BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JETSTREAM ATHERECTOMY CATHETER

    MDR report key: 20347085 · Received October 1, 2024

    Report

    Report Number
    2124215-2024-57388
    Event Type
    Injury
    Date Received
    October 1, 2024
    Date of Event
    April 1, 2024
    Report Date
    October 1, 2024
    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

    B3: DATE OF EVENT IS ESTIMATED BASED ON THE DATE THE ARTICLE WAS PUBLISHED. TANEVA, G. T., PITOULIAS, A. G., AVRANAS, K., KAZEMTASH, M., ABU BAKR, N., DAHI, F., & DONAS, K. P. (2024). MIDTERM OUTCOMES OF ROTATIONAL ATHERECTOMY-ASSISTED ENDOVASCULAR TREATMENT OF SEVERE PERIPHERAL ARTERIAL DISEASE. JOURNAL OF VASCULAR SURGERY, 79(4), 887-892. HTTPS://DOI.ORG/10.1016/J.JVS.2023.12.030. AVRANAS, K.; PITOULIAS, A.G.; TANEVA, G.T.; BEROPOULIS, E.; DONAS, K.P. SEX-SPECIFIC ANALYSIS OF MID-TERM OUTCOMES OF ATHERECTOMY-ASSISTED ENDOVASCULAR TREATMENT IN SEVERE PERIPHERAL ARTERIAL DISEASE. J. CLIN. MED. 2024, 13, 3235. HTTPS://DOI.ORG/10.3390/JCM13113235.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA TWO LITERATURE ARTICLES WITH THE SAME DATA SET THAT THE USE OF JETSTREAM LED TO PATIENT COMPLICATIONS. TWO RETROSPECTIVE ANALYSES WERE CONDUCTED AT A SINGLE CENTER IN GERMANY, WHERE SUPERFICIAL FEMORAL (SFA) AND/OR POPLITEAL ARTERIES WERE TREATED WITH ATHERECTOMY-ASSISTED ANGIOPLASTY (JETSTREAM ROTATIONAL ATHERECTOMY AND DRUG-ELUTING BALLOONING). TECHNICAL SUCCESS WAS MET IN 96.1% OF CASES AT A MEDIAN OPERATIVE TIME OF 108 MINUTES. TEN PATIENTS (9.8%) PRESENTED FLOW-LIMITING DISSECTION AND/OR VESSEL RECOIL AFTER ATHERECTOMY AND DRUG-ELUTING BALLOON (DEB), REQUIRING ADJUNCTIVE STENTING IMPLANTATION. TWO PATIENTS EXPERIENCED SIGNIFICANT TIBIAL EMBOLIZATION (1.9%) WHICH WAS MANAGED SUCCESSFULLY USING A 4F CATHETER TO ASPIRATE THE DEBRIS THROUGH THE PREEXISTING 7F SHEATH. AT A MEDIAN FOLLOW-UP OF 18 MONTHS, RUTHERFORD CLASS CLINICAL IMPROVEMENT WAS PRESENT IN 77 PATIENTS (74.8%), AND 7 PATIENTS (6.79%) PRESENTED TARGET LESION OCCLUSION NEEDING REINTERVENTION IN 6 CASES (5.82%). DEB ANGIOPLASTY WAS USED IN THREE CASES, AND DEB FOLLOWED BY ADDITIONAL STENT IMPLANTATION WAS NEEDED IN 2 CASES DUE TO RESIDUAL STENOSIS. THE PERFORMANCE OF A FEMOROPOPLITEAL AND BELOW-THE-KNEE REVERSED VEIN BYPASS SURGERY WAS NEEDED IN ONE CASE (0.97%) OWING TO EXTENSIVE OCCLUSION CAUSED BY HEPARIN-INDUCED THROMBOCYTOPENIA. ONE PATIENT (0.97%) PRESENTED WITH LIFESTYLE-LIMITING CLAUDICATION TREATED CONSERVATIVELY DURING THE FOLLOW-UP. ONE CASE REQUIRED REINTERVENTION BY ENDOVASCULAR MEANS TO MAINTAIN PRIMARY TARGET LESION PATENCY. ACCESS SITE COMPLICATIONS OCCURRED IN SIX PATIENTS (5.8%) AS A HEMATOMA OR WOUND INFECTION. OCCLUSION OF THE CONTRALATERAL FEMORAL ARTERY THROUGH THE PERCUTANEOUS CLOSURE DEVICE WAS OBSERVED AFTER ONE PROCEDURE, MANAGED BY SURGICAL THROMBECTOMY. THE PRIMARY PATENCY RATES WERE 97% AT 12 MONTHS AND 83% AT 24 MONTHS WITH SECONDARY PATENCY RATES OF 99% AT 12 MONTHS AND 91% AT 24 MONTHS OF FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1916257 JETSTREAM ATHERECTOMY CATHETER CATHETER, PERIPHERAL, ATHERECTOMY MCW BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention