BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY¿

    MDR report key: 5548194 · Received April 5, 2016

    Report

    Report Number
    2134265-2016-02551
    Event Type
    Injury
    Date Received
    April 5, 2016
    Date of Event
    March 9, 2016
    Report Date
    March 10, 2016
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE STENT DELIVERY SYSTEM (SDS) WAS RETURNED FOR ANALYSIS. THE STENT HAD DETACHED FROM THE BALLOON. THE ENTIRE STENT APPEARS SEVERELY DAMAGED WITH STENT STRUTS STRETCHED AND BENT. THE BUMPER TIP EXAMINATION FOUND NO ISSUES WITH THE PROFILE. THE BALLOON CONE PROFILES WERE REVIEWED AND NO ISSUES WERE NOTED WITH THE OVERALL BALLOON PROFILE. THE BALLOON WINGS WERE TIGHTLY WRAPPED AND EVENLY FOLDED AND WERE NOT SUBJECTED TO POSITIVE PRESSURE. A VISUAL AND TACTILE EXAMINATION FOUND A HYPOTUBE KINK 46.6CM DISTAL TO THE STRAIN RELIEF. A VISUAL AND TACTILE EXAMINATION FOUND NO ISSUES WITH THE SHAFT POLYMER EXTRUSION PROFILE. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED RIGHT CORONARY ARTERY (RCA). FOLLOWING PREDILATION WITH A NON-BSC BALLOON CATHETER, INTRAVASCULAR ULTRASOUND (IVUS) WAS PERFORMED WITH A NON-BSC IVUS CATHETER. SUBSEQUENTLY, A 3.50 X 24 SYNERGY STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. A NON-BSC GUIDE EXTENSION CATHETER WAS PLACED AND THE PHYSICIAN RE-ADVANCED THE STENT BUT THE STENT STILL FAILED TO CROSS THE LESION. AS THE GUIDE EXTENSION CATHETER WAS DELIVERED MORE THAN THE PERIPHERAL SITE, A SIZE UP BALLOON CATHETER WAS ADVANCED FOR ADDITIONAL DILATION. THE GUIDE EXTENSION CATHETER WAS ADVANCED TO THE PERIPHERAL VESSEL AND THE SAME SYNERGY STENT WAS RE-ADVANCED. HOWEVER, THE STENT WAS ADVANCED TOO FAR AND THE PHYSICIAN HAD TO PUT BACK THE STENT A LITTLE BUT THE STENT WAS DETACHED. THE STENT WAS SUCCESSFULLY RETRIEVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH A 3.50 X 20 SYNERGY STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED RIGHT CORONARY ARTERY (RCA). FOLLOWING PREDILATION WITH A NON-BSC BALLOON CATHETER, INTRAVASCULAR ULTRASOUND (IVUS) WAS PERFORMED WITH A NON-BSC IVUS CATHETER. SUBSEQUENTLY, A 3.50 X 24 SYNERGY¿ STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. A NON-BSC GUIDE EXTENSION CATHETER WAS PLACED AND THE PHYSICIAN RE-ADVANCED THE STENT BUT THE STENT STILL FAILED TO CROSS THE LESION. AS THE GUIDE EXTENSION CATHETER WAS DELIVERED MORE THAN THE PERIPHERAL SITE, A SIZE UP BALLOON CATHETER WAS ADVANCED FOR ADDITIONAL DILATION. THE GUIDE EXTENSION CATHETER WAS ADVANCED TO THE PERIPHERAL VESSEL AND THE SAME SYNERGY¿ STENT WAS RE-ADVANCED. HOWEVER, THE STENT WAS ADVANCED TOO FAR AND THE PHYSICIAN HAD TO PUT BACK THE STENT A LITTLE BUT THE STENT WAS DETACHED. THE STENT WAS SUCCESSFULLY RETRIEVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH A 3.50 X 20 SYNERGY¿ STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203252 SYNERGY¿ CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493926224350 18690506

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention INFLATION DEVICE: EVEREST/MDT