BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ¿

    MDR report key: 2850265 · Received November 29, 2012

    Report

    Report Number
    2134265-2012-07183
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Report Date
    November 6, 2012
    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 IS COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: A VISUAL AND MICROSCOPIC INSPECTION OF THE RETURNED DEVICE FOUND THAT THE STENT HAD MOVED DISTALLY ON THE BALLOON AS THE MARKERBAND IS NO LONGER VISIBLE. THE STENT ALSO HAS BUNCHED STRUTS AT THE PROXIMAL EDGE. 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. NO KINKS OR DAMAGE WERE NOTICED ALONG THE SHAFT OF THE DEVICE. SOLIDIFIED BLOOD WAS PRESENT WITHIN THE ENTIRE LENGTH OF THE GUIDE WIRE LUMEN, THEREFORE INDICATING THE DEVICE HAD BEEN USED IN VIVO. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE CLASSIFICATION OF THIS INVESTIGATION IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(4) 2012. DURING A PROCEDURE OF AN UNSPECIFIED LESION, A 2.5 X 28 MM PROMUS ELEMENT STENT WAS CHOSEN. THE DEVICE WAS REPORTED AS BEING DEFECTIVE. NO ADDITIONAL INFORMATION WAS PROVIDED. HOWEVER, DEVICE ANALYSIS REVEALED STENT DAMAGE AND THAT THE STENT HAD MOVED ON THE BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT ¿ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911328250 0014767201

    Patients

    Seq Age Sex Outcome Treatment
    1