BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2142273 · Received June 28, 2011

    Report

    Report Number
    2134265-2011-02444
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    April 1, 2011
    Report Date
    June 1, 2011
    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 A COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: A VISUAL AND MICROSCOPIC EXAMINATION IDENTIFIED A BREAK IN THE HYPOTUBE 230MM DISTAL TO THE CATHETER STRAIN RELIEF. THE LENGTH OF THE TAXUS LIBERTE STENT DELIVERY SYSTEM (SDS) FROM THE PROXIMAL BODY CONE/BODY TRANSITION OF THE BALLOON TO DISTAL END OF THE CATHETER STRAIN RELIEF MEETS SPECIFICATION. THE LENGTH OF THIS DEVICE FROM THE PROXIMAL BODY/CONE TRANSITION TO THE BREAK POINT IS 119CM. THE HYPOTUBE WAS KINKED ALONG IT'S ENTIRE LENGTH. SOLIDIFIED BLOOD WAS PRESENT WITHIN THE ENTIRE LENGTH OF THE INFLATION LUMEN, THEREFORE INDICATING THE DEVICE HAD BEEN USED IN VIVO. THE TIP OF THE DEVICE WAS SLIGHTLY FLARED. THE BALLOON AND STENT SECTIONS OF THE DEVICE WERE VISUALLY AND MICROSCOPICALLY EXAMINED AND NO ISSUES WERE NOTED WITH THEIR PROFILES THAT COULD HAVE POTENTIALLY CONTRIBUTED TO THE COMPLAINT INCIDENT. THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO POSITIVE PRESSURE. 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

    SAME PATIENT AS 2134265-2011-02441. REPORTABLE BASED ON ANALYSIS COMPLETED(B)(6) 2011. IT WAS REPORTED THAT DURING A CORONARY ARTERY STENTING TREATMENT PROCEDURE THERE WAS DIFFICULTY CROSSING THE LESION. THE 85% STENOSED LESION BEING TREATED WAS LOCATED IN THE, MILDLY TORTUOUS AND SEVERELY CALCIFIED RIGHT CORONARY ARTERY. PRE-DILATATION WAS PERFORMED USING A 2.0X20MM SEMI-COMPLIANT BALLOON. THE 2.25X28MM PROMUS ELEMENT STENT FAILED TO CROSS THE LESION. THERE WERE NO REPORTED COMPLICATIONS AND THE PATIENT CONDITION IS STABLE. HOWEVER, DEVICE ANALYSIS FOUND A SHAFT FRACTURE. 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
    1 PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911328220 13803800

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR