BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ¿

    MDR report key: 2212703 · Received August 16, 2011

    Report

    Report Number
    2134265-2011-03430
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    July 11, 2011
    Report Date
    July 25, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: A VISUAL AND MICROSCOPIC EXAMINATION OF THE DEVICE FOUND STENT DAMAGE. STENT STRUTS FROM THE MIDDLE OF THE STENT TO THE THIRD MOST PROXIMAL ROW WERE STRETCHED AND DAMAGED. THIS TYPE OF DAMAGE IS CONSISTENT WITH THE STENT MEETING RESISTANCE UPON ADVANCEMENT AND/OR WITHDRAWAL. THE TIP AND BALLOON 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 HYPOTUBE WAS KINKED ALONG ITS ENTIRE LENGTH. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED TO THE DELIVERY SYSTEM. MANDREL RESISTANCE WAS ENCOUNTERED, POSSIBLY DUE TO THE PRESENCE OF SOLIDIFIED BLOOD WITHIN THE GUIDEWIRE LUMEN, THEREFORE INDICATING THE DEVICE HAD BEEN USED IN VIVO. 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

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE THE STENT MOVED ON THE BALLOON AND STENT DAMAGE OCCURRED. ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE 70% STENOSED, 3.5X20MM ECCENTRIC AND DE NOVO TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED RIGHT CORONARY ARTERY (RCA). A 3.50X24MM PROMUS ELEMENT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE TARGET LESION; HOWEVER, BEFORE THE STENT WAS DEPLOYED IT WAS NOTED THAT THE STENT HAD MOVED ON THE BALLOON AND THERE WAS AN APPEARANCE OF "WRINKLING OF THE MESH". THE DEVICE WAS REMOVED AS A SYSTEM WITH THE GUIDE CATHETER AND GUIDE WIRE. THE SAME GUIDE CATHETER AND GUIDE WIRE WERE RE-ADVANCED TO THE LESION AND ANOTHER PROMUS ELEMENT STENT WAS SUCCESSFULLY DEPLOYED IN THE LESION. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CURRENT CONDITION 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 THE STENT MOVED ON THE BALLOON AND STENT DAMAGE OCCURRED. ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE 70% STENOSED, 3.5X20MM ECCENTRIC AND DE NOVO TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED RIGHT CORONARY ARTERY (RCA). A 3.50X24MM PROMUS ELEMENT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE TARGET LESION; HOWEVER, BEFORE THE STENT WAS DEPLOYED IT WAS NOTED THAT THE STENT HAD MOVED ON THE BALLOON AND THERE WAS AN APPEARANCE OF ¿WRINKLING OF THE MESH¿. THE DEVICE WAS REMOVED AS A SYSTEM WITH THE GUIDE CATHETER AND GUIDE WIRE. THE SAME GUIDE CATHETER AND GUIDE WIRE WERE RE-ADVANCED TO THE LESION AND ANOTHER PROMUS ELEMENT STENT WAS SUCCESSFULLY DEPLOYED IN THE LESION. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT¿S CURRENT CONDITION 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 H7493911324350 14223341

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR