUTANEOUS ONU BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| O