BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 10380852 · Received August 7, 2020

    Report

    Report Number
    2134265-2020-09975
    Event Type
    Injury
    Date Received
    August 7, 2020
    Date of Event
    July 17, 2020
    Report Date
    August 7, 2020
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT DAMAGE POST-DEPLOYMENT OCCURRED. THE 85-90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD) AND RIGHT CORONARY ARTERY (RCA) WITH HEAVILY DISEASED POSTEROLATERAL ARTERY BRANCH (PLB). A NON-BSC WIRE WAS ADVANCED INTO POSTERIOR DESCENDING ARTERY (PDA) FROM RCA AND A 1.5MM ROTAPRO WAS USED TO SUCCESSFULLY ABLATE CALCIUM IN PROXIMAL TO MID RCA AND WAS TREATED WITH A WOLVERINE CUTTING BALLOON. A 2.5X48MM SYNERGY DRUG-ELUTING STENT (DES) WAS ADVANCED FOR TREATMENT IN THE PDA AND DISTAL RCA, A 3.5X48MM SYNERGY DES IN THE MID RCA AND A 4X20MM SYNERGY DES IN THE PROXIMAL RCA. ALL STENTS WERE POST DILATED WITH NC EMERGE BALLOON CATHETERS. SUBSEQUENTLY, A NON-BSC GUIDEWIRE WAS ADVANCED THROUGH THE CELLS AT THE BIFURCATION/OSTIUM OF THE PLB AND A 6F GUIDEZILLA II CATHETER-GUIDE WAS USED TO PROVIDE ADDITIONAL SUPPORT AS THERE WERE HAVING ISSUE PASSING THE BALLOONS FOR DILATION. A 2.25X28MM SYNERGY DES WAS ATTEMPTED TO CROSS THE CELL OF THE IMPLANTED 2.5X48MM SYNERGY DES BUT FAILED. THE DEVICE WAS REMOVED AND AFTER MORE DILATATIONS IT WAS SUCCESSFULLY POSITIONED IN THE PLB. HOWEVER, UNDER ANGIOGRAPHY, IT WAS NOTICED THAT THE 2.5X48MM SYNERGY DES WAS DAMAGED AFTER CROSSING BIFURCATION CELL WITH 2.5X28 SYNERGY DES. THE CONTRALATERAL SIDE WALL OF THE STENT WAS RAISED FROM THE WALL. THE 2.5X28MM SYNERG DES WAS REMOVED AND TREAT THE PLB WITH A NON-BSC DRUG-COATED BALLOON AND THE DAMAGED IMPLANTED STENT WAS REPAIRED USING A NC EMERGE POST-DILATION BALLOON. THE PROCEDURE WAS COMPLETED AND NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844126 SYNERGY CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC CORPORATION 10632 0024486712

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention GUIDE WIRE: GUIDEZILLA II 6F| STENT: 2.5X28 SYNERGY DRUG-ELUTING STENT