BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY¿

    MDR report key: 6195061 · Received December 21, 2016

    Report

    Report Number
    2134265-2016-11830
    Event Type
    Malfunction
    Date Received
    December 21, 2016
    Date of Event
    October 13, 2016
    Report Date
    December 6, 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: STENT DELIVERY SYSTEM (SDS) WAS RETURNED FOR ANALYSIS. A VISUAL EXAMINATION OF THE STENT FOUND THAT THE STENT STRUTS ARE LIFTED FROM THE BALLOON AND DEFORMED ON ROWS 10 TO 17 FROM THE PROXIMAL END OF THE STENT. THE UNDAMAGED SECTION OF THE CRIMPED STENT OD (OUTER DIAMETER) WAS MEASURED AND MET SPECIFICATION. THE DISTAL EDGE OF THE BUMPER TIP SHOWED SIGNS OF DAMAGE. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED TO THE DELIVERY SYSTEM.. THE BALLOON BODY WAS REVIEWED AND NO ISSUES WERE NOTED WITH THE OVERALL BALLOON. THE BALLOON WINGS WERE TIGHTLY WRAPPED AND EVENLY FOLDED AND WERE NOT SUBJECTED TO POSITIVE PRESSURE. A VISUAL AND TACTILE EXAMINATION FOUND NO KINKS ALONG THE HYPOTUBE SHAFT. A VISUAL AND TACTILE EXAMINATION OF THE OUTER AND MID-SHAFT SECTION FOUND NO ISSUES WITH THE EXTRUSION. THE BI-COMPONENT BOND SHOWED NO SIGNS OF DAMAGE OR STRAIN. 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 06-DEC-2016.   IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED.    THE 85% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 3.00 X 20 SYNERGY¿ DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE DEVICE WAS REMOVED AND 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
    842381 SYNERGY¿ CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493926220300 19402514

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR PRE-DILATED WITH IKAZUCHI 2.0