BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 10225463 · Received July 2, 2020

    Report

    Report Number
    2134265-2020-08301
    Event Type
    Injury
    Date Received
    July 2, 2020
    Date of Event
    June 12, 2020
    Report Date
    August 24, 2020
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    UDI-DI
    08714729973478
    PMA / PMN Number
    P150003/S039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR.: SYNERGY II DES STENT DELIVERY SYSTEM (SDS) WAS RETURNED FOR ANALYSIS WITHOUT THE STENT, THE HYPOTUBE SHAFT AND THE MANIFOLD HUB AND ON A GUIDE WIRE AND INSIDE A GUIDECATHETER. THE FGB, UPN AND SIZE PROVIDED BY THE CUSTOMER FOR THIS DEVICE CANNOT BE CONFIRMED DUE TO THE MISSING MANIFOLD HUB WHICH CONTAINS THE CATHETER LOT AND SERIAL NUMBER AS WELL AS THE PRODUCT NAME AND SIZE. AN EMERGE 3.00X15MM DEVICE WAS ALSO NOTED TO BE INSIDE THE SAME GUIDECATHETER BUT ON A DIFFERENT WIRE. THE DEVICE WAS RETURNED WITHOUT A STENT. A MANUFACTURING CRIMPS STENT DATA WAS PERFORMED AND SINCE THE SDS WAS NOT RETURNED WITH THE STENT ALL 300 RESULTS RECORDED DURING CRIMPING OF THIS FGB WERE REVIEWED. ALL DEVICES PASSED THE CRIMPING MEASUREMENT TEST WITH RESULTS WITHIN MAX CRIMPED STENT PROFILE MEASUREMENT. THE BALLOON CONES WERE REVIEWED, AND SIGNS OF POSITIVE PRESSURE APPLIED TO THE CONES WERE NOTED AS ITS WINGS WERE RELAXED AND NOT TIGHTLY FOLDED. RED/BROWN BLOOD LIKE SUBSTANCE NOTED INSIDE/OUTSIDE THE BALLOON CONES. A VISUAL AND MICROSCOPIC EXAMINATION OF THE BUMPER TIP SHOWED NO SIGNS OF TIP DAMAGE. NO INSPECTION OF THIS REGION WAS PERFORMED AS IT WAS NOT RETURNED WITH THE DEVICE. A VISUAL AND TACTILE EXAMINATION OF THE OUTER AND MID-SHAFT SECTION FOUND A BREAK IN THE SHAFT POLYMER EXTRUSION MEASURED AT 29 CM PROXIMAL TO THE DISTAL END OF THE TIP. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. A 5.00 X 32MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE STENT CAME OFF THE BALLOON. THE DISLODGED DEVICE WAS SNARED FROM THE PATIENT'S BODY. NO PATIENT COMPLICATIONS WERE REPORTED.

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. A 5.00 X 32MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE STENT CAME OFF THE BALLOON. THE DISLODGED DEVICE WAS SNARED FROM THE PATIENT'S BODY. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    689155 SYNERGY CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC CORPORATION 10622 0024183139 08714729973478

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention