BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM

    MDR report key: 13929779 · Received March 28, 2022

    Report

    Report Number
    2134265-2022-03455
    Event Type
    Injury
    Date Received
    March 28, 2022
    Date of Event
    February 25, 2022
    Report Date
    March 28, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AGE AT TIME OF EVENT: (B)(6) AT THE TIME OF STUDY ENROLLMENT. INITIAL REPORTER FACILITY NAME: (B)(6).

    Description of Event or Problem · 0

    (B)(6) CLINICAL STUDY. IT WAS REPORTED THAT IN-STENT RESTENOSIS OCCURRED. THE SUBJECT WAS ENROLLED IN THE EMINENT STUDY ON (B)(6) 2019, AND THE INDEX PROCEDURE WAS PERFORMED ON THE SAME DAY. TARGET LESION WAS LOCATED IN LEFT MID TO DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) WITH 90% STENOSIS. THE TARGET LESION WAS 150 MM LONG WITH A PROXIMAL REFERENCE VESSEL DIAMETER OF 5 MM AND A DISTAL REFERENCE VESSEL DIAMETER OF 6 MM. IT WAS CLASSIFIED AS A TASC II B LESION. TARGET LESION WAS TREATED WITH PRE-DILATATION FOLLOWED BY PLACEMENT OF TWO STUDY STENTS: 6 MM X 100 MM AND A 6 MM X 60 MM. FOLLOWING POST DILATION, RESIDUAL STENOSIS WAS 0%. ON (B)(6) 2019, THE SUBJECT WAS DISCHARGED WITH ANTIPLATELET THERAPY. ON (B)(6) 2022, 917 DAYS POST INDEX PROCEDURE, THE SUBJECT WAS DIAGNOSED WITH MIDDLE GRADED IN-STENT RE-STENOSIS OF SFA IN THE LEFT LEG. NO ACTION WAS TAKEN TO TREAT THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    879830 ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING NIU BOSTON SCIENTIFIC CORPORATION 24653 0023259439

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other