BEUDAMED
    FDA Adverse Event Death Summary report: N

    ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM

    MDR report key: 18907515 · Received March 14, 2024

    Report

    Report Number
    2124215-2024-15178
    Event Type
    Death
    Date Received
    March 14, 2024
    Date of Event
    December 1, 2023
    Report Date
    March 14, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1: PATIENT ID: (B)(6). A2: PATIENT AGE: 73 YEARS OLD AT TIME OF ENROLLMENT.

    Description of Event or Problem · 0

    ELEGANCE CLINICAL STUDY. IT WAS REPORTED THAT THE SUBJECT PASSED AWAY. ON (B)(6) 2023, THE SUBJECT UNDERWENT TREATMENT WITH ELUVIA DRUG ELUTING STENTS AS PART OF THE ELEGANCE CLINICAL TRIAL. THE TARGET LESION WAS LOCATED IN THE 100% STENOSED LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA) EXTENDING UP TO THE LEFT MID-SFA; WITH A 5 MM PROXIMAL REFERENCE VESSEL DIAMETER, AND A 5 MM DISTAL REFERENCE VESSEL DIAMETER, WITH A 240 MM LESION LENGTH. THE LESION WAS CLASSIFIED AS TRANSATLANTIC INTERSOCIETY CONSENSUS (TASC) II C LESION. PRIOR TO THE TREATMENT OF THE TARGET LESION WITH THE STUDY DEVICES, PRE-DILATION WAS PERFORMED USING 6 MM X 150 MM AND 5 MM X 120 MM PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON. TREATMENT OF THE TARGET LESION WAS THEN PERFORMED BY PLACEMENT OF TWO 6 MM X 120 MM DRUG ELUTING STENTS, AND ONE 6 MM X 40 MM ELUVIA DRUG ELUTING STENT. POST PROCEDURE, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 0%. ON (B)(6) 2023, THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL ON DUAL ANTI-PLATELET THERAPY. ON APPROXIMATELY (B)(6) 2023, THE SUBJECT PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1027434 ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING NIU BOSTON SCIENTIFIC CORPORATION 24653 0029637314

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Death ELUVIA DRUG ELUTING VASCULAR STENTS