BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY¿

    MDR report key: 6157590 · Received December 9, 2016

    Report

    Report Number
    2134265-2016-11144
    Event Type
    Malfunction
    Date Received
    December 9, 2016
    Date of Event
    September 5, 2016
    Report Date
    November 20, 2016
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. (B)(4). DEVICE EVALUATED BY MFR: THE STENT DELIVERY SYSTEM WAS RETURNED FOR ANALYSIS. A VISUAL AND TACTILE EXAMINATION OF THE DEVICE FOUND THAT THERE WAS NO HYPO TUBE KINKS NOTED. NO ISSUES WITH MID SHAFT, INNER OR OUTER POLYMER EXTRUSION. THE CRIMPED STENT, BALLOON SECTIONS OF THE DEVICE WERE VISUALLY AND MICROSCOPICALLY EXAMINED AND STRUT 4 FROM THE PROXIMAL END OF THE STENT IS LIFTED AND BENT BACK DISTALLY. STRUT 5 FROM THE PROXIMAL END OF STENT IS SLIGHTLY FLARED. STRUT 9 AND 10 FROM THE PROXIMAL END OF THE STENT ARE TWISTED AND OUT OF FORMATION. NO ISSUES NOTED WITH BALLOON. THE TIP WAS VISUALLY AND MICROSCOPICALLY EXAMINED AND NO ISSUES WERE NOTED. 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

    REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 20-NOV-2016 IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED.   THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY. FOLLOWING PRE-DILATION, A 3.00 X 20 SYNERGY¿ DRUG ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE 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
    811175 SYNERGY¿ CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493926220300 0019064308

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR