BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 16086396 · Received January 3, 2023

    Report

    Report Number
    2124215-2022-55334
    Event Type
    Injury
    Date Received
    January 3, 2023
    Date of Event
    July 19, 2022
    Report Date
    January 3, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    AGENT IDE STUDY IT WAS REPORTED THAT IN STENT RESTENOSIS OCCURRED. (B)(6) 2021, PRIOR TO INDEX PROCEDURE, 80% STENOSIS AT LMCA EXTENDING UP TO PROX LCX WAS TREATED WITH SYNERGY DRUG ELUTING STENT OF UNKNOWN SIZE. (B)(6) 2022 PRIOR TO THE INDEX PROCEDURE, THE SUBJECT STARTED EXPERIENCING RECURRENT ANGINA AND WAS REFERRED FOR REPEAT CATHETERIZATION. (B)(6) 2022, DURING THE INDEX PROCEDURE, THE CORONARY ANGIOGRAPHY REVEALED IN STENT RESTENOSIS AT THE LMCA EXTENDING UP TO OSTIAL LCX. LESIONS IN THE LMCA TO PROX LCX WERE TREATED WITH THE STUDY DEVICE, SUCCESSFULLY WITH 10% RESIDUAL STENOSIS AND TIMI FLOW OF 3. THE SUBJECT WAS DISCHARGED ON CLOPIDOGREL ON THE SAME DAY. (B)(6) 2022, 97 DAYS POST THE INDEX PROCEDURE, THE SUBJECT PRESENTED TO THE HOSPITAL WITH THE COMPLAINT OF CHEST PAIN IN RIGHT SIDE WITH EXERCISE. (B)(6) 2022, 103 DAYS POST THE INDEX PROCEDURE, STRESS TEST REVEALED TYPICAL ANGINAL SYMPTOMS WITH ISCHEMIC ECG CHANGES AT A FAIR WORKLOAD. THE SUBJECT WAS DIAGNOSED WITH CORONARY ARTERY DISEASE DUE TO IN STENT RESTENOSIS OF LEFT MAIN CORONARY ARTERY AND LEFT CIRCUMFLEX ARTERY, WHICH WAS TREATED DURING THE INDEX PROCEDURE. AT THE TIME OF THE EVENT, THE SUBJECT WAS ON CLOPIDOGREL. THE SUBJECT WAS RECOMMENDED FOR REPEAT CATHETERIZATION ON A LATER DATE. (B)(6) 2022, 112 DAYS POST INDEX PROCEDURE, 70% IN STENT RESTENOSIS AT LMCA EXTENDING UP TO PROX LCX WAS INITIALLY PREDILATED WITH A 3.5 MM X 12 MM NC EMERGE BALLOON AND A 3.5 MM X 10 MM WOLVERINE CUTTING BALLOON. FOLLOWING THE LESIONS WERE TREATED USING A 4.5 MM X 8 MM (NON BSC DEVICE). POST WHICH, A 4.0 MM X 20 MM SYNERGY MEGATRON DRUG ELUTING STENT WAS PLACED SUCCESSFULLY. THE LESION WAS THEN POST DILATED USING A 4.0 MM X 8 MM AND A 4.5 MM X 8 MM (NON BSC BALLOON), SUCCESSFULLY. POST-REVASCULARIZATION 0% STENOSIS WITH TIMI FLOW OF 3 WAS NOTED. (B)(6) 2022, THE EVENT WAS CONSIDERED RECOVERED/RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653390 SYNERGY BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM NIQ BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Other