BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ¿

    MDR report key: 2190516 · Received August 4, 2011

    Report

    Report Number
    2134265-2011-03241
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    June 27, 2011
    Report Date
    July 18, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: A VISUAL AND MICROSCOPIC EXAMINATION FOUND THAT THE HYPOTUBE HAD BROKEN 147MM DISTAL FROM THE CATHETER'S STRAIN RELIEF. THERE WERE KINKS IDENTIFIED ALONG THE ENTIRE LENGTH OF THE HYPOTUBE. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED TO THE DELIVERY SYSTEM. INNER LUMEN KINKS WERE ALSO IDENTIFIED. THIS TYPE OF DAMAGE COULD BE CAUSED BY EXCESSIVE FORCE BEING APPLIED DURING GUIDEWIRE REMOVAL. THE CRIMPED STENT, BALLOON AND TIP SECTIONS OF THE DEVICE WERE 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. SOLIDIFIED BLOOD WAS PRESENT ON THE BALLOON, THEREFORE INDICATING THE DEVICE HAD BEEN USED IN VIVO. A 0.015 INCH PRODUCT MANDREL WAS INSERTED THROUGH THE GUIDEWIRE 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 CLASSIFICATION OF THIS INVESTIGATION IS USER RELATED. THE INDICATIONS FOR USE SECTION OF THE DFU FOR THIS DEVICE STATES "THE PROMUS ELEMENT" EVEROLIMUS ELUTING CORONARY STENT SYSTEM IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE. HOWEVER, THIS DEVICE WAS USED TO TREAT A LESION IN A GRAFT IN THE RIGHT FEMORAL ARTERY. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, SHAFT FRACTURE OCCURRED. THE LESION BEING TREATED WAS LOCATED IN THE RIGHT FEMORAL GRAFT. WHILE ADVANCING THE 3.0X28MM PROMUS ELEMENT STENT DELIVERY SYSTEM TO THE PROXIMAL END OF THE SHAFT FRACTURED OUTSIDE OF THE PATIENT. THE DEVICE WAS SUCCESSFULLY REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S 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 DURING A STENTING TREATMENT PROCEDURE, SHAFT FRACTURE OCCURRED. THE LESION BEING TREATED WAS LOCATED IN THE RIGHT FEMORAL GRAFT. WHILE ADVANCING THE 3.0X28MM PROMUS ELEMENT STENT DELIVERY SYSTEM TO THE PROXIMAL END OF THE SHAFT FRACTURED OUTSIDE OF THE PATIENT. THE DEVICE WAS SUCCESSFULLY REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND 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
    1 PROMUS ELEMENT ¿ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911328300 14013884

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR