BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM

    MDR report key: 12481288 · Received September 16, 2021

    Report

    Report Number
    2134265-2021-11623
    Event Type
    Injury
    Date Received
    September 16, 2021
    Date of Event
    August 13, 2021
    Report Date
    September 16, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    CLINICAL TRIAL (B)(6). IT WAS REPORTED THAT IN-STENT THROMBOSIS OCCURRED. THE SUBJECT WAS ENROLLED IN THE (B)(6) CLINICAL STUDY ON (B)(6) 2018 AND THE INDEX PROCEDURE WAS PERFORMED ON THE SAME DAY. THE TARGET LESION WAS 70% STENOSIS LOCATED IN THE RIGHT DISTAL SUPERFICIAL FEMORAL ARTERY (SFA), 60 MM LONG WITH A PROXIMAL REFERENCE VESSEL DIAMETER OF 8 MM AND DISTAL REFERENCE VESSEL DIAMETER OF 6 MM AND WAS CLASSIFIED AS A TASC II A LESION. THE TARGET LESION WAS TREATED WITH DIRECT PLACEMENT OF A 6 MM X 60 MM ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM. FOLLOWING POST-DILATION, RESIDUAL STENOSIS WAS 18%. THE SUBJECT WAS DISCHARGED WITH ANTIPLATELET THERAPY THE NEXT DAY. ON (B)(6) 2021, 980 DAYS POST-INDEX PROCEDURE, THE SUBJECT PRESENTED DUE TO RECENTLY WORSENING LOWER LIMB PAIN WITHOUT TROPHIC DISORDER AND A COMPLETE THROMBOSIS NOTED IN THE RIGHT SFA STENT. DOPPLER ULTRASOUND EXAMINATION OF THE LOWER EXTREMITY ARTERIAL SYSTEM REVEALED THE STENT COMPLETELY THROMBOSED WITH A RESUMPTION OF PATENCY IN THE REGION OF THE PROXIMAL POPLITEAL ARTERY WITH SUBSEQUENT DEMODULATED AND DAMPENED FLOW IN THE THREE ARTERIES OF THE LEG, WHICH WERE STILL PERFECTLY PATENT. THE COMMON FEMORAL ARTERY WAS NICELY PATENT, HOWEVER, A LARGE POSTERIOR CALCIFIED PLAQUE, WITHOUT ANYTHING TO SUGGEST SIGNIFICANT STENOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1380858 ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING NIU BOSTON SCIENTIFIC CORPORATION 24653 0021887981

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other