BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 25053338 · Received April 30, 2026

    Report

    Report Number
    2124215-2026-23686
    Event Type
    Injury
    Date Received
    April 30, 2026
    Date of Event
    July 5, 2025
    Report Date
    April 30, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MCX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3 DATE OF EVENT: DATE OF PUBLICATION. 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. YASUHIRO HONDA, KENSAKU NISHIHIRA, NEHIRO KURIYAMA, MAKOTO TAKAMATSU, KEISUKE YAMAMOTO, SHUN NISHINO, KOSUKE KADOOKA, TAKEAKI KUDO, KENJI OGATA, TOSHIYUKI KIMURA, KENGO AYABE, KEIICHI ASHIKAGA, YOSHISATO SHIBATA, COMPARISON OF SHORT-TERM CLINICAL OUTCOMES BETWEEN INTRAVASCULAR LITHOTRIPSY AND ROTATIONAL ATHERECTOMY FOR CALCIFIED CORONARY STENOSIS IN PATIENTS WITH ACUTE CORONARY SYNDROME, CIRCULATION REPORTS, 2025, VOLUME 7, ISSUE 8, PAGES 612-618, RELEASED ON J-STAGE AUGUST 08, 2025, ADVANCE ONLINE PUBLICATION JULY 05, 2025, ONLINE ISSN 2434-0790, HTTPS://DOI.ORG/10.1253/CIRCREP.CR-25-0086, HTTPS://WWW.JSTAGE.JST.GO.JP/ARTICLE/CIRCREP/7/8/7_CR-25-0086/_ARTICLE/-CHAR/EN.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LITERATURE ARTICLE THAT PATIENT COMPLICATIONS OCCURRED. THE OPTIMAL REVASCULARIZATION STRATEGY FOR CALCIFIED LESIONS IN PATIENTS WITH ACUTE CORONARY SYNDROME (ACS) REMAINS UNCLEAR. THIS STUDY AIMED TO COMPARE THE SHORT TERM OUTCOMES OF INTRAVASCULAR LITHOTRIPSY (IVL) AND ROTATIONAL ATHERECTOMY (RA) FOR PATIENTS WITH ACS RESULTING FROM CALCIFIED LESIONS. AMONG 3,556 CONSECUTIVE PATIENTS WITH ACS WHO UNDERWENT PRIMARY PERCUTANEOUS CORONARY INTERVENTION (PCI) BETWEEN 2016 AND 2024, 52 PATIENTS WERE RETROSPECTIVELY ANALYZED WHO RECEIVED DRUG ELUTING STENTS WITH EITHER IVL (N=24) OR RA (N=28) FOR CALCIFIED LESIONS. THE PRIMARY OUTCOME WAS THE INCIDENCE OF MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE). IN ADDITION, WE EVALUATED SLOW FLOW OR NO REFLOW PHENOMENA INCIDENCE DURING PCI AND THE PROCEDURAL SUCCESS RATE. COMPARED WITH PATIENTS WITH RA, THOSE WITH IVL HAD A SMALLER PREPROCEDURAL MINIMUM LUMEN DIAMETER AND A LARGER PREPROCEDURAL REFERENCE VESSEL DIAMETER. PRIMARY OUTCOMES AND PROCEDURAL SUCCESS RATES WERE COMPARABLE BETWEEN BOTH GROUPS. HOWEVER, THE SLOW FLOW OR NO REFLOW INCIDENCE WAS SIGNIFICANTLY LOWER IN THE IVL GROUP THAN IN THE RA GROUP. AFTER ADJUSTING FOR CONFOUNDERS, IVL WAS INDEPENDENTLY ASSOCIATED WITH A LOWER SLOW FLOW OR NO REFLOW INCIDENCE. RA WAS PERFORMED USING A ROTABLATOR SYSTEM (BOSTON SCIENTIFIC (BSC)). THE PROCEDURE BEGAN WITH THE SMALLEST AVAILABLE ROTABLATION BURR (1.25, 1.5, OR 1.75 MM). BURR SPEEDS RANGED FROM 160,000 TO 220,000 RPM, WITH EACH RUN LASTING APPROXIMATELY 20 TO 30 S. IN ALL PROCEDURES, AN INTRACORONARY CONTINUOUS INFUSION OF HEPARIN, VERAPAMIL, AND ISOSORBIDE DINITRATE WAS ADMINISTERED VIA THE BURR SHEATH. SLOW FLOW OR NO REFLOW DURING PCI PROCEDURE WAS OBSERVED IN 13 CASES IN RA GROUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408208 ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other