BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM

    MDR report key: 17725760 · Received September 11, 2023

    Report

    Report Number
    2124215-2023-49064
    Event Type
    Injury
    Date Received
    September 11, 2023
    Date of Event
    August 30, 2023
    Report Date
    September 11, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1: PATIENT IDENTIFIER - (B)(4). A2: PATIENT AGE: 70 YEARS OLD AT TIME OF ENROLLMENT.

    Description of Event or Problem · 0

    ELEGANCE CLINICAL TRIAL IT WAS REPORTED THAT IN-STENT OCCLUSION OCCURRED. THE SUBJECT UNDERWENT TREATMENT WITH THE ELUVIA DRUG-ELUTING STENT ON 23-MAR-2023 AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE TARGET LESION WAS IN THE LEFT MID SUPERFICIAL FEMORAL ARTERY (SFA) WITH A 5.6 MM PROXIMAL REFERENCE VESSEL DIAMETER AND A 5 MM DISTAL REFERENCE VESSEL DIAMETER. THE LESION LENGTH WAS 31 MM WITH 100% STENOSIS AND WAS CLASSIFIED AS TASC II C LESION. PRIOR TO THE TARGET LESION TREATMENT WITH THE STUDY DEVICE, PRE-DILATION WAS PERFORMED USING A 5 MM X 120 MM NON-BOSTON SCIENTIFIC PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) SCORING BALLOON. TREATMENT OF THE TARGET LESION WAS PERFORMED BY PLACEMENT OF A 6 MM X 60 MM ELUVIA DRUG-ELUTING STENT STUDY DEVICE. FOLLOWING TREATMENT, POST-DILATION WAS PERFORMED BY USING A 5 MM X 40 MM NON-BOSTON SCIENTIFIC PTA BALLOON. FOLLOWING TREATMENT, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 5%. ON (B)(6) 2023, THE SUBJECT WAS DISCHARGED FROM HOSPITAL ON ASPIRIN. ON (B)(6) 2023, 160 DAYS POST INDEX PROCEDURE, THE SUBJECT WAS NOTED WITH SYMPTOMS RELATED TO SHALLOW FEMORAL OCCLUSION OF THE LEFT LOWER LIMB. IN RESPONSE TO THE EVENT, MEDICATION WAS GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1878962 ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING NIU BOSTON SCIENTIFIC CORPORATION 24653 0028791687

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other