BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2183064 · Received July 28, 2011

    Report

    Report Number
    2134265-2011-03210
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    June 14, 2011
    Report Date
    July 15, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER - A VISUAL AND MICROSCOPIC EXAMINATION OF THE DEVICE FOUND THE DEVICE WAS RETURNED TO THE COMPLAINT INVESTIGATION SITE WITH DISTAL AND PROXIMAL STENT DAMAGE. STRUT ROWS AT THE DISTAL AND PROXIMAL ENDS OF THE STENT WERE RAISED FROM THE BALLOON AND MISALIGNED. THE DISTAL AND PROXIMAL ENDS OF THE BALLOON APPEARED TO BE PARTIALLY INFLATED. THE TIP SECTION OF THE DEVICE WAS VISUALLY AND MICROSCOPICALLY EXAMINED AND NO ISSUES WERE NOTED WITH ITS PROFILES THAT COULD HAVE POTENTIALLY CONTRIBUTED TO THE COMPLAINT INCIDENT. THE HYPOTUBE WAS KINKED ALONG ITS ENTIRE LENGTH. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED TO THE DELIVERY SYSTEM. CONTRAST MEDIA WAS PRESENT WITHIN THE INFLATION LUMEN, THEREFORE INDICATING THAT THE DEVICE WAS PREPPED FOR USE. A MANDREL WAS INSERTED THROUGH THE LUMEN WITH NO RESTRICTIONS NOTED. 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 PRIOR TO A PERCUTANEOUS CORONARY INTERVENTION, STENT DAMAGE OCCURRED. THE TARGET LESION TO BE TREATED WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD). AS THE 2.75X28MM PROMUS ELEMENT STENT WAS INSPECTED PRIOR TO USE THE PHYSICIAN NOTED THE STENT APPEARED DISRUPTED AND THERE WERE RAISED STENT STRUTS. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER 2.75X28MM PROMUS ELEMENT STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT STATUS IS STABLE. 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 PRIOR TO A PERCUTANEOUS CORONARY INTERVENTION, STENT DAMAGE OCCURRED. THE TARGET LESION TO BE TREATED WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD). AS THE 2.75X28MM PROMUS ELEMENT STENT WAS INSPECTED PRIOR TO USE THE PHYSICIAN NOTED THE STENT APPEARED DISRUPTED AND THERE WERE RAISED STENT STRUTS. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER 2.75X28MM PROMUS ELEMENT STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT 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
    1 PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911328270 14309334

    Patients

    Seq Age Sex Outcome Treatment
    1