BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY?

    MDR report key: 3822509 · Received May 21, 2014

    Report

    Report Number
    2134265-2014-02823
    Event Type
    Malfunction
    Date Received
    May 21, 2014
    Date of Event
    April 26, 2014
    Report Date
    April 28, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: A VISUAL EXAMINATION OF THE RETURNED DEVICE IDENTIFIED A KINK IN THE HYPOTUBE AT 12CM DISTAL TO THE STRAIN RELIEF WHICH IS CONSISTENT WITH EXCESSIVE FORCE APPLIED TO THE HYPOTUBE DURING HANDLING. AN EXAMINATION OF THE CRIMPED STENT IDENTIFIED THAT THE PROXIMAL STENT STRUT ROWS OF THE STENT WERE SECURELY CRIMPED ONTO THE BALLOON. HOWEVER THE MID TO DISTAL SECTION OF THE STENT WAS STRETCHED AND PULLED DISTALLY OVER THE TIP. THERE WAS NO EVIDENCE OF ANY DEVICE USE. NO INFLATION MEDIA WAS PRESENT INSIDE THE INFLATION LUMEN. THE STENT PROTECTOR WAS NOT RETURNED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED HANDLING DAMAGE AS THE EVENT OCCURRED PRIOR TO PATIENT CONTACT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION OF A STENTING PROCEDURE, STENT DAMAGE OCCURRED. STENT DAMAGE WAS NOTED ON THE DISTAL TIP OF A 2.5X20MM SYNERGY WHILE IT WAS BEING REMOVED FROM THE CARRIER TUBE DURING PREPARATION. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PROCEDURE AS COMPLETED WITH ANOTHER SAME DEVICE. THE PATIENT'S STATUS IS STABLE. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO AN APPROVED U.S. DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION OF A STENTING PROCEDURE, STENT DAMAGE OCCURRED. STENT DAMAGE WAS NOTED ON THE DISTAL TIP OF A 2.5X20MM SYNERGY WHILE IT WAS BEING REMOVED FROM THE CARRIER TUBE DURING PREPARATION. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PROCEDURE AS COMPLETED WITH ANOTHER SAME DEVICE. THE PATIENT'S STATUS IS STABLE. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO AN APPROVED US DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303742 SYNERGY? CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493926220250 16437820

    Patients

    Seq Age Sex Outcome Treatment
    1