BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 14619756 · Received June 7, 2022

    Report

    Report Number
    2134265-2022-05754
    Event Type
    Injury
    Date Received
    June 7, 2022
    Date of Event
    December 6, 2021
    Report Date
    June 18, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SYNERGY (B)(6) REGISTRY. IT WAS REPORTED THAT IN-STENT RESTENOSIS OCCURRED. IN (B)(6) 2020, THE SUBJECT WAS REFERRED FOR CARDIAC CATHETERIZATION AND INDEX PROCEDURE WAS PERFORMED ON THE SAME DAY. THE TARGET LESION 1 WAS LOCATED IN THE RIGHT POSTERIOR ATRIOVENTRICULAR (R-PAV) EXTENDING UP TO (R-PAV) WITH 80% STENOSIS AND WAS 26 MM LONG, WITH A REFERENCE VESSEL DIAMETER OF 3.3 MM. THE TARGET LESION 1 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF 2.75 MM X 28 MM SYNERGY STENT SYSTEM. FOLLOWING POST-DILATION, THE RESIDUAL STENOSIS WAS NOTED TO BE 0%. THREE DAYS LATER, THE SUBJECT WAS DISCHARGED ON TICAGRELOR AND ASPIRIN. IN (B)(6) 2021, THE SUBJECT WAS DIAGNOSED WITH IN-STENT RESTENOSIS AND WAS HOSPITALIZED FOR FURTHER EVALUATION AND TREATMENT. ON THE FOLLOWING DAY, THE SUBJECT WAS REFERRED FOR CORONARY ANGIOGRAPHY WHICH REVEALED 90% STENOSIS NOTED IN R-PAV EXTENDING UP-TO R-PAV WAS TREATED WITH PERCUTANEOUS CORONARY INTERVENTION (PCI). POST INTERVENTION, RESIDUAL STENOSIS WAS 0%. THE RATIONALE OF INTERVENTION WAS ANGIOGRAPHIC FINDING WITHOUT SYMPTOMS OR OBJECTIVE SIGNS OF ISCHEMIA. TWO DAYS LATER, THE EVENT WAS CONSIDERED TO BE RECOVERED AND RESOLVED AND THE SUBJECT WAS DISCHARGED ON TICAGRELOR AND ASPIRIN.

    Description of Event or Problem · 0

    SYNERGY CHINA REGISTRY IT WAS REPORTED THAT IN-STENT RESTENOSIS OCCURRED. IN DECEMBER 2020, THE SUBJECT WAS REFERRED FOR CARDIAC CATHETERIZATION AND INDEX PROCEDURE WAS PERFORMED ON THE SAME DAY. THE TARGET LESION 1 WAS LOCATED IN THE RIGHT POSTERIOR ATRIOVENTRICULAR (R-PAV) EXTENDING UP TO (R-PAV) WITH 80% STENOSIS AND WAS 26 MM LONG, WITH A REFERENCE VESSEL DIAMETER OF 3.3 MM. THE TARGET LESION 1 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF 2.75 MM X 28 MM SYNERGY STENT SYSTEM. FOLLOWING POST-DILATION, THE RESIDUAL STENOSIS WAS NOTED TO BE 0%. THREE DAYS LATER, THE SUBJECT WAS DISCHARGED ON TICAGRELOR AND ASPIRIN. IN (B)(6) 2021, THE SUBJECT WAS DIAGNOSED WITH IN-STENT RESTENOSIS AND WAS HOSPITALIZED FOR FURTHER EVALUATION AND TREATMENT. ON THE FOLLOWING DAY, THE SUBJECT WAS REFERRED FOR CORONARY ANGIOGRAPHY WHICH REVEALED 90% STENOSIS NOTED IN R-PAV EXTENDING UP-TO R-PAV WAS TREATED WITH PERCUTANEOUS CORONARY INTERVENTION (PCI). POST INTERVENTION, RESIDUAL STENOSIS WAS 0%. THE RATIONALE OF INTERVENTION WAS ANGIOGRAPHIC FINDING WITHOUT SYMPTOMS OR OBJECTIVE SIGNS OF ISCHEMIA. TWO DAYS LATER, THE EVENT WAS CONSIDERED TO BE RECOVERED AND RESOLVED AND THE SUBJECT WAS DISCHARGED ON TICAGRELOR AND ASPIRIN. IT WAS FURTHER REPORTED THAT IN DECEMBER 2021, MEDICATION WAS ALSO GIVEN TO TREAT THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    665784 SYNERGY BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM NIQ BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention| O| H