BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ?

    MDR report key: 3955021 · Received July 24, 2014

    Report

    Report Number
    2134265-2014-04369
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    June 30, 2014
    Report Date
    June 30, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE STENT DELIVERY SYSTEM (SDS); ASSOCIATED WITH THE FINISHED GOODS BATCH WAS RETURNED FOR ANALYSIS. A VISUAL EXAMINATION OF THE CRIMPED STENT FOUND STENT STRUTS ON THE PROXIMAL END OF THE CRIMPED STENT WERE DISTORTED AND LIFTED UPWARDS FROM THE STENT PROFILE. IT IS LIKELY THE CRIMPED STENT MAY HAVE ENCOUNTERED RESISTANCE & SUBSEQUENT DAMAGE DURING ADVANCEMENT ATTEMPTS. 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 HYPOTUBE PROFILE. A VISUAL AND TACTILE EXAMINATION FOUND NO ISSUES WITH THE SHAFT POLYMER EXTRUSION 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).

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE IS A COMBINATION PRODUCT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 2.25X28MM PROMUS ELEMENT DRUG ELUTING STENT WAS SELECTED FOR USE AND ADVANCED TO TREAT AN UNSPECIFIED TARGET LESION. HOWEVER, THE STENT COULD NOT CROSS THE LESION AND UPON DEVICE WITHDRAWAL, THE PHYSICIAN NOTICED THAT THE STENT WAS DEFORMED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 2.25X28MM PROMUS ELEMENT ¿ DRUG ELUTING STENT WAS SELECTED FOR USE AND ADVANCED TO TREAT AN UNSPECIFIED TARGET LESION. HOWEVER, THE STENT COULD NOT CROSS THE LESION AND UPON DEVICE WITHDRAWAL, THE PHYSICIAN NOTICED THAT THE STENT WAS DEFORMED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434689 PROMUS ELEMENT ? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493911328220 16588142

    Patients

    Seq Age Sex Outcome Treatment
    1