BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM

    MDR report key: 17087742 · Received June 8, 2023

    Report

    Report Number
    2124215-2023-29404
    Event Type
    Injury
    Date Received
    June 8, 2023
    Date of Event
    May 17, 2023
    Report Date
    June 8, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIU
    UDI-DI
    08714729876601
    PMA / PMN Number
    P180011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ELUVIA RESTENOSIS PROGRAM: IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVASCULARIZATION PROCEDURE 272 DAYS FOLLOWING THE INDEX PROCEDURE. ON (B)(6) 2022, THE PATIENT UNDERWENT AN ATHERECTOMY PROCEDURE TO TREAT ATHEROSCLEROTIC PERIPHERAL VASCULAR DISEASE WITH CLAUDICATION. THE TARGET LESION WAS LOCATED WITHIN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA) AND P1 POPLITEAL ARTERY. RETROGRADE ACCESS WAS OBTAINED TO THE RIGHT COMMON FEMORAL ARTERY. USING IMAGING GUIDANCE, A CATHETER AND GUIDEWIRE WERE POSITIONED ACROSS THE AREA OF STENOSIS. A NON-BSC FILTER WIRE WAS POSITIONED IN THE P3 POPLITEAL ARTERY. MECHANICAL ATHERECTOMY IN THE LEFT SFA AND POPLITEAL ARTERY WAS THEN PERFORMED USING A JETSTREAM CATHETER. PERCUTANEOUS TRANSLUMINAL BALLOON ANGIOPLASTY WAS THEN PERFORMED USING AN UNKNOWN BALLOON ALONG THE LENGTH OF THE SFA AND P1 POPLITEAL ARTERY. FOLLOW-UP IMAGING DEMONSTRATED SUBOPTIMAL RESULTS. BALLOON ANGIOPLASTY WAS REPEATED, BUT NO SIGNIFICANT CHANGE WAS NOTED. TRANSCATHETER STENTING WAS THEN PERFORMED AT THE P1 POPLITEAL ARTERY WITH AN ELUVIA DRUG-ELUTING VASCULAR STENT. THE STENT WAS POST DILATED USING AN UNKNOWN 6X100 MM BALLOON. FOLLOW-UP IMAGING DEMONSTRATED EXCELLENT RESULTS. THE NON-BSC FILTER WIRE WAS RETRIEVED, AND COMPLETION ARTERIOGRAM SHOWS NO EVIDENCE OF DISTAL EMBOLIZATION. THE PATIENT TOLERATED THE PROCEDURE WELL. ON (B)(6) 2023, 272 DAYS POST INDEX PROCEDURE, THE PATIENT UNDERWENT A REVASCULARIZATION PROCEDURE. THE TARGET LESION WAS LOCATED WITHIN THE LEFT SFA AND POPLITEAL ARTERY. RETROGRADE ACCESS WAS OBTAINED TO THE RIGHT COMMON FEMORAL ARTERY. USING IMAGE GUIDANCE, A CATHETER AND GUIDEWIRE WERE POSITIONED ACROSS THE AREA OF STENOSIS. A NON-BSC FILTER WIRE WAS POSITIONED IN THE P3 POPLITEAL ARTERY. MECHANICAL ATHERECTOMY IN THE LEFT SFA AND POPLITEAL ARTERY WAS THEN PERFORMED USING A JETSTREAM CATHETER. PERCUTANEOUS TRANSLUMINAL BALLOON ANGIOPLASTY WAS THEN PERFORMED USING AN UNKNOWN BALLOON ALONG THE LENGTH OF THE SFA AND POPLITEAL ARTERY. FOLLOW-UP IMAGING DEMONSTRATED SUBOPTIMAL RESULTS DUE TO MODERATE RESIDUAL STENOSIS. BALLOON ANGIOPLASTY WAS REPEATED USING A RANGER DRUG-COATED BALLOON, BUT MODERATE RESIDUAL STENOSIS REMAINED THE SAME IN THE MID SFA. TRANSCATHETER STENTING WAS THEN PERFORMED USING AN ELUVIA DRUG-ELUTING VASCULAR STENT. BALLOON ANGIOPLASTY WAS THEN PERFORMED USING AN UNKNOWN ANGIOPLASTY BALLOON. FOLLOW-UP IMAGING DEMONSTRATED EXCELLENT RESULTS. THE PATIENT TOLERATED THE PROCEDURE WELL. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1274891 ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING NIU BOSTON SCIENTIFIC CORPORATION 24657 0028043225 08714729876601

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Unknown Required Intervention