BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELUVIATM DRUG-ELUTING VASCULAR STENT SYSTEM

    MDR report key: 7948831 · Received October 9, 2018

    Report

    Report Number
    2134265-2018-61733
    Event Type
    Injury
    Date Received
    October 9, 2018
    Date of Event
    May 1, 2018
    Report Date
    October 30, 2018
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIU
    PMA / PMN Number
    P180011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    EVENT DATE WAS NOT REPORTED AND APPROXIMATED (B)(6) 2018.

    Description of Event or Problem · 0

    IMPERIAL CLINICAL STUDY. IT WAS REPORTED THAT IN-STENT RESTENOSIS OCCURRED. (B)(6) 2016 - INDEX PROCEDURE WAS PERFORMED TO TREAT THE 100% STENOSED LEFT LEG MID SUPERFICIAL FEMORAL ARTERY (SFA) THAT WAS 60 MM LONG WITH A PROXIMAL REFERENCE VESSEL DIAMETER OF 4.8 MM AND DISTAL VESSEL DIAMETER OF 4.8 MM, CLASSIFIED AS TASC II A LESION. THE LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 6.0 MM X 80 MM STUDY STENT. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. THE PATIENT WAS DISCHARGED THE NEXT DAY ON DUAL ANTIPLATELET THERAPY. (B)(6) 2018 - THE PATIENT WAS DIAGNOSED WITH IN-STENT RESTENOSIS OF THE STUDY STENT LOCATED IN THE LEFT SFA. (B)(6) 2018 - THE PATIENT WAS HOSPITALIZED FOR FURTHER EVALUATION AND POSSIBLE TREATMENT. 861 DAYS POST INDEX PROCEDURE, 100% ISR OF STUDY STENT LOCATED IN LEFT MID SFA WAS TREATED WITH DRUG COATED BALLOON ANGIOPLASTY USING 35.5 MM X 120 MM LUMINOR BALLOON (TVR). THE FOLLOWING DAY THE EVENT WAS CONSIDERED RESOLVED AND THE PATIENT WAS DISCHARGED ON THE SAME DAY. IT WAS FURTHER REPORTED THAT IN (B)(6) 2018, THE PATIENT PRESENTED TO THE HOSPITAL WITH INCREASING CLAUDICATION IN THE LEFT CALF. THE PATIENT WAS ALSO EXPERIENCING PAIN WHICH HAS BEEN ONGOING FOR FOUR TO FIVE MONTHS AND CAN ONLY WALK 100 METERS BEFORE IT GETS DIFFICULT. A CLINICAL EXAMINATION REVEALED THAT ARTERIAL PULSATIONS IN THE RIGHT LOWER LIMB ARE PALPABLE, FEMORAL, POPLITEAL AND AT THE FOOT. ON THE LEFT, THE PULSATION ARE FEMORAL. AN ULTRASOUND WAS PERFORMED WHICH REVEALED PROGRESSIVELY DECREASINGLY ARTERIAL FLOW ALONG THE LEFT FEMORAL POPLITEAL AXIS WITHIN THE STENT. (B)(6) 2018, THE PATIENT VISITED THE HOSPITAL FOR THE SCHEDULED COMPUTERIZED TOMOGRAPHY (CT) ANGIOGRAM, WHICH REVEALED THE STENT WAS OCCLUDED. A CORRECTION WAS ALSO REPORTED FOR THE TREATMENT THAT TOOK PLACE IN (B)(6) 2018, 861 DAYS POST INDEX PROCEDURE, IT WAS PREVIOUSLY REPORTED THE LEFT MID SFA WAS TREATED WITH DRUG COATED BALLOON ANGIOPLASTY USING A 35.5 MM X 120 MM LUMINOR BALLOON (TVR). THIS HAS BEEN CORRECTED TO A 5 MM X 120 MM LUMINOR 35 BALLOON (TVR). POST PROCEDURE, THE RESIDUAL STENOSIS WAS 10%.

    Additional Manufacturer Narrative · 1

    EVENT DATE WAS NOT REPORTED AND APPROXIMATED (B)(6) 2018.

    Description of Event or Problem · 1

    (B)(4) CLINICAL STUDY. IT WAS REPORTED THAT IN-STENT RESTENOSIS OCCURRED. (B)(6) 2016 - INDEX PROCEDURE WAS PERFORMED TO TREAT THE 100% STENOSED LEFT LEG MID SUPERFICIAL FEMORAL ARTERY (SFA) THAT WAS 60 MM LONG WITH A PROXIMAL REFERENCE VESSEL DIAMETER OF 4.8 MM AND DISTAL VESSEL DIAMETER OF 4.8 MM, CLASSIFIED AS TASC II A LESION. THE LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 6.0 MM X 80 MM STUDY STENT. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. THE PATIENT WAS DISCHARGED THE NEXT DAY ON DUAL ANTIPLATELET THERAPY. (B)(6) 2018 - THE PATIENT WAS DIAGNOSED WITH IN-STENT RESTENOSIS OF THE STUDY STENT LOCATED IN THE LEFT SFA. (B)(6) 2018 - THE PATIENT WAS HOSPITALIZED FOR FURTHER EVALUATION AND POSSIBLE TREATMENT. THE 861 DAYS POST INDEX PROCEDURE, 100% ISR OF STUDY STENT LOCATED IN LEFT MID SFA WAS TREATED WITH DRUG COATED BALLOON ANGIOPLASTY USING 35.5 MM X 120 MM LUMINOR BALLOON (TVR). THE FOLLOWING DAY THE EVENT WAS CONSIDERED RESOLVED AND THE PATIENT WAS DISCHARGED ON THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788072 ELUVIATM DRUG-ELUTING VASCULAR STENT SYSTEM STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING NIU BOSTON SCIENTIFIC CORPORATION 24620 18754444

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention