BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 12052842 · Received June 23, 2021

    Report

    Report Number
    2134265-2021-08063
    Event Type
    Malfunction
    Date Received
    June 23, 2021
    Date of Event
    March 1, 2021
    Report Date
    June 23, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: SYNERGY OUS MR 3.00MM X 38MM STENT DELIVERY SYSTEM, CATHETER WAS RETURNED FOR ANALYSIS. EXAMINATION OF THE STENT IDENTIFIED THE STENT WAS FULLY SEPARATED FROM THE DELIVERY DEVICE. STENT DAMAGE AND STRETCHING WAS IDENTIFIED ALONG THE ENTIRE LENGTH OF THE STENT. A REVIEW OF THE MANUFACTURING STENT PROFILE DATA WAS PERFORMED AND THE STENT OUTER DIAMETER WAS WITHIN MAX CRIMPED STENT PROFILE MEASUREMENT. THE BALLOON CONES WERE REVIEWED, AND THE BALLOON APPEARED TO HAVE BEEN SUBJECTED TO POSITIVE PRESSURE AND THE BALLOON CONES WERE RELAXED. THERE WAS CLEAR DRIED MEDIA INSIDE THE BALLOON AND THERE WERE NO SIGNS OF DAMAGE TO THE BALLOON. EXAMINATION OF THE TIP FOUND NO DAMAGE. EXAMINATION OF THE HYPOTUBE FOUND NO ISSUES. A VISUAL AND TACTILE EXAMINATION OF THE OUTER AND MID-SHAFT SECTION AND A VISUAL EXAMINATION OF THE INNER LUMEN FOUND NO ISSUES. DEVICE WAS TRACKED ON 0.014 GUIDEWIRE WITHOUT ISSUE. DEVICE INFLATED WITH NO ISSUES TO RATED BURST PRESSURE, MAINTAINED PRESSURE AND DEFLATED WITHIN 16 SECONDS. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS.

    Description of Event or Problem · 1

    REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON17JUN2021. IT WAS REPORTED THAT STENT IS HAVING DIFFICULTY IN DEPLOYMENT. LYA 3.00 X 38 SYNERGY II DES DRUG-ELUTING STENT WAS ADVANCED, HOWEVER, DURING THE FIRST INFLATION TO NOMINAL PRESSURE STENT DID NOT DEPLOY CORRECTLY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT IS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    949325 SYNERGY CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC CORPORATION 10623 0024934181

    Patients

    Seq Age Sex Outcome Treatment
    1