BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT? PLUS

    MDR report key: 3201844 · Received July 2, 2013

    Report

    Report Number
    2134265-2013-04609
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 4, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: A VISUAL AND MICROSCOPIC EXAMINATION FOUND THAT THE STENT HAD DETACHED FROM THE DEVICE AND WAS NOT RETURNED FOR ANALYSIS. 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. THE BALLOON WAS PARTIALLY INFLATED. 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. NO KINKS OR DAMAGE WERE NOTICED ALONG THE SHAFT OF THE DEVICE. DURING ANALYSIS, IT WAS POSSIBLE TO INFLATE THE BALLOON WITH AN INFLATION UNIT. NO ISSUES WERE NOTED DURING INFLATION, AND NO ISSUES WERE NOTED WITH THE INFLATED BALLOON. THE BALLOON WAS THEN DEFLATED WITH NO ISSUES NOTED. CONTRAST MEDIA WAS PRESENT WITHIN THE ENTIRE INFLATION 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 IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE, REMOVAL DIFFICULTIES OCCURRED. THE TARGET LESION WAS LOCATED IN THE "LITTLE" CALCIFIED AND TORTUOUS PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 3.5 6FR NON-BSC GUIDE CATHETER FOLLOWED BY A 190 CM NON-BSC GUIDE WIRE WAS ADVANCED TO THE TARGET LESION. A 2.5X12MM EMERGE BALLOON CATHETER WAS USED FOR PREDILATION AND A 2.75X12 MR PROMUS ELEMENT PLUS STENT WAS SELECTED TO TREAT THE LESION. THE BALLOON OF THE STENT DELIVERY SYSTEM WAS INITIALLY INFLATED AT 14 ATMS FOR 15 SECONDS, AND INCREASED TO 16 ATMS FOR 15 SECONDS. FOLLOWING DEFLATION, THE BALLOON WAS STUCK TO THE STENT. THE PHYSICIAN DECIDED TO INCREASE THE PRESSURE BY 4 ATMS AND DEFLATED THE DEVICE. WHILE PULLING ON THE DELIVERY BALLOON, THE GUIDE CATHETER DOVE DOWN THE VESSEL AND THE BALLOON RELEASED. THE BALLOON WAS THEN REMOVED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE, REMOVAL DIFFICULTIES OCCURRED. THE TARGET LESION WAS LOCATED IN THE "LITTLE" CALCIFIED AND TORTUOUS PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 3.5 6FR NON-BSC GUIDE CATHETER FOLLOWED BY A 190 CM NON-BSC GUIDE WIRE WAS ADVANCED TO THE TARGET LESION. A 2.5X12MM EMERGE BALLOON CATHETER WAS USED FOR PREDILATION AND A 2.75X12 MR PROMUS ELEMENT PLUS STENT WAS SELECTED TO TREAT THE LESION. THE BALLOON OF THE STENT DELIVERY SYSTEM WAS INITIALLY INFLATED AT 14 ATMS FOR 15 SECONDS, AND INCREASED TO 16 ATMS FOR 15 SECONDS. FOLLOWING DEFLATION, THE BALLOON WAS STUCK TO THE STENT. THE PHYSICIAN DECIDED TO INCREASE THE PRESSURE BY 4 ATMS AND DEFLATED THE DEVICE. WHILE PULLING ON THE DELIVERY BALLOON, THE GUIDE CATHETER DOVE DOWN THE VESSEL AND THE BALLOON RELEASED. THE BALLOON WAS THEN REMOVED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302052 PROMUS ELEMENT? PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911412270 15918976

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR GUIDE WIRE: WHISPER MS 190 CM| BALLOON CATHETER: EMERGE 2.5X12MM| GUIDE CATH: CORDIS XBLAD 3.5 6FR GUIDE