BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM

    MDR report key: 12790837 · Received November 10, 2021

    Report

    Report Number
    2134265-2021-14059
    Event Type
    Injury
    Date Received
    November 10, 2021
    Date of Event
    September 22, 2021
    Report Date
    November 30, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6).

    Additional Manufacturer Narrative · 0

    A1. PATIENT IDENTIFIER: (B)(6). B5. EVENT DESCRIPTION WAS UPDATED WITH ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    (B)(6) STUDY. IT WAS REPORTED THAT THE SUBJECT WAS DIAGNOSED WITH AN IN-STENT RESTENOSIS. 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 THE LEFT DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) INVOLVING THE PROXIMAL POPLITEAL ARTERY. THE LESION WAS 100% STENOSED AND 80MM LONG WITH A PROXIMAL VESSEL DIAMETER OF 5.5MM AND DISTAL REFERENCE VESSEL DIAMETER OF 5MM. THE LESION WAS CLASSIFIED AS TASC II B LESION. A 6MM X 120MM ELUVIA STENT WAS SELECTED FOR TREATMENT OF THE TARGET LESION. FOLLOWING POST DILATION, THE RESIDUAL STENOSIS WAS 20%. THE SUBJECT WAS DISCHARGED ON THE SAME DAY WITH ANTIPLATELET MEDICATIONS. ON (B)(6) 2021, 933 DAYS POST INDEX PROCEDURE, THE SUBJECT WAS DIAGNOSED WITH AN IN-STENT STENOSIS IN THE LEFT SUPRAGENUALE POPLETEAL ARTERY. NO ACTION WAS TAKEN AT THE TIME OF DIAGNOSIS. HOWEVER, THE SUBJECT WAS RECOMMENDED TO UNDERGO INTERVENTIONAL PROCEDURE AS A TREATMENT FOR THIS EVENT. ON (B)(6) 2021, THE SUBJECT WAS HOSPITALIZED FOR A PLANNED INTERVENTION. THE LESION WAS LOCATED IN THE LEFT DISTAL SFA AND WAS 80% STENOSED WITH A LESION LENGTH OF 10MM AND REFERENCE VESSEL DIAMETER OF 5MM. TREATMENT WAS PERFORMED WITH A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY AND A DRUG COATED BALLOON. POST TREATMENT, THE RESIDUAL STENOSIS WAS 5%. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED.

    Description of Event or Problem · 0

    EMINENT CLINICAL STUDY , IT WAS REPORTED THAT THE SUBJECT WAS DIAGNOSED WITH AN IN-STENT RESTENOSIS. THE SUBJECT WAS ENROLLED IN THE EMINENT STUDY ON 04-MAR-2019 AND THE INDEX PROCEDURE WAS PERFORMED ON THE SAME DAY. THE TARGET LESION WAS LOCATED IN THE LEFT DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) INVOLVING THE PROXIMAL POPLITEAL ARTERY. THE LESION WAS 100% STENOSED AND 80MM LONG WITH A PROXIMAL VESSEL DIAMETER OF 5.5MM AND DISTAL REFERENCE VESSEL DIAMETER OF 5MM. THE LESION WAS CLASSIFIED AS TASC II B LESION. A 6MM X 120MM ELUVIA STENT WAS SELECTED FOR TREATMENT OF THE TARGET LESION. FOLLOWING POST DILATION, THE RESIDUAL STENOSIS WAS 20%. THE SUBJECT WAS DISCHARGED ON THE SAME DAY WITH ANTIPLATELET MEDICATIONS. ON 22-SEP-2021, 933 DAYS POST INDEX PROCEDURE, THE SUBJECT PRESENTED WITH UNKNOWN SYMPTOMS AND WAS DIAGNOSED WITH AN IN-STENT STENOSIS IN THE LEFT SUPERFICIAL POPLITEAL ARTERY. ON THE SAME DAY, DUPLEX ULTRASOUND OF THE LEFT LIMB REVEALED ECHOGENIC PLAQUE IN THE COMMON FEMORAL ARTERY AND AT THE LEVEL OF THE FEMORAL BIFURCATION. STENOSIS RANGING FROM 75%-99% WITH LESION LENGTH 2.5CM WAS NOTED IN THE DISTAL PART OF THE STENT AND EXTENDING INTO THE POPLITEAL ARTERY. NO ACTION WAS TAKEN AT THE TIME OF DIAGNOSIS. HOWEVER, THE SUBJECT WAS RECOMMENDED TO UNDERGO INTERVENTIONAL PROCEDURE AS A TREATMENT FOR THIS EVENT. PLAVIX WAS PRESCRIBED. ON 07-OCT-2021, THE SUBJECT WAS HOSPITALIZED FOR A PLANNED INTERVENTION. ANGIOGRAPHY OVER THE SHEATH REVEALED HIGH-GRADE IN-STENT STENOSIS JUST ABOVE THE KNEE JOINT SPACE. THE LESION WAS LOCATED IN THE LEFT DISTAL SFA INVOLVING PROXIMAL POPLITEAL ARTERY. THE LESION WAS 80% STENOSED AND HAD A LENGTH OF 10MM AND REFERENCE VESSEL DIAMETER OF 5MM. TREATMENT WAS PERFORMED WITH A 5MM X 80MM PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON AND A 5MM X 40MM DRUG ELUTING BALLOON. POST TREATMENT, THE RESIDUAL STENOSIS WAS 5% AND CONTROL ANGIOGRAPHY SHOWED IMPROVED PATENCY. THE EVENT WAS CONSIDERED TO BE RECOVERED OR RESOLVED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1686631 ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING NIU BOSTON SCIENTIFIC CORPORATION 24653 0023027644

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Hospitalization| R| O