BEUDAMED
    FDA Adverse Event Death Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 25045438 · Received April 30, 2026

    Report

    Report Number
    2124215-2026-23415
    Event Type
    Death
    Date Received
    April 30, 2026
    Date of Event
    July 14, 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: LITERATURE ARTICLE PUBLICATION DATE. E1 INITIAL REPORTER FACILITY NAME: (B)(6). E1 INITIAL REPORTER PHONE: (B)(6). 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. SAKAMOTO, Y., KAWAMORI, H., TOBA, T. ET AL. PROGNOSTIC SIGNIFICANCE OF ANGIOGRAPHY-DERIVED INDEX OF MICROCIRCULATORY RESISTANCE ASSESSMENT AFTER ROTATIONAL ATHERECTOMY IN PATIENTS WITH SEVERELY CALCIFIED LESIONS. HEART VESSELS 40, 1079 1091 (2025). HTTPS://DOI.ORG/10.1007/S00380-025-02575-X.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LITERATURE ARTICLE THAT PATIENT DEATH OCCURRED. CORONARY MICROCIRCULATORY DYSFUNCTION (CMD) IS A KNOWN PREDICTOR OF ADVERSE OUTCOMES AFTER PERCUTANEOUS CORONARY INTERVENTION (PCI). HOWEVER, THE PROGNOSTIC SIGNIFICANCE OF CMD IN PATIENTS WITH SEVERELY CALCIFIED LESIONS TREATED WITH ROTATIONAL ATHERECTOMY (RA) REMAINS UNCLEAR. A RETROSPECTIVE STUDY OF CONSECUTIVE CHRONIC CORONARY SYNDROME PATIENTS WHO UNDERWENT PCI WITH RA FOLLOWED BY SECOND GENERATION DRUG ELUTING STENT (DES) IMPLANTATION. CMD WAS EVALUATED BY ANGIOGRAPHY DERIVED INDEX OF MICROCIRCULATORY RESISTANCE (IMRANGIO), CALCULATED FROM THE QUANTITATIVE FLOW RATIO (QFR) OBTAINED IMMEDIATELY AFTER PCI WITHOUT HYPEREMIA. RA PROCEDURES WERE PERFORMED USING THE ROTABLATOR SYSTEM (BOSTON SCIENTIFIC) AT A ROTATION SPEED OF 140,000 TO 200,000 RPM, ACCORDING TO STANDARD PRACTICE. THE CHOICE OF THE WIRE TYPE, STARTING SPEED, INITIAL BURR SIZE, AND BURR SIZE-UP WAS AT THE OPERATOR DISCRETION. A DRUG COCKTAIL CONTAINING HEPARIN, ATROPINE, NITROGLYCERIN, AND NICORANDIL WAS ADMINISTERED INTO THE CORONARY ARTERY VIA AN RA CATHETER TO PREVENT THE SLOW FLOW PHENOMENON. EACH RUN WAS PERFORMED WITHIN 30 S, AVOIDING EXCESSIVE SPEED DOWN OF LESS THAN 5,000 RPM. THE BURR WAS REMOVED AFTER PASSING THROUGH THE LESION. THE PRIMARY OUTCOME WAS THE OCCURRENCE OF MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE) WITHIN 2 YEARS, INCLUDING CARDIOVASCULAR DEATH, SPONTANEOUS MYOCARDIAL INFARCTION, AND TARGET VESSEL REVASCULARIZATION. AMONG THE 128 ENROLLED PATIENTS, 22 (17.2%) EXPERIENCED MACE. POST IMRANGIO WAS SIGNIFICANTLY HIGHER IN PATIENTS WHO EXPERIENCED MACE THAN IN THOSE WHO DID NOT. INCREASED POST IMRANGIO WAS INDEPENDENTLY ASSOCIATED WITH MACE. RECEIVER OPERATING CHARACTERISTIC CURVE ANALYSIS IDENTIFIED OPTIMAL CUTOFF VALUES OF 40.6 FOR POST IMRANGIO TO PREDICT MACE. INCLUDING HIGH POST IMRANGIO (GREATER THAN 40U), ALONG WITH CLINICAL RISK FACTORS AND QFR FINDINGS, SIGNIFICANTLY IMPROVED THE DISCRIMINATORY AND RECLASSIFICATION ABILITY TO IDENTIFY THE RISK OF MACE AFTER RA. IMRANGIO MEASURED IMMEDIATELY AFTER THE PCI WITH RA FOLLOWED BY SECOND GENERATION DES IMPLANTATION IS A VALUABLE TOOL FOR RISK STRATIFICATION IN PATIENTS WITH SEVERELY CALCIFIED LESIONS. CLINICAL OUTCOME OF PATIENTS INCLUDED ALL CAUSE DEATH IN 12 CASES AND CARDIOVASCULAR DEATH IN 6 CASES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190164 ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown