BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 13810190 · Received March 18, 2022

    Report

    Report Number
    2134265-2022-02582
    Event Type
    Injury
    Date Received
    March 18, 2022
    Date of Event
    January 27, 2022
    Report Date
    March 17, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    PMA / PMN Number
    P150003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    AGENT IDE . IT WAS REPORTED THAT UNSTABLE ANGINA AND IN-STENT RESTENOSIS OCCURRED. ON (B)(6) 2017, 85% STENOSIS WAS TREATED WITH ANGIOPLASTY USING A 3.00 X 28MM SYNERGY DRUG ELUTING STENT IMPLANTED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). ON (B)(6) 2022, THE SUBJECT PRESENTED WITH UNSTABLE ANGINA (BRAUNWALD CLASSIFICATION IIB) AND WAS REFERRED FOR THE AGENT IDE STUDY. CARDIAC CATHETERIZATION REVEALED 90% IN-STENT RESTENOSIS AT THE MID LAD. THE TARGET LESION LOCATED AT THE PROXIMAL LAD WAS 14 MM LONG WITH A REFERENCE VESSEL DIAMETER WAS 3.6 MM. THE TARGET LESION WAS PREDILATED WITH 4.0 MM X 20 MM BALLOON WITH 0% RESIDUAL STENOSIS. FOLLOWING PRE-DILATION, THE LESION WAS TREATED WITH 3.50 MM X 20 MM STUDY BALLOON. POST INFLATION, THERE WAS EVIDENCE OF TYPE C DISSECTION AT THE PROXIMAL EDGE OF THE STENT ANGIOGRAPHICALLY VISIBLE AND WAS CONFIRMED BY OPTICAL COHERENCE TOMOGRAPHY. TO TREAT THE LOCATION IN THE PROXIMAL LAD JUST BEYOND THE LAD OSTIUM, A 3.5MM X 20MM SYNERGY CORONARY STENT WAS POSITIONED AND DEPLOYED TO OVERLAP WITH THE PREVIOUS STENT BACK TO THE OSTIUM OF THE LAD COVERING THE SITE OF THE DISSECTION. THE STENT WAS INFLATED AND POST-DILATION WAS PERFORMED USING A 4.0 MM X 8MM NON-COMPLIANT BALLOON AT THE PROXIMAL PORTION OF THE STENT. POST DILATION WAS PERFORMED WITH 0% RESIDUAL STENOSIS AND TIMI FLOW 3 WAS NOTED. THE SUBJECT WAS DISCHARGED ON DUAL ANTIPLATELET MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17931 SYNERGY BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM NIQ BOSTON SCIENTIFIC CORPORATION 10605

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Other| R