BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JETSTREAM ATHERECTOMY CATHETER

    MDR report key: 22543454 · Received July 18, 2025

    Report

    Report Number
    2124215-2025-43139
    Event Type
    Injury
    Date Received
    July 18, 2025
    Date of Event
    March 13, 2025
    Report Date
    July 17, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MCW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A2: MEAN AGE WAS 72 YEARS OLD. B3: DATE OF EVENT WAS NOT PROVIDED; THEREFORE, DATE OF ARTICLE PUBLICATION WAS USED. KOROSOGLOU, G., LEE, J. T., ANDRASSY, M., KOTELIS, D., USAI, M. V., DORIA, M., COSCAS, R., TROISI, N., NASR, B., SARATZIS, A., ANTONIADES, S., & DONAS, K. P. (2025). ATHERECTOMY-ASSISTED ENDOVASCULAR THERAPY VERSUS OPEN REPAIR FOR ATHEROSCLEROTIC COMMON FEMORAL ARTERY DISEASE: THE MULTICENTER ARISTON STUDY. VASCULAR MEDICINE, 30(2), 170-182. HTTPS://DOI.ORG/10.1177/1358863X251323508.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LITERATURE THAT PERFORATION, PSEUDOANEURYSM AND EMBOLISM OCCURRED, REQUIRING INTERVENTION. THE ARISTON STUDY WAS A MULTICENTER, RETROSPECTIVE RESEARCH COLLABORATIVE. DATA FOR CONSECUTIVE PATIENTS WHO PRESENTED WITH SYMPTOMATIC PERIPHERAL ARTERY DISEASE (PAD) DUE TO COMMON FEMORAL ARTERY (CFA) HIGH-GRADE STENOSIS OR OCCLUSION BETWEEN JANUARY 2015 AND JULY 2022 WERE COLLECTED. THE PATIENTS WERE TREATED WITH EITHER OPEN OR ENDOVASCULAR THERAPY DURING THE STUDY PERIOD. THIS STUDY WAS PERFORMED TO COMPARE THE RESULTS OF OPEN THERAPY VERSUS ENDOVASCULAR THERAPY, WHERE CFA LESION WAS GENERALLY TREATED WITH DIRECTIONAL, ROTATIONAL, OR HYBRID ATHERECTOMY FOLLOWED BY DRUG-COATED BALLOON (DCB) ANGIOPLASTY AND/OR BAILOUT NITINOL STENT PLACEMENT. OTHER LESION PREPARATION TECHNIQUES SUCH AS LITHOTRIPSY OR SPECIALTY BALLOONS WERE ALLOWED. SAFETY ENDPOINTS WERE PERFORATION, EMBOLIZATION REQUIRING REINTERVENTION OF SURGERY, ACCESS SITE COMPLICATIONS REQUIRING FURTHER INTERVENTIONS OR OPEN REPAIR WITH ENDOVASCULAR THERAPY AND REOPERATIONS, LYMPHOCELE, WOUNDS REQUIRING VACUUM-ASSISTED CLOSURE THERAPY, AND PERSISTENT NERVE IRRITATION WITH OPEN THERAPY. PRIMARY ENDPOINTS OF THE STUDY WERE ALL-CAUSE MORTALITY AND FREEDOM FROM CLINICALLY DRIVEN TARGET LESION REVASCULARIZATION (CD-TLR). SECONDARY ENDPOINTS WERE MAJOR (ABOVE THE ANKLE) AMPUTATION-FREE SURVIVAL (AFS) AND CLINICAL IMPROVEMENT OF AT LEAST ONE RUTHERFORD CATEGORY (RC) DURING FOLLOW UP. A TOTAL OF 826 PATIENTS WERE ANALYZED, INCLUDING 213 WHO UNDERWENT ENDOVASCULAR THERAPY. ATHERECTOMY WAS USED IN 177 ENDOVASCULAR THERAPY PATIENTS (35 TOTAL PATIENTS RECEIVED ROTATIONAL ATHERECTOMY USING THE 2.4/3.4 MM JETSTREAM ATHERECTOMY CATHETER) AND COMBINED WITH DCB WAS USED IN 173 PATIENTS. STENT PLACEMENT IN THE CFA WAS PERFORMED IN 22 ENDOVASCULAR THERAPY PATIENTS. WITH ENDOVASCULAR THERAPY, ONE PERFORATION OCCURRED DURING ATHERECTOMY, 11 EMBOLIZATIONS WERE SUCCESSFULLY TREATED WITHIN THE INDEX ENDOVASCULAR PROCEDURE, TWO EMBOLIZATIONS REQUIRED REINTERVENTIONS, AND TWO PSEUDOANEURYSMS WERE SUCCESSFULLY TREATED BY MANUAL COMPRESSION. WITH ATHERECTOMY, DISTAL EMBOLIC PROTECTION WAS USED IN 14 OUT OF 41 PATIENTS UNDERGOING DIRECTIONAL ATHERECTOMY WITH A NON- BOSTON SCIENTIFIC (BSC) DEVICE, IN 6 OF THE 35 PATIENTS UNDERGOING ROTATIONAL ATHERECTOMY WITH THE JETSTREAM DEVICE, AND IN NO PATIENTS UNDERGOING ROTATIONAL ATHERECTOMY WITH A NON-BSC DEVICE. DURING A MEDIAN DURATION OF TWO YEARS FOLLOW-UP, 84 PATIENTS HAD DIED, 17 UNDERWENT MAJOR ABOVE-THE-ANKLE AMPUTATION AND 86 UNDERWENT CD-TLR. DEATH WAS RELATED TO CARDIOVASCULAR CAUSES, SEPSIS, CANCER, AND TO UNKNOWN CAUSES (BECAUSE OF THE TIMING OF THE FOLLOW-UPS, IT WAS DETERMINED THAT THE DEATHS IN THIS STUDY WERE NOT RELATED TO THE JETSTREAM ATHERECTOMY DEVICES OR THE ATHERECTOMY PROCEDURES). ADDITIONALLY DURING FOLLOW-UP, RC IMPROVEMENT WAS NOTED IN 173 PATIENTS (90.6%) WHO UNDERWENT ENDOVASCULAR THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405857 JETSTREAM ATHERECTOMY CATHETER CATHETER, PERIPHERAL, ATHERECTOMY MCW BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Unknown Required Intervention