BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2160159 · Received July 13, 2011

    Report

    Report Number
    2134265-2011-02864
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    June 14, 2011
    Report Date
    June 28, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. PATIENT AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER - A VISUAL AND MICROSCOPIC EXAMINATION OF THE DEVICE IDENTIFIED PROXIMAL STENT DAMAGE. STRUTS ON THE 1ST ROW FROM THE PROXIMAL END OF THE STENT WERE RAISED DISTALLY. NO ISSUES WERE NOTED WITH THE BALLOON AND TIP SECTIONS OF THE DEVICE THAT COULD HAVE POTENTIALLY CONTRIBUTED TO THE COMPLAINT INCIDENT. THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO POSITIVE PRESSURE. A KINK WAS IDENTIFIED IN THE MIDSHAFT, 12MM FROM THE PORT. KINKS WERE IDENTIFIED ALONG THE ENTIRE LENGTH OF THE HYPOTUBE. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED TO THE DELIVERY SYSTEM. A MANDREL WAS INSERTED THROUGH THE LUMEN WITH NO RESTRICTIONS NOTED. SOLIDIFIED CONTRAST MEDIA WAS PRESENT WITHIN THE ENTIRE LENGTH OF THE INFLATION LUMEN, THEREFORE INDICATING THE DEVICE HAD BEEN PREPPED FOR USE. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI), STENT DAMAGE OCCURRED. THE TARGET LESION WAS UNKNOWN. THE PHYSICIAN LOADED THE 3.50X12MM PROMUS ELEMENT STENT ONTO THE GUIDEWIRE, ONCE IN THE PATENT STENT DAMAGE WAS VISUALIZED UNDER FLUOROSCOPY. THE PHYSICIAN WAS UNABLE TO PULL THE STENT DELIVERY SYSTEM BACK THROUGH THE GUIDE CATHETER; SO THE SYSTEM WAS PULLED OUT OF THE PATENT AS A UNIT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT STATUS IS FINE. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO AN APPROVED US DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI), STENT DAMAGE OCCURRED. THE TARGET LESION WAS UNKNOWN. THE PHYSICIAN LOADED THE 3.50X12MM PROMUS ELEMENT STENT ONTO THE GUIDEWIRE, ONCE IN THE PATENT STENT DAMAGE WAS VISUALIZED UNDER FLUOROSCOPY. THE PHYSICIAN WAS UNABLE TO PULL THE STENT DELIVERY SYSTEM BACK THROUGH THE GUIDE CATHETER; SO THE SYSTEM WAS PULLED OUT OF THE PATENT AS A UNIT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT STATUS IS FINE. 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 H7493911312350 13615600

    Patients

    Seq Age Sex Outcome Treatment
    1