BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM

    MDR report key: 10115379 · Received June 3, 2020

    Report

    Report Number
    2134265-2020-07406
    Event Type
    Injury
    Date Received
    June 3, 2020
    Date of Event
    March 23, 2020
    Report Date
    June 3, 2020
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIU
    PMA / PMN Number
    P180011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    (B)(6) STUDY IT WAS REPORTED THAT IN-STENT RESTENOSIS AND STENT THROMBOSIS OCCURRED. THE SUBJECT WAS ENROLLED IN THE (B)(6) STUDY ON (B)(6) 2018 AND THE INDEX PROCEDURE WAS PERFORMED ON THE SAME DAY. THE TARGET LESION WAS LOCATED IN THE RIGHT MID TO DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) INVOLVING THE PROXIMAL POPLITEAL ARTERY. THE STENOSIS WAS 100% AND THE TARGET LESION WAS 100 MM LONG WITH A PROXIMAL REFERENCE VESSEL DIAMETER OF 6 MM AND DISTAL REFERENCE VESSEL DIAMETER OF 6 MM AND WAS CLASSIFIED AS TASC II B LESION. THE TARGET LESION WAS PRE-DILATED, AND TWO STUDY STENTS 6 MM X 120MM AND 6MM X 40MM WERE IMPLANTED TO TREAT THE LESION. FOLLOWING POST DILATION, RESIDUAL STENOSIS WAS 5%. ON (B)(6) 2018, THE SUBJECT WAS DISCHARGED WITH ANTIPLATELET THERAPY. ON (B)(6) 2020, 753 DAYS POST INDEX PROCEDURE, THE SUBJECT DEVELOPED STENOSIS IN THE RIGHT SFA. ON THE SAME DAY, THE SUBJECT WAS HOSPITALIZED FOR FURTHER EVALUATION AND TREATMENT. ANGIOGRAPHY WAS PERFORMED AS A DIAGNOSTIC MEASURE AND WHICH REVEALED PRESENCE OF STENOSIS AND THROMBUS IN THE TARGET LESION. ON (B)(6) 2020, 753 DAYS POST INDEX PROCEDURE, 100% STENOSIS WITH 400 MM LESION LENGTH AND REFERENCE VESSEL DIAMETER OF 6 MM WAS TREATED WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY, PLACEMENT OF A STENT, ATHERECTOMY AND DRUG COATED BALLOON DILATION WAS ALSO PERFORMED. POST TREATMENT REVEALED RESIDUAL STENOSIS OF 25%. ON (B)(6) 2020, THE EVENT WAS CONSIDERED TO BE RECOVERED/RESOLVED. ON (B)(6) 2020, THE SUBJECT WAS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579811 ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING NIU BOSTON SCIENTIFIC CORPORATION 24653 0019873609

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention