BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 16807266 · Received April 25, 2023

    Report

    Report Number
    2124215-2023-19692
    Event Type
    Injury
    Date Received
    April 25, 2023
    Date of Event
    November 14, 2019
    Report Date
    April 25, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    AGENT IDE STUDY. IT WAS REPORTED THAT IN-STENT RESTENOSIS (ISR) OCCURRED. ON (B)(6) 2018 STENOSIS IN THE DISTAL RIGHT CORONARY ARTERY (RCA) WAS TREATED WITH A 4.00 X 12 SYNERGY DRUG ELUTING STENT AND STENOSIS IN THE DIAGONAL WAS TREATED WITH A 2.75 X 12 SYNERGY DRUG ELUTING STENT. ON (B)(6) 2019, 44% ISR IN THE DISTAL RCA WAS TREATED WITH A 3.50 X 6MM NC QUANTUM APEX BALLOON AND 61% ISR OF THE PREVIOUSLY PLACED 2.75 X 12MM SYNERGY STENT PLACED IN THE DIAGONAL WAS TREATED WITH A 3.25 X 6MM NC QUANTUM APEX BALLOON. ADDITIONALLY 52% ISR IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD) WAS TREATED WITH A 4.50 X 6MM NC QUANTUM APEX BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492484 SYNERGY BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM NIQ BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Required Intervention