BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM

    MDR report key: 11923481 · Received June 2, 2021

    Report

    Report Number
    2134265-2021-07149
    Event Type
    Injury
    Date Received
    June 2, 2021
    Date of Event
    March 22, 2021
    Report Date
    June 25, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIU
    PMA / PMN Number
    P180011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT IN-STENT RESTENOSIS OCCURRED. THE SUBJECT WAS ENROLLED IN THE EMINENT STUDY ON (B)(6) 2018 AND THE INDEX PROCEDURE WAS PERFORMED ON THE SAME DAY. TARGET LESION WAS LOCATED IN THE RIGHT MID SUPERFICIAL FEMORAL ARTERY (SFA) WITH 100% STENOSIS AND WAS 35 MM LONG WITH A PROXIMAL REFERENCE VESSEL DIAMETER OF 5 MM AND A DISTAL REFERENCE VESSEL DIAMETER OF 4.4 MM AND WAS CLASSIFIED AS TASC II A LESION. TARGET LESION WAS PRE-DILATED AND TREATED WITH PLACEMENT OF A 6 MM X 120 MM STUDY STENT. FOLLOWING POST DILATION, RESIDUAL STENOSIS WAS 0%. ON (B)(6) 2018, THE SUBJECT WAS DISCHARGED WITH ANTIPLATELET MEDICATION. ON (B)(6) 2021, 923 DAYS POST INDEX PROCEDURE, THE SUBJECT PRESENTED WITH UNKNOWN SYMPTOMS AND WAS DIAGNOSED WITH IN-STENT STENOSES. THE SUBJECT WAS RECOMMENDED TO UNDERGO SURGICAL INTERVENTION AS TREATMENT FOR THIS EVENT ON A LATER DATE. ON (B)(6) 2021, THE SUBJECT WAS HOSPITALIZED FOR PLANNED INTERVENTION. ON (B)(6) 2021, 91% STENOSIS IN THE TARGET LESION WITH REFERENCE VESSEL DIAMETER OF 5.5 MM AND 190 MM LESION LENGTH WAS TREATED WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY USING DRUG-COATED BALLOON. POST PROCEDURE, FINAL RESIDUAL STENOSIS WAS 5%. ON (B)(6) 2021, THE EVENT WAS CONSIDERED RECOVERED/RESOLVED AND THE SUBJECT WAS DISCHARGED ON THE SAME DAY. IT WAS FURTHER REPORTED THAT ON (B)(6) 2021, THE SUBJECT UNDERWENT ANKLE/ARM INDEX (AAI) WITH WALKING TEST AND TOE PRESSURE REPORT REVEALED SIGNIFICANT PLAQUE ON THE COMMON FEMORAL ARTERY. ON (B)(6) 2021, SUBJECT VISITED AS AN OUTPATIENT AND COMPLAINED OF LIMITED WALKING ON THE RIGHT SIDE AND WALKED ON TREADMILL RATHER THAN OUTSIDE. ON ARRIVAL, THE SUBJECT WAS ON PLAVIX (CLOPIDOGREL) AND STATINS. AAI PERFORMED ON THE SAME DAY REVEALED 0.61 TO 0.21 ON THE RIGHT AND 0.75 TO 0.43 ON THE LEFT AND STOPPED AFTER 500 METERS DUE TO MUCH PAIN EXPERIENCED IN THE RIGHT CALF. DUPLEX ULTRASOUND PERFORMED ON THE SAME DAY REVEALED INSTENT 3X STENOSIS CONCLUDING DEBILITATING FONTAINE STAGE II ON THE RIGHT. BASED ON THESE SYMPTOMS AND DIAGNOSTIC IMAGING, THE SUBJECT WAS DIAGNOSED WITH IN-STENT STENOSIS. AT THE TIME OF EVENT, THE SUBJECT WAS ON CLOPIDOGREL AND WAS RECOMMENDED TO CONTINUE THE SAME. ON (B)(6) 2021, TARGET LESION WAS TREATED WITH PRE-DILATATION USING A 5 MM BALLOON TO THE ENTIRE DISTAL SEGMENT OF THE SFA, FOLLOWED BY DILATATION USING A 6 MM DRUG-ELUTING BALLOON. LATER, PROXIMAL SEGMENT OF THE SFA WAS TREATED WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) USING A DRUG-COATED 5 MM BALLOON, WHICH WAS DILATED TWICE. THE SUBJECT WAS PRESCRIBED WITH DOUBLE PLATELET AGGREGATION INHIBITORS. FOLLOW UP ANGIOGRAPHY REVEALED GOOD OUTCOME WITH PATENT SFA AND WITH NO OTHER COMPLICATIONS NOTED IN SFA. ON (B)(6) 2021, THE SUBJECT RE-VISITED FOR A FOLLOW UP AS AN OUTPATIENT AND GOOD OUTCOME WITH NO OTHER SYMPTOMS IN THE RIGHT LEG WAS NOTED. HOWEVER, ASCAL WAS RECOMMENDED TO BE CONTINUED UNTIL (B)(6) 2021.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN-STENT RESTENOSIS OCCURRED. THE SUBJECT WAS ENROLLED IN THE (B)(6) STUDY ON (B)(6) 2018 AND THE INDEX PROCEDURE WAS PERFORMED ON THE SAME DAY. TARGET LESION WAS LOCATED IN THE RIGHT MID SUPERFICIAL FEMORAL ARTERY (SFA) WITH 100% STENOSIS AND WAS 35 MM LONG WITH A PROXIMAL REFERENCE VESSEL DIAMETER OF 5 MM AND A DISTAL REFERENCE VESSEL DIAMETER OF 4.4 MM AND WAS CLASSIFIED AS TASC II A LESION. TARGET LESION WAS PRE-DILATED AND TREATED WITH PLACEMENT OF A 6 MM X 120 MM STUDY STENT. FOLLOWING POST DILATION, RESIDUAL STENOSIS WAS 0%. ON (B)(6) 2018, THE SUBJECT WAS DISCHARGED WITH ANTIPLATELET MEDICATION. ON (B)(6) 2021, 923 DAYS POST INDEX PROCEDURE, THE SUBJECT PRESENTED WITH UNKNOWN SYMPTOMS AND WAS DIAGNOSED WITH IN-STENT STENOSES. THE SUBJECT WAS RECOMMENDED TO UNDERGO SURGICAL INTERVENTION AS TREATMENT FOR THIS EVENT ON A LATER DATE. ON (B)(6) 2021, THE SUBJECT WAS HOSPITALIZED FOR PLANNED INTERVENTION. ON (B)(6) 2021, 91% STENOSIS IN THE TARGET LESION WITH REFERENCE VESSEL DIAMETER OF 5.5 MM AND 190 MM LESION LENGTH WAS TREATED WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY USING DRUG-COATED BALLOON. POST PROCEDURE, FINAL RESIDUAL STENOSIS WAS 5%. ON (B)(6) 2021, THE EVENT WAS CONSIDERED RECOVERED/RESOLVED AND THE SUBJECT WAS DISCHARGED ON THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820174 ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING NIU BOSTON SCIENTIFIC CORPORATION 24653 0022247651

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R