BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT¿ PLUS

    MDR report key: 2822612 · Received November 7, 2012

    Report

    Report Number
    2134265-2012-07042
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Date of Event
    October 19, 2012
    Report Date
    October 19, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPDATED: DEVICE EVALUATED BY MFR., EVAL SUMMARY ATTACHED, METHOD CODES, RESULTS CODES, CONCLUSION CODES. DEVICE EVALUATED BY MANUFACTURER - A VISUAL AND MICROSCOPIC EXAMINATION OF THE DEVICE FOUND THE DEVICE WAS RETURNED TO THE COMPLAINT INVESTIGATION SITE WITH THE STENT DETACHED FROM THE BALLOON. THE BALLOON WAS FOUND TO HAVE THE STENT IMPRESSIONS ON IT AND PILLOWING OF THE BALLOON INDICATING THAT THE STENT WAS CRIMPED PER PROCESS IN THE CORRECT LOCATION DURING MANUFACTURING. THE STENT WAS NOT RETURNED. THE DEVICE WAS RETURNED WITH THE GUIDEWIRE ATTACHED. THIS WAS UNABLE TO BE REMOVED DUE TO THE PRESENCE OF A LARGE AMOUNT OF CONTRAST MEDIA. NO KINKS OR DAMAGE WAS NOTED ALONG THE SHAFT OF THE DEVICE. THE BALLOON AND TIP 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 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).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, CATHETER ENTRAPMENT OCCURRED. THE 90% STENOSED, 2.3-2.75X28MM LESION BEING TREATED CONTAINED A GREATER THAN 45 DEGREE BEND AND WAS LOCATED IN THE SEVERELY TORTUOUS, MODERATELY CALCIFIED MID-DISTAL LEFTY CIRCUMFLEX (LCX) ARTERY. THE LESION WAS PREDILATED WITH AN UNKNOWN BALLOON, INFLATED TO 12ATM. AFTER THE DEPLOYMENT OF THE 2.25X16MM PROMUS ELEMENT PLUS STENT, THE PHYSICIAN ATTEMPTED TO REMOVE THE STENT DELIVERY SYSTEM (SDS) FROM THE PATIENT. HOWEVER, THE PHYSICIAN WAS UNABLE TO REMOVE THE SDS FROM THE UNKNOWN GUIDE WIRE. THE UNKNOWN GUIDE WIRE AND SDS WERE REMOVED TOGETHER AS A UNIT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, CATHETER ENTRAPMENT OCCURRED. THE 90% STENOSED, 2.3-2.75 X 28 MM LESION BEING TREATED CONTAINED A GREATER THAN 45 DEGREE BEND AND WAS LOCATED IN THE SEVERELY TORTUOUS, MODERATELY CALCIFIED MID-DISTAL LEFTY CIRCUMFLEX (LCX) ARTERY. THE LESION WAS PREDILATED WITH AN UNKNOWN BALLOON, INFLATED TO 12 ATM. AFTER THE DEPLOYMENT OF THE 2.25 X 16 MM PROMUS ELEMENT PLUS STENT, THE PHYSICIAN ATTEMPTED TO REMOVE THE STENT DELIVERY SYSTEM (SDS) FROM THE PATIENT. HOWEVER, THE PHYSICIAN WAS UNABLE TO REMOVE THE SDS FROM THE UNKNOWN GUIDE WIRE. THE UNKNOWN GUIDE WIRE AND SDS WERE REMOVED TOGETHER AS A UNIT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT¿ PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493918416220 15235279

    Patients

    Seq Age Sex Outcome Treatment
    1