BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 8078045 · Received November 16, 2018

    Report

    Report Number
    2134265-2018-62914
    Event Type
    Injury
    Date Received
    November 16, 2018
    Date of Event
    September 15, 2018
    Report Date
    November 16, 2018
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    UDI-DI
    08714729840411
    PMA / PMN Number
    P150003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT.

    Description of Event or Problem · 1

    (B)(6) CLINICAL STUDY. IT WAS REPORTED THAT IN-STENT RESTENOSIS OCCURRED. IN (B)(6) 2018, THE PATIENT'S CLINICAL STATUS ASSESSMENT INDICATED THE CONDITION AS "SEVER" MITRAL REGURGITATION WITH CLASS 3 HEART FAILURE SYMPTOMS AND WAS REFERRED FOR CARDIAC CATHETERIZATION. CORONARY ANGIOGRAPHY AND INDEX PROCEDURE WAS PERFORMED. TARGET LESION WAS LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) WITH 95% STENOSIS AND WAS 10 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.50 MM. THE LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 3.00 X 38MM SYNERGY STUDY STENT. FOLLOWING POST DILATATION, THE RESIDUAL STENOSIS WAS 0% AND HAS TIMI 3 FLOW. ON THE SAME DAY, THE PATIENT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY. IN (B)(6) 2018, THE PATIENT PRESENTED WITH THE COMPLAINT OF SEVER MITRAL REGURGITATION AND WAS REFERRED FOR CARDIAC CATHETERIZATION. IN (B)(6) 2018, CARDIAC CATHETERIZATION REVEALED A 100% IN-STENT RESTENOSIS (ISR) OF THE SYNERGY STENT IN THE PROXIMAL RCA. COLLATERALS IN THE MID AND DISTAL VESSEL. TIMI 0 ANTEGRADE FLOW WAS NOTED. THE ISR WAS THEN TREATED WITH DEPLOYMENT OF A 3.0X12MM, 3.0X38MM AND 3.0X38MM NON-BSC STENTS EXTENDING UP TO DISTAL RCA IN OVERLAPPING FASHION. FOLLOWING POST DILATATION, THE RESIDUAL STENOSIS WAS 0% WITH TIMI 3 FLOW WAS ACHIEVED. POST PROCEDURE ANGIOGRAPHY OF RCA VESSEL WAS PERFORMED WHICH REVEALED PATENT STENTS DEPLOYED DURING REVASCULARIZATION IN PROXIMAL RCA EXTENDING UP TO DISTAL RCA. THE EVENT WAS CONSIDERED "RESOLED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    917352 SYNERGY BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM NIQ BOSTON SCIENTIFIC CORPORATION 10607 0021368462 08714729840411

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention