BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM

    MDR report key: 11689570 · Received April 19, 2021

    Report

    Report Number
    2134265-2021-04932
    Event Type
    Injury
    Date Received
    April 19, 2021
    Date of Event
    June 9, 2020
    Report Date
    May 13, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    E1 - INITIAL REPORTER FACILITY NAME: (B)(6). E1 - INITIAL REPORTER ADDRESS 1: (B)(6).

    Description of Event or Problem · 0

    EMINENT CLINICAL STUDY. IT WAS REPORTED THAT IN-STENT RESTENOSIS AND THROMBOSIS OCCURRED. THE SUBJECT WAS ENROLLED IN THE EMINENT STUDY ON (B)(6) 2018 AND THE INDEX PROCEDURE WAS PERFORMED ON THE SAME DAY. THE TARGET LESION WAS LOCATED IN RIGHT MID SUPERFICIAL FEMORAL ARTERY (SFA) WITH 100% STENOSIS AND WAS 45 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 A LESION. THE TARGET LESION WAS TREATED WITH PRE-DILATATION FOLLOWED BY PLACEMENT OF 7 MM X 60 MM STUDY STENT. FOLLOWING POST DILATION, RESIDUAL STENOSIS WAS 0%. ON (B)(6) 2018, THE SUBJECT WAS DISCHARGED ON ANTIPLATELET THERAPY. ON (B)(6) 2020, 820 DAYS POST INDEX PROCEDURE, THE SUBJECT DEVELOPED IN-STENT OCCLUSION RIGHT PROXIMAL/ MID / DISTAL SFA. THE SUBJECT WAS RECOMMENDED TO UNDERGO INTERVENTIONAL PROCEDURE AS A TREATMENT FOR THIS EVENT ON A LATER DATE. ON (B)(6) 2020, 828 DAYS POST INDEX PROCEDURE, THE SUBJECT WAS HOSPITALIZED FOR THE PLANNED INTERVENTIONAL TREATMENT. ON (B)(6) 2020, BY USING THE LYSIS CATHETER THE THROMBOLYSIS WAS PERFORMED FOLLOWED BY PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY, STENT PLACEMENT WAS PERFORMED TO TREAT THE EVENT. ON (B)(6) 2020, THE EVENT WAS CONSIDERED RECOVERED/ RESOLVED. IT WAS FURTHER REPORTED THAT ON (B)(6) 2020 THE SUBJECT EXPERIENCED SUDDEN ONSET OF MASSIVE PAIN IN THE REGION OF THE RIGHT LOWER LEG, AFTER WALKING FOR ABOUT A DISTANCE OF 5 TO 10 METERS. ON (B)(6) 2020 THE SUBJECT WAS HOSPITALIZED FOR THE FURTHER TREATMENT AND EVALUATION. ON EXAMINATION, RIGHT FOOT WAS CLINICALLY COOLER AND ONLY INGUINAL PULSE WAS NOTED TO BE PALPABLE AND PERIPHERAL ARTERIAL OCCLUSIVE DISEASE (PAOD) WAS STAGE IIB ON THE RIGHT. ON RADIOLOGY EXAMINATION, ACUTE ON CHRONIC OCCLUSION WAS NOTED IN THE ALREADY STENTED MIDDLE AND DISTAL SFA SEGMENTS ON THE RIGHT LIMB. ON (B)(6) 2020, 100% STENOSIS AND 190 MM LESION LENGTH WITH 5.5 MM REFERENCE VESSEL DIAMETER WAS TREATED USING RECANALIZATION FOLLOWED BY 4F LYSIS CATHETER WITH A LYSIS STRETCH OF 20CM WAS USED AND THROMBOLYSIS WAS PERFORMED WITH 4MG OF ACTILYSE FOR 6 HOURS VIA LYSIS THERAPY AND LYSIS THERAPY WAS CONTINUED TILL (B)(6) 2020. POST TREATMENT, FINAL RESIDUAL STENOSIS WAS 20%. OF NOTE, PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY, STENT PLACEMENT AND THROMBOLYSIS WERE PERFORMED TO TREAT THE EVENT HOWEVER, PER SOURCE ONLY THROMBOLYSIS WAS PERFORMED. ON (B)(6) 2020, THE EVENT WAS CONSIDERED RECOVERED/ RESOLVED AND THE SUBJECT WAS DISCHARGED.

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    (B)(6) STUDY. IT WAS REPORTED THAT IN-STENT RESTENOSIS AND 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 RIGHT MID SUPERFICIAL FEMORAL ARTERY (SFA) WITH 100% STENOSIS AND WAS 45 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 A LESION. THE TARGET LESION WAS TREATED WITH PRE-DILATATION FOLLOWED BY PLACEMENT OF 7 MM X 60 MM STUDY STENT. FOLLOWING POST DILATION, RESIDUAL STENOSIS WAS 0%. ON (B)(6) 2018, THE SUBJECT WAS DISCHARGED ON ANTIPLATELET THERAPY. ON (B)(6) 2020, 820 DAYS POST INDEX PROCEDURE, THE SUBJECT DEVELOPED IN-STENT OCCLUSION RIGHT PROXIMAL/ MID / DISTAL SFA. THE SUBJECT WAS RECOMMENDED TO UNDERGO INTERVENTIONAL PROCEDURE AS A TREATMENT FOR THIS EVENT ON A LATER DATE. ON (B)(6) 2020, 828 DAYS POST INDEX PROCEDURE, THE SUBJECT WAS HOSPITALIZED FOR THE PLANNED INTERVENTIONAL TREATMENT. ON (B)(6) 2020, 829 DAYS POST-INDEX PROCEDURE, BY USING THE LYSIS CATHETER THE THROMBOLYSIS WAS PERFORMED FOLLOWED BY PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY, STENT PLACEMENT WAS PERFORMED TO TREAT THE EVENT. ON (B)(6) 2020, THE EVENT WAS CONSIDERED RECOVERED/ RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582839 ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING NIU BOSTON SCIENTIFIC CORPORATION 24653 0019375764

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R