BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM

    MDR report key: 12775985 · Received November 8, 2021

    Report

    Report Number
    2134265-2021-13903
    Event Type
    Injury
    Date Received
    November 8, 2021
    Date of Event
    October 19, 2021
    Report Date
    November 8, 2021
    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

    (B)(6).

    Description of Event or Problem · 0

    (B)(6) STUDY. IT WAS REPORTED THERE WAS IN-STENT THROMBOSIS. THE SUBJECT WAS ENROLLED IN THE (B)(6) STUDY ON (B)(6) 2019 AND THE INDEX PROCEDURE WAS PERFORMED ON THE SAME DAY. THE TARGET LESION WAS LOCATED IN RIGHT DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) INVOLVING PROXIMAL POPLITEAL ARTERY WITH 100% STENOSIS AND WAS 140 MM LONG WITH A PROXIMAL REFERENCE VESSEL DIAMETER OF 5.5 MM AND DISTAL REFERENCE VESSEL DIAMETER OF 5 MM AND WAS CLASSIFIED AS TASC II B LESION. THE TARGET LESION WAS TREATED WITH PRE-DILATATION FOLLOWED BY PLACEMENT OF 6 MM X 120 MM AND 6 MM X 60 MM. FOLLOWING POST DILATION, RESIDUAL STENOSIS WAS 20%, HENCE A 6 MM X 40 MM STUDY STENT WAS USED. ON (B)(6) 2019, THE SUBJECT WAS DISCHARGED WITH ANTIPLATELET THERAPY. ON (B)(6) 2021, 928 DAYS POST INDEX PROCEDURE, THE SUBJECT PRESENTED TO THE CLINIC WITH COMPLAINTS OF PROGRESSIVE PAIN IN THE RIGHT LEG, PARTICULARLY IN THE RIGHT CALF WITH A MINIMAL WALKING DISTANCE FOR THE LAST THREE TO FOUR WEEKS APPROX. AND THE PAIN IS CURRENTLY AGGRAVATED AT REST AND DURING NIGHT IN THE POPLITEAL CAVITY. ON PHYSICAL EXAMINATION, THE RIGHT LEG EXTREMITY SHOWED COLDER FOOT THAN THE LEFT AND NOT PALPABLE WITH CERTAINTY ON BOTH THE SIDES. BASED ON THE SYMPTOMS SUBJECT WAS DIAGNOSED WITH THROMBOTIC INSTENT RE-OCCLUSION OF A FEMORALIS SUPERFICIALIS AND A. POPLITEA 1 RIGHT LEG. UPON CONSULTATION, THE SUBJECT WAS RECOMMENDED TO UNDERGO INTERVENTIONAL PROCEDURE AS A TREATMENT FOR THE EVENT. ON THE SAME DAY, THE SUBJECT WAS HOSPITALIZED, FOR FURTHER EVALUATION AND TREATMENT. PRE-INTERVENTIONAL ANGIOGRAPHY PERFORMED REVEALED, UNDISRUPTED PRESSURE CURVE AT THE TIP OF THE SHEATH IN THE MID SUPERFICIAL FEMORAL ARTERY. FROM THE DISTAL FEMORAL ARTERY IS THE START OF THE STENT SECTION WITH COMPLETE OCCLUSION OF THE RIGHT DISTAL SUPERFICIAL FEMORAL ARTERY AND THE POPLITEAL ARTERY IN THE PROXIMAL AND CENTRAL SEGMENT. THE STENTS ARE PARTLY INDENTED DUE TO CALCIFIED SECTIONS. DISTAL POPLITEAL ARTERY WITH FILIFORM REPERFUSION. TIBIOFIBULAR TRUNK WITH DIFFUSE STENOSIS, OPEN. ANTERIOR TIBIAL ARTERY AND FIBULAR ARTERY ARE ALSO OPEN IN THE FURTHER COURSE. POSTERIOR TIBIAL ARTERY IS OPEN IN THE PROXIMAL REGION, THEN CHRONICALLY OCCLUDED. ON (B)(6) 2021, 928 DAYS POST INDEX PROCEDURE, 100% STENOSIS IN THE TARGET LESION (RIGHT DISTAL SFA INCLUDING PROXIMAL POPLITEAL ARTERY) WITH 250 MM LESION LENGTH AND REFERENCE VESSEL DIAMETER OF 5 MM WAS TREATED BY ROTATIONAL THROMBECTOMY FIXATION OF THE NEOINTIMAL HYPERPLASIA AND RESIDUAL THROMBI IN THE PROXIMAL SEGMENT OF THE STENT CHAIN USING 6 MM X 140 MM NON-BSC STENT. LATER, DRUG-COATED BALLOON ANGIOPLASTY WAS PERFORMED USING 4 MM RANGER BALLOON IN THE POPLITEAL ARTERY, OVERLAPPING INTO THE TIBIOFIBULAR TRUNK, SUBSEQUENTLY EXTENDING PROXIMALLY USING 5 MM NON-BSC BALLOON. FOLLOWED BY USING A NON-BSC CATHETER AND BALLOON, ASPIRATION MANEUVER FROM THE ANTERIOR TIBIAL ARTERY AND FIBULAR ARTERY TO REMOVE THROMBOEMBOLISMS. FINALLY, STENTING OVER A SMALL CALCIFICATION WITH RESIDUAL STENOSIS IN THE OUTFLOW OF THE TIBIOFIBULAR TRUNK WAS PERFORMED USING 4 MM SYNERGY STENT. POST TREATMENT, RESIDUAL STENOSIS WAS 30% WITH NO THROMBUS SEEN IN TREATED VESSEL AT THE END OF THE PROCEDURE. POST FOLLOW UP DUPLEX ULTRASOUND REVEALED PUNCTURE SITE WITHOUT BLEEDING, DIFFUSE HEMATOMA WITHOUT ACTIVE PERFUSION, NO PSEUDOANEURYSM. FEMORAL VEIN WITH VARIATION ON RESPIRATION, NO AV FISTULA. SUPERFICIAL FEMORAL ARTERY AND POPLITEAL ARTERY STILL WITH DIFFUSE CHANGES WITH TRIPHASIC FLOW WITHOUT STENOSIS. OPEN TIBIOFIBULAR TRUNK AND ANTERIOR TIBIAL ARTERY AND FIBULAR ARTERY WERE STRONGLY PERFUSED AND POSTERIOR TIBIAL ARTERY CHRONICALLY OCCLUDED. ON (B)(6) 2021, THE SUBJECT WAS DISCHARGED HOME WITH THE ADVICE OF DUAL ANTIPLATELET THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1671815 ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING NIU BOSTON SCIENTIFIC CORPORATION 24653 0023071978

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention