BEUDAMED
    FDA Adverse Event Death Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 25045436 · Received April 30, 2026

    Report

    Report Number
    2124215-2026-23444
    Event Type
    Death
    Date Received
    April 30, 2026
    Date of Event
    February 1, 2018
    Report Date
    April 30, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MCX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3 DATE OF EVENT: EARLIEST POSSIBLE DATE OF EVENT AS THE PATIENT UNDERWENT PCI FEBRUARY 2018 TO MARCH 2023. CITATION: KANABAR, KEWAL ET AL. SHORT-TERM OUTCOMES OF ROTATIONAL ATHERECTOMY IN PATIENTS WITH REDUCED LEFT VENTRICULAR EJECTION FRACTION: A RETROSPECTIVE REVIEW FROM A TERTIARY REFERRAL CENTRE. INDIAN HEART JOURNAL VOL. 77,3 (2025): 170-173. DOI:10.1016/J.IHJ.2025.03.017. INITIAL REPORTER ADDRESS: O BLOCK, 1ST FLOOR, OFFICE OF THE MEDICAL SUPERINTENDENT, WCSH BUILDING, CIVIL HOSPITAL, ASARWA. DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER SPECIFIC PRODUCT INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LITERATURE THAT PATIENT DEATH OCCURRED. THIS IS A RETROSPECTIVE, SINGLE-CENTRE REVIEW OF ALL CONSECUTIVE PATIENTS WHO UNDERWENT PERCUTANEOUS CORONARY INTERVENTION (PCI) WITH ROTATIONAL ATHERECTOMY (RA) AT A TERTIARY CARE CENTRE BETWEEN FEBRUARY 2018 TO MARCH 2023. PCI WITH RA WAS DONE FOR SEVERELY CALCIFIC LESIONS AS A PRIMARY APPROACH OR AS A BAILOUT TECHNIQUE FOR BALLOON UNCROSSABLE OR NON- DILATABLE LESIONS BY TRAINED SENIOR INTERVENTIONAL CARDIOLOGISTS WHO WERE ALL WELL VERSED WITH THIS TECHNIQUE. SEVERE CALCIFICATION WAS DEFINED AS FLUOROSCOPIC APPRECIABLE RADIO-OPACITIES WITHIN THE VESSEL WALL WITHOUT CARDIAC MOTION BEFORE CONTRAST ADMINISTRATION AND AFFECTING BOTH SIDES OF VESSEL WALL. ALL RAS WERE PERFORMED USING THE ROTABLATOR SYSTEM. HE BURR WAS SIZED AIMING AT A BURR/VESSEL RATIO OF 0.5 (MAXIMUM) AND ROTATIONAL SPEED WAS SET AT 160,000 TO 180,000 ROTATIONS PER MINUTE (RPM). A CONTINUOUS INFUSION OF UNFRACTIONATED HEPARIN (UFH), NITRO GLYCERINE, AND VERAPAMIL WAS USED DURING RA AS PER THE ESTABLISHED TECHNIQUE.15,17PRE-PROCEDURE ANTIPLATELET AND PROCEDURAL ANTI COAGULATION WAS ADMINISTERED AS PER THE ESTABLISHED GUIDELINES FOR PCI. ROTABLATION WAS DONE AS PER THE ESTABLISHED TECHNIQUE, INCLUDING A POLISHING RUN IN ALL CASES. THE USE OF AN INTRA-AORTIC BALLOON PUMP (UPFRONT OR BAILOUT), TEMPORARY PACING, AND INTRA-CORONARY IMAGING WAS AS PER OPERATORS DISCRETION. TWO-DIMENSIONAL ECHOCARDIOGRAPH WAS DONE TO ASSESS THE LVEF USING THE BIPLANE SIMPSON METHOD. THE PRIMARY ENDPOINT ASSESSED WAS IN-HOSPITAL MORTALITY. PROCEDURAL SUCCESS WAS DEFINED AS SUCCESSFUL REVASCULARIZATION WITH <30 % RESIDUAL DIAMETER STENOSIS (ANGIOGRAPHIC) WITHIN THE TREATED SEGMENT AND TIMI GRADE III ANTEGRADE FLOW IN ABSENCE OF IN-HOSPITAL DEATH, CORONARY DISSECTION AND PERFORATION. A TOTAL OF 504 PATIENTS UNDERWENT RA-ASSISTED PCI OVER THE STUDY DURATION. THE PATIENTS UNDERGOING RA WERE PREDOMINANTLY ELDERLY MALES AND MAJORITY WERE HYPERTENSIVE (53.7 %) AND/OR DIABETIC (49.2 %). THE MEAN LV EJECTION FRACTION WAS 42 %PLUS OR MINUS11.7 %. TRANS-RADIAL PCI WAS DONE IN 48 % OF CASES AND INTRA-VASCULAR IMAGING WAS USED IN 7 %. THE MOST COMMON TARGET VESSEL WAS LAD (60 %), FOLLOWED BY RCA (23 %) AND LMCA (10 %). THE IN-HOSPITAL MORTALITY WAS 1.4 %. THE PATIENTS WERE DIVIDED INTO TWO GROUPS: GROUP 1 (MEAN LVEF 29.14 PLUS OR MINUS 4.95 %) WITH SEVERELY REDUCED LVEF AS DESCRIBED IN PRIOR STUDIES (LVEF LESS THAN OR EQUAL TO 35 %) AND GROUP 2 (MEAN LVEF 47.86PLUS OR MINUS 6.68 %) WITH MODERATELY REDUCED OR PRESERVED LVEF (>35 %). ONE PATIENT WITH LVEF OF 20% WHO UNDERWENT DOUBLE-VESSEL ROTABLATION OF LMCA, LAD AND LCX DIED ON TABLE SECONDARY TO SLOW FLOW AND CORONARY SPASM. ONE PATIENT IN GROUP 1 DIED SECONDARY TO PERFORATION AND CARDIAC TAMPONADE. TWO PATIENTS WITH LVEF 20 % (GROUP 1) AND ONE IN GROUP 2 (LVEF 40 %) DIED OF POST-PROCEDURE REFRACTORY HEART FAILURE. ONE PATIENT WITH LVEF 20 % DIED SECONDARY TO SEVERE COVID-19. ONE PATIENT WITH LVEF 45 % DIED SECONDARY TO REFRACTORY VENTRICULAR TACHYCARDIA. OTHER COMPLICATIONS INCLUDED PERFORATION IN 3 PATIENTS, SLOW FLOW IN 17 PATIENTS, FLOW-LIMITING DISSEDCTION IN 4 PATIENTS AND THE NEED FOR CABG WITH 1 PATIENT. IN A LARGE RETROSPECTIVE REVIEW OF ALL CONSECUTIVE PATIENTS WHO UNDERWENT PCI WITH RA AT A LARGE TERTIARY REFERRAL CENTRE, WE DID NOT FIND A SIGNIFICANT DIFFERENCE IN IN-HOSPITAL MORTALITY BETWEEN PATIENTS WITH SEVERE LV DYSFUNCTION VERSUS THOSE WITH MODERATE DYSFUNCTION OR NORMAL LV FUNCTION. THE IN-HOSPITAL MORTALITY IN THE ENTIRE STUDY GROUP (1.4 %) IS SIMILAR TO THE EXISTING LITERATURE ON THE OUTCOMES OF RA. ALSO, THE INCIDENCE OF CORONARY SLOW-FLOW AFTER RA RESULTING IN Q-WAVE/NON-Q-WAVE INFARCTION ARE SIMILAR TO THE ALREADY PUBLISHED LITERATURE. THE RESULTS OF THE CURRENT STUDY REGARDING THE OUTCOMES IN PATIENTS WITH SEVERE LV DYSFUNCTION ARE CONTRARY TO MOST OF THE REPORTS WHICH DEMONSTRATE THE INCREASE IN MAJOR ADVERSE CARDIAC EVENTS IN THESE HIGH- RISK PATIENTS UNDERGOING PCI WITH RA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190017 ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1