BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM

    MDR report key: 13721845 · Received March 10, 2022

    Report

    Report Number
    2134265-2022-02701
    Event Type
    Injury
    Date Received
    March 10, 2022
    Date of Event
    February 11, 2022
    Report Date
    March 10, 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) YEARS OLD AT THE TIME OF STUDY ENROLLMENT. INITIAL REPORTER FACILITY NAME: (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT IN-STENT RESTENOSIS OCCURRED. THE SUBJECT WAS ENROLLED IN THE (B)(6) STUDY ON (B)(6) 2020 AND THE INDEX PROCEDURE WAS PERFORMED ON THE SAME DAY. TARGET LESION WAS LOCATED IN LEFT DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) INVOLVING PROXIMAL POPLITEAL ARTERY WITH 100% STENOSIS. THE TARGET LESION WAS 70 MM LONG WITH A PROXIMAL REFERENCE VESSEL DIAMETER OF 5.5 MM AND A DISTAL REFERENCE VESSEL DIAMETER OF 5 MM. IT WAS CLASSIFIED AS A TASC II B LESION. THE TARGET LESION WAS TREATED WITH PRE-DILATATION FOLLOWED BY PLACEMENT OF A 6 MM X 80 MM STUDY STENT. FOLLOWING POST DILATION, RESIDUAL STENOSIS WAS 10%. ON (B)(6) 2020, THE SUBJECT WAS DISCHARGED WITH ANTIPLATELET THERAPY. ON (B)(6) 2022, 730 DAYS POST INDEX PROCEDURE, THE SUBJECT PRESENTED FOR PROTOCOL SCHEDULED 24-MONTH FOLLOW UP VISIT WITH COMPLAINTS OF SLIGHT PROBLEMS IN WALKING AND WAS UNABLE TO WALK 1 BLOCK QUICKLY OR CLIMB 3 FLIGHTS OF STAIRS. ON ARRIVAL, ANKLE BRACHIAL INDEX (ABI) RATIO WAS 0.9. THE SUBJECT WAS DIAGNOSED WITH MIDDLE GRADED IN-STENT RESTENOSIS OF LEFT DISTAL SUPERFICIAL FEMORAL ARTERY (AT THE PROXIMAL EDGE OF THE STENT). NO ACTION WAS TAKEN TO TREAT THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1526477 ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING NIU BOSTON SCIENTIFIC CORPORATION 24653 0023795661

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other