BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS PREMIER?

    MDR report key: 3901509 · Received June 30, 2014

    Report

    Report Number
    2134265-2014-03701
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    May 29, 2014
    Report Date
    June 3, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.; A VISUAL EXAMINATION OF THE CRIMPED STENT FOUND STENT STRUTS ON THE PROXIMAL END OF THE CRIMPED STENT WERE DISTORTED, BUNCHED AND LIFTED UPWARDS FROM THE STENT PROFILE. BASED ON THE ANALYSIS IT MAY BE POSSIBLE THAT THE DAMAGE TO THE PROXIMAL END OF THE STENT OCCURRED DURING THE PREPARATION AND HANDLING OF THE DEVICE WHILE REMOVING THE STENT PROTECTOR HOWEVER THIS CANNOT BE CONFIRMED. THE BUMPER TIP OF THE DEVICE SHOWED NO SIGNS OF DAMAGE. THE BALLOON CONES PROFILES WERE REVIEWED AND NO ISSUES WERE NOTED WITH THE OVERALL BALLOON PROFILE. THE BALLOON WINGS WERE TIGHTLY WRAPPED AND EVENLY FOLDED AND WERE NOT SUBJECTED TO POSITIVE PRESSURE. A VISUAL AND TACTILE EXAMINATION FOUND NO ISSUES WITH THE PROFILE. A VISUAL AND TACTILE EXAMINATION FOUND NO ISSUES WITH THE PROFILE. 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING UNPACKING, STENT DAMAGE OCCURRED. A 3.00X38MM PROMUS PREMIER STENT WAS SELECTED TO TREAT THE LESION. DURING UNPACKING THE PHYSICIAN NOTICED THAT THERE WERE VISIBLE RAISED UP STENTS ON THE PROXIMAL END AFTER IT WAS TAKEN OUT OF THE HOOP, HE FELT IT WAS PHYSICALLY DAMAGED AND HE NEVER USE IT TO HIS PATIENT. HE GOT ANOTHER DEVICE OF THE SAME SIZE AND USED WITHOUT ISSUES TO HIS PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING UNPACKING, STENT DAMAGE OCCURRED. A 3.00X38MM PROMUS PREMIER STENT WAS SELECTED TO TREAT THE LESION. DURING UNPACKING THE PHYSICIAN NOTICED THAT THERE WERE VISIBLE RAISED UP STENTS ON THE PROXIMAL END AFTER IT WAS TAKEN OUT OF THE HOOP, HE FELT IT WAS PHYSICALLY DAMAGED AND HE NEVER USE IT TO HIS PATIENT. HE GOT ANOTHER DEVICE OF THE SAME SIZE AND USED WITHOUT ISSUES TO HIS PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379487 PROMUS PREMIER? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493952838300 16689344

    Patients

    Seq Age Sex Outcome Treatment
    1