BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 8824412 · Received July 24, 2019

    Report

    Report Number
    2134265-2019-08706
    Event Type
    Malfunction
    Date Received
    July 24, 2019
    Date of Event
    May 14, 2019
    Report Date
    July 24, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR.: SYNERGY OUS MR 2.25 X 32 MM STENT DELIVERY SYSTEM WAS RETURNED FOR ANALYSIS. A VISUAL EXAMINATION OF THE STENT FOUND SIGNS OF STENT DAMAGE. STENT STRUTS ON THE 1TH PROXIMAL STENT STRUT ROW WAS NOTED TO BE LIFTED AND PULLED DISTALLY. THE UNDAMAGED STENT OUTER DIAMETER WAS MEASURED AND THE RESULT WAS WITHIN MAXIMUM CRIMPED STENT PROFILE MEASUREMENT. THE BALLOON CONES WERE REVIEWED, AND NO ISSUES WERE NOTED. THE BALLOON WINGS WERE TIGHTLY WRAPPED AND EVENLY FOLDED AND WERE NOT SUBJECTED TO POSITIVE PRESSURE. A VISUAL AND MICROSCOPIC EXAMINATION OF THE BUMPER TIP SHOWED NO SIGNS OF DAMAGE. A VISUAL AND TACTILE EXAMINATION OF THE HYPOTUBE FOUND NO ISSUES. A VISUAL AND TACTILE EXAMINATION OF THE OUTER AND INNER LUMEN AND MID-SHAFT SECTION FOUND NO ISSUES ALONG THE SHAFT POLYMER EXTRUSION. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS.

    Description of Event or Problem · 1

    REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 02-JUL-2019. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY. AFTER PRE-DILATATION WAS PERFORMED, A 2.25 X 32 SYNERGY DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616200 SYNERGY CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC CORPORATION 10622 0023316055

    Patients

    Seq Age Sex Outcome Treatment
    1