BEUDAMED
    FDA Adverse Event Death Summary report: N

    ROTAPRO

    MDR report key: 23658605 · Received November 26, 2025

    Report

    Report Number
    2124215-2025-86891
    Event Type
    Death
    Date Received
    November 26, 2025
    Date of Event
    September 1, 2021
    Report Date
    November 26, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MCX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ROTATIONAL ATHERECTOMY WITH OR WITHOUT INTRAVASCULAR LITHOTRIPSY FOR PATIENTS WITH HEAVY CORONARY ARTERY CALCIFICATION, LEONE, PIER PASQUALE ET AL., AMERICAN JOURNAL OF CARDIOLOGY, VOLUME 255, 41 - 48. B2 DATE OF DEATH AND B3 DATE OF EVENT WERE ESTIMATED BASED ON THE FIRST DAY OF THE MONTH THE STUDY WAS STARTED, BASED ON IT BEING REPORTED THERE WERE IN-HOSPITAL DEATHS. 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 VIA LITERATURE THAT PATIENT DEATH OCCURRED. RECENT ADVANCES IN CALCIUM DEBULKING TECHNOLOGIES MAY CONTRIBUTE TO DEVELOPMENT OF NEW PERCUTANEOUS CORONARY INTERVENTION (PCI) PARADIGMS FOR PATIENTS WITH HEAVY CORONARY ARTERY CALCIFICATION (CAC). COMPARATIVE DATA ON SAFETY AND CLINICAL EFFICACY OF A COMBINATION STRATEGY INCLUDING ROTATIONAL ATHERECTOMY (RA) AND INTRAVASCULAR LITHOTRIPSY (IVL) IS LACKING. THE AIM OF THE STUDY WAS TO DETERMINE THE ADDITIONAL EFFECT OF IVL WHEN PERFORMED AFTER RA IN PATIENTS WITH HEAVY CAC. RA WAS PERFORMED WITH THE ROTAPRO SYSTEM. IVL WITH NON-BOSTON SCIENTIFIC (NON-BSC) LITHOPLASTY SYSTEM WAS PERFORMED AFTER RA IN THE IVL GROUP. THE USE OF MORE THAN 1 BALLOON WAS ALLOWED, SO THAT ADDITIONAL LESION PREPARATION WITH STANDARD OR SPECIALTY BALLOONS BEFORE OR AFTER EITHER USE OF RA OR IVL WAS LEFT TO THE DISCRETION OF THE OPERATOR. CURRENT GENERATION DRUG-ELUTING STENT IMPLANTATION FOLLOWED LESION PREPARATION, AND POST DILATION WAS PERFORMED AT OPERATOR DISCRETION. INTRAVASCULAR IMAGING ADOPTION FOLLOWED STANDARD PRACTICE; ALTHOUGH NOT MANDATORY, IT WAS STRONGLY RECOMMENDED. A TOTAL OF 6,845 PCIS WAS PERFORMED BETWEEN SEPTEMBER 1, 2021 AND AUGUST 31, 2023. AMONG THESE, 1,365 (20%) PATIENTS UNDERWENT PCI WITH RA: 150 (11%) WERE ADDITIONALLY TREATED WITH IVL, WHILE 1,215 (89%) WERE NOT. FEMORAL ACCESS WAS THE MOST COMMON IN BOTH RA + IVL AND RA GROUPS (87% VS 81%, P = 0.082). INTRAVASCULAR IMAGING WAS MORE COMMONLY PERFORMED IN THE RA + IVL GROUP (45% VS 22%, P < 0.001), AND THIS OBSERVATION WAS PARALLELED BY A HIGHER PROPORTION OF PATIENTS IN THE RA + IVL GROUP BEING TREATED FOR LESIONS IN THE LEFT MAIN (24% VS 16%, P = 0.018). THE SYNTAX (SYNERGY BETWEEN PCI WITH TAXUS AND CARDIAC SURGERY) SCORE WAS SLIGHTLY HIGHER AMONG RA + IVL PATIENTS (22 +/- 13 VS 20 +/- 13, P = 0.093). TOTAL LESION LENGTH WAS SIMILAR BETWEEN GROUPS (28 +/- 14 MM VS 30 +/- 13 MM, P = 0.151). THE PROPORTION OF PATIENTS WITH IN-STENT RESTENOSIS WAS HIGHER IN THE RA + IVL GROUP (26% VERSUS 17%, P = 0.01). CLINICAL OUTCOMES AT 30-DAY FOLLOW-UP ARE REPORTED. THE RISK FOR 30-DAY MACE WAS SIMILAR IN RA + IVL AND RA GROUPS (2.7% VS 2.6%, OR: 1.05; 95% CI: 0.31 TO 2.69), AND NO DIFFERENCE IN ITS SINGLE COMPONENTS WAS OBSERVED: DEATH (0% VS 1.2%), MI (0.7% VS 0.9%), STROKE (0% VS 0.1%) AND TVR (2.0% VS 0.7%). PROPENSITY SCORE-STRATIFIED OUTCOMES CONFIRMED A SIMILAR RISK FOR 30-DAY MACE BETWEEN GROUPS (OR: 0.89; 95% CI: 0.30 TO 2.64).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2620424 ROTAPRO CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death