BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2103169 · Received May 25, 2011

    Report

    Report Number
    2134265-2011-01914
    Event Type
    Injury
    Date Received
    May 25, 2011
    Date of Event
    April 29, 2011
    Report Date
    April 29, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: A VISUAL AND MICROSCOPIC EXAMINATION OF THE DEVICE REVEALED THAT THE STENT WAS DEPLOYED FROM THE STENT DELIVERY SYSTEM (SDS) AND WAS NOT RETURNED. THE BALLOON WAS RETURNED FULLY DEFLATED. DURING ANALYSIS, THE BALLOON WAS INFLATED AND DEFLATED AS PER THE DFU. THE LUMEN WAS KINKED AT 49 MM DISTAL TO THE PORT. THE HYPOTUBE WAS KINKED ALONG ITS ENTIRE LENGTH. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED TO THE DELIVERY SYSTEM. THE TIP SECTION OF THE DEVICE WAS VISUALLY AND MICROSCOPICALLY EXAMINED AND NO ISSUES WERE NOTED WITH ITS PROFILE THAT COULD HAVE POTENTIALLY CONTRIBUTED TO THE COMPLAINT INCIDENT. A 0.015 INCH PRODUCT MANDREL WAS INSERTED THROUGH THE LUMEN WITH SOME RESISTANCE NOTED. CONTRAST MEDIA WAS PRESENT WITHIN THE BALLOON AND THE ENTIRE LENGTH OF THE LUMEN, THEREFORE INDICATING THAT THE DEVICE WAS PREPPED FOR USE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE OF THIS INVESTIGATION IS USER/USE ERROR BECAUSE THE DIRECTIONS FOR USE STATE "INFLATE THE DELIVERY SYSTEM EXPANDING THE STENT TO A MINIMUM PRESSURE OF 12 ATM. MAINTAIN INFLATION PRESSURE FOR 15¿30 SECONDS FOR FULL EXPANSION OF THE STENT". HOWEVER, THE COMPLAINT STATES THAT THE BALLOON OF THIS DEVICE WAS INFLATED TO A PRESSURE OF 8 ATM FOR 15 SECONDS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, WITHDRAWAL RESISTANCE OCCURRED. THE 75% STENOSED, DE NOVO, ECCENTRIC, 10X3.1MM TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING (LAD) ARTERY. AFTER THE LESION WAS PREDILATED AND THE STENOSIS WAS REDUCED TO 30%, A 3.5X12MM PROMUS ELEMENT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION. THE STENT WAS SUCCESSFULLY DEPLOYED AT 8 ATMS/15SEC AND WAS FULLY APPOSED. THE BALLOON WAS COMPLETELY DEFLATED AND UPON REMOVAL FROM THE STENT THERE WAS SIGNIFICANT BALLOON WITHDRAWAL RESISTANCE. THE PHYSICIAN PULLED NEGATIVE, PUSHED WITH FORCE AND WAS ABLE TO REMOVE THE DELIVERY SYSTEM WITHOUT AFFECTING THE STENT. ONCE OUTSIDE THE PATIENT, IT WAS NOTED THAT THE BALLOON WAS DAMAGED AND "COLLAPSED ON THE DISTAL PART". THE PATIENT EXPERIENCED HYPOTENSION AND WAS ADMINISTERED DOPAMINE. FOUR ADDITIONAL STENTS WERE PLACED IN THE FOLLOWING LOCATIONS DURING THE PROCEDURE: A 3X15MM NON-BSC STENT IN THE DISTAL RIGHT CORONARY ARTERY (RCA), A 2.25X14MM NON-BSC STENT IN THE POSTERIOR DESCENDING, A 2.5X14MM NON-BSC MID LAD, A 4X24MM PROMUS ELEMENT STENT IN THE LEFT MAIN (LM) TO LAD. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS DISCHARGED ONE WEEK LATER IN STABLE CONDITION. 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, WITHDRAWAL RESISTANCE OCCURRED. THE 75% STENOSED, DE NOVO, ECCENTRIC, 10X3.1MM TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING (LAD) ARTERY. AFTER THE LESION WAS PREDILATED AND THE STENOSIS WAS REDUCED TO 30%, A 3.5X12MM PROMUS ELEMENT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION. THE STENT WAS SUCCESSFULLY DEPLOYED AT 8 ATMS/15SEC AND WAS FULLY APPOSED. THE BALLOON WAS COMPLETELY DEFLATED AND UPON REMOVAL FROM THE STENT THERE WAS SIGNIFICANT BALLOON WITHDRAWAL RESISTANCE. THE PHYSICIAN PULLED NEGATIVE, PUSHED WITH FORCE AND WAS ABLE TO REMOVE THE DELIVERY SYSTEM WITHOUT AFFECTING THE STENT. ONCE OUTSIDE THE PATIENT, IT WAS NOTED THAT THE BALLOON WAS DAMAGED AND "COLLAPSED ON THE DISTAL PART". THE PATIENT EXPERIENCED HYPOTENSION AND WAS ADMINISTERED DOPAMINE. FOUR ADDITIONAL STENTS WERE PLACED IN THE FOLLOWING LOCATIONS DURING THE PROCEDURE: A 3X15MM NON-BSC STENT IN THE DISTAL RIGHT CORONARY ARTERY (RCA), A 2.25X14MM NON-BSC STENT IN THE POSTERIOR DESCENDING, A 2.5X14MM NON-BSC MID LAD, A 4X24MM PROMUS ELEMENT STENT IN THE LEFT MAIN (LM) TO LAD. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS DISCHARGED ONE WEEK LATER IN STABLE CONDITION. 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 13945641

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention BMW GUIDEWIRE.| EBU 4 GUIDE CATHETER