BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ?

    MDR report key: 3053003 · Received April 11, 2013

    Report

    Report Number
    2134265-2013-02139
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 10, 2013
    Report Date
    March 14, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: 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 RETURNED FOR ANALYSIS AND WAS FOUND TO BE DAMAGED THROUGHOUT. NO KINKS WERE IDENTIFIED ALONG THE ENTIRE LENGTH OF THE HYPOTUBE. THE BALLOON AND TIP SECTIONS OF THE DEVICE WERE VISUALLY AND MICROSCOPICALLY EXAMINED AND NO ISSUES WERE NOTED WITH ITS PROFILE. 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

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PREPARATION FOR A STENTING TREATMENT PROCEDURE, A 2.5X12MM PROMUS ELEMENT STENT DISLODGED FROM THE BALLOON WHILE TAKING THE DEVICE OUT FROM THE HOOP. WHEN THE STAFF CHECKED AROUND, THEY FOUND THE UNINFLATED STENT ON THE TRAY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PAITENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PREPARATION FOR A STENTING TREATMENT PROCEDURE, A 2.5X12MM PROMUS ELEMENT STENT DISLODGED FROM THE BALLOON WHILE TAKING THE DEVICE OUT FROM THE HOOP. WHEN THE STAFF CHECKED AROUND, THEY FOUND THE UNINFLATED STENT ON THE TRAY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156561 PROMUS ELEMENT ? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911312250 15127560

    Patients

    Seq Age Sex Outcome Treatment
    1