BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 12091867 · Received June 30, 2021

    Report

    Report Number
    2134265-2021-07962
    Event Type
    Injury
    Date Received
    June 30, 2021
    Date of Event
    June 10, 2021
    Report Date
    July 15, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A DISSECTION OCCURRED. A PERCUTANEOUS CORONARY TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) WAS PERFORMED ON THE LEFT CIRCUMFLEX (LCX) ARTERY. FOLLOWING PREDILITATION WITH 2.50 X 12 AND 3.00 X 10 NON COMPLIANT (NC) BALLOONS, A 3.50 X 20 SYNERGY II DRUG ELUTING STENT (DES) WAS DEPLOYED IN THE LXC. FOLLOWING POST DILATATION WITH A 3.50 X 10 NC BALLOON, A PROXIMAL EDGE DISSECTION WAS NOTED IN THE PROXIMAL PART OF THE STENT. A 3.0 X 20 SYNERGY STENT WAS DEPLOYED ABOVE THE 3.50 X 20 SYNERGY II DES TO COVER THE DISSECTION AND COMPLETE THE PROCEDURE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT. IT WAS FURTHER REPORTED THAT THE 90% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED LCX. THE LESION WAS PREDILATED WITH A 2.5MM NC BALLOON AND A 3MM NC BALLOON AT NOMINAL PRESSURE. THE LESION WAS POST DILATED WITH A 3.5 X 12MM NC BALLOON AT 14 ATMOSPHERES. IT WAS NOTED THAT THERE WERE NO ISSUES AS THE DISSECTION WAS SEALED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DISSECTION OCCURRED. A PERCUTANEOUS CORONARY TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) WAS PERFORMED ON THE LEFT CIRCUMFLEX (LCX) ARTERY. FOLLOWING PREDILITATION WITH A 3 X 10 NON COMPLIANT (NC) BALLOON, A 3.50 X 20 SYNERGY II DRUG ELUTING STENT (DES) WAS DEPLOYED IN THE LXC. FOLLOWING POST DILATATION WITH A 3.5 X 10 NC BALLOON, A PROXIMAL EDGE DISSECTION WAS NOTED IN THE PROXIMAL PART OF THE STENT. A 3.0 X 20 SYNERGY STENT WAS DEPLOYED ABOVE THE 3.50 X 20 SYNERGY II DES TO COVER THE DISSECTION AND COMPLETE THE PROCEDURE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    991675 SYNERGY CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC CORPORATION 10619 0026661778

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention