BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT¿ PLUS

    MDR report key: 2833814 · Received November 15, 2012

    Report

    Report Number
    2134265-2012-06945
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    October 17, 2012
    Report Date
    October 19, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 ALSO RETURNED SEVERELY STRETCHED AND DAMAGED. KINKS WERE ALSO 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. SOLIDIFIED CONTRAST MEDIA WAS PRESENT WITHIN THE ENTIRE LENGTH OF THE INFLATION LUMEN, THEREFORE INDICATING THE DEVICE HAD BEEN 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 STENTING TREATMENT PROCEDURE, A STENT EXPLANT OCCURRED. THE LESION BEING TREATED WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). THE PHYSICIAN IMPLANTED A 2.74X24MM PROMUS ELEMENT PLUS STENT. THE STENT DELIVERY SYSTEM WAS REMOVED. HOWEVER, WHEN THE PHYSICIAN REMOVED THE 2 NON-BSC GUIDE WIRES THE STENT WAS EXPLANTED AND REMOVED WITH THE GUIDE WIRES. TWO NON-BSC STENTS WERE IMPLANTED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A STENT EXPLANT OCCURRED. THE LESION BEING TREATED WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). THE PHYSICIAN IMPLANTED A 2.74X24MM PROMUS ELEMENT PLUS STENT. THE STENT DELIVERY SYSTEM WAS REMOVED. HOWEVER, WHEN THE PHYSICIAN REMOVED THE 2 NON-BSC GUIDE WIRES THE STENT WAS EXPLANTED AND REMOVED WITH THE GUIDE WIRES. TWO NON-BSC STENTS WERE IMPLANTED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT¿ PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911424270 14860620

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention BMW GUIDE WIRE X2| HOCKEYSTICK GUIDE CATHETER