BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2160071 · Received July 13, 2011

    Report

    Report Number
    2134265-2011-02824
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    June 22, 2011
    Report Date
    June 23, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BD
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPDATED: DEVICE AVAIL. FOR EVAL, RETURNED TO MFR. ON, DEVICE RETURNED TO MFR, DEVICE EVALUATED BY MFR, EVAL SUMMARY ATTACHED, METHOD, RESULTS AND CONCLUSION. A VISUAL AND MICROSCOPIC EXAMINATION OF THE DEVICE REVEALED STENT DAMAGE. THE STENT WAS MISALIGNED TOWARDS THE MIDDLE OF THE STENT AND STRETCHED ACROSS THE PROXIMAL MARKERBAND DISTAL AND MIDDLE SECTIONS OF THE STENT WERE SQUASHED. THE PROXIMAL END OF THE STENT WAS RAISED AND MISALIGNED. 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. A 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 WAS DETERMINED TO BE USER ERROR. THIS DEVICE COULD NOT CROSS THE LESION AT THE MIDDLE SECTION OF THE RCA AND RESISTANCE WAS ENCOUNTERED UPON ADVANCEMENT. THE PHYSICIAN ATTEMPTED TO FORCE THE DEVICE TO CROSS THE LESION. THE DFU STATES THAT "IF UNUSUAL RESISTANCE IS FELT AT ANY TIME DURING LESION ACCESS BEFORE STENT IMPLANTATION, THE STENT SYSTEM AND THE GUIDE CATHETER SHOULD BE REMOVED AS A SINGLE UNIT. USE OF EXCESSIVE FORCE MAY RESULT IN STENT DAMAGE OR STENT DISLODGMENT FROM THE BALLOON". THE PHYSICIAN REPORTED THAT DUE TO THE DAMAGE TO THE STENT, IT WOULD NOT ENTER THE GUIDE CATHETER UPON WITHDRAWAL. THE DFU ALSO STATES, "DO NOT ATTEMPT TO PULL AN UNEXPANDED STENT BACK INTO THE GUIDE CATHETER, AS STENT OR COATING DAMAGE OR STENT DISLODGMENT FROM THE BALLOON MAY OCCUR." (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: 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, STENT DAMAGE OCCURRED. ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY. THE 90-95% STENOSED, CONCENTRIC AND DE NOVO 34-36MMX3.5MM LONG TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND NON-CALCIFIED PROXIMAL TO MID RIGHT CORONARY ARTERY (RCA). THE LESION WAS PREDILATED WITH A 2.0X15MM BALLOON AFTER WHICH THE RESIDUAL STENOSIS WAS 60%. NEXT, A 3.5X38MM PROMUS ELEMENT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED BUT COULD NOT CROSS THE LESION. THE PHYSICIAN APPLIED FORCE TO THE DEVICE AND THE STENT HIT THE TIP OF THE GUIDE CATHETER CAUSING THE DISTAL END OF THE STENT TO BECOME DAMAGED. THE PROXIMAL END OF THE STENT WAS UNWRAPPED AND IT WAS NOT POSSIBLE TO PULL THE STENT BACK INTO THE GUIDE CATHETER. THEREFORE, THE SDS, GUIDE CATHETER AND GUIDE WIRE WERE REMOVED TOGETHER UNDER FLUOROSCOPIC GUIDANCE. NEXT, A NEW GUIDE CATHETER ENGAGED THE VESSEL. USING TWO GUIDE WIRES, THE PHYSICIAN ADVANCED AND DEPLOYED A 3.5X38MM NON-BSC STENT. THERE WERE NO PATIENT COMPLICATIONS 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, STENT DAMAGE OCCURRED. ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY. THE 90-95% STENOSED, CONCENTRIC AND DE NOVO 34-36MMX3.5MM LONG TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND NON-CALCIFIED PROXIMAL TO MID RIGHT CORONARY ARTERY (RCA). THE LESION WAS PREDILATED WITH A 2.0X15MM BALLOON AFTER WHICH THE RESIDUAL STENOSIS WAS 60%. NEXT, A 3.5X38MM PROMUS ELEMENT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED BUT COULD NOT CROSS THE LESION. THE PHYSICIAN APPLIED FORCE TO THE DEVICE AND THE STENT HIT THE TIP OF THE GUIDECATHETER CAUSING THE DISTAL END OF THE STENT TO BECOME DAMAGED. THE PROXIMAL END OF THE STENT WAS UNWRAPPED AND IT WAS NOT POSSIBLE TO PULL THE STENT BACK INTO THE GUIDE CATHETER. THEREFORE, THE SDS, GUIDE CATHETER AND GUIDE WIRE WERE REMOVED TOGETHER UNDER FLUOROSCOPIC GUIDANCE. NEXT, A NEW GUIDE CATHETER ENGAGED THE VESSEL. USING TWO GUIDE WIRES, THE PHYSICIAN ADVANCED AND DEPLOYED A 3.5X38MM NON-BSC STENT. THERE WERE NO PATIENT COMPLICATIONS 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 EVEROLIMUS-ELUTING CORONARY STENT SYSTEM STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911338350 0014189450

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR