BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT? PLUS

    MDR report key: 3120402 · Received May 20, 2013

    Report

    Report Number
    2134265-2013-03432
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Date of Event
    April 20, 2013
    Report Date
    April 22, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS RECEIVED FOR ANALYSIS. A VISUAL AND MICROSCOPIC EXAMINATION OF THE DEVICE FOUND SEVERAL SLIGHT KINKS ALONG THE WORKING LENGTH OF THE DEVICE. A VISUAL AND MICROSCOPIC EXAMINATION OF THE CRIMPED STENT FOUND NO ISSUES. 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. 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 PERCUTANEOUS CORONARY INTERVENTION, STENT DAMAGE OCCURRED. THE 99% STENOSED LESION WAS LOCATED IN THE CALCIFIED AND MODERATELY TORTUOUS PROXIMAL OF RIGHT CORONARY ARTERY. THE PHYSICIAN ATTEMPTED TO DELIVER A 3.50X24MM PROMUS ELEMENT PLUS DRUG-ELUTING STENT, BUT IT WAS UNABLE TO CROSS THE LESION. THEY USED A MICROCATHETER AND TRIED TO CROSS THE LESION, BUT NO CROSS OCCURRED. UPON REMOVAL OF THE DEVICE, THEY NOTICED THAT A PART OF THE STRUTS OF THE STENT WAS LIFTED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PERCUTANEOUS CORONARY INTERVENTION, STENT DAMAGE OCCURRED. THE 99% STENOSED LESION WAS LOCATED IN THE CALCIFIED AND MODERATELY TORTUOUS PROXIMAL OF RIGHT CORONARY ARTERY. THE PHYSICIAN ATTEMPTED TO DELIVER A 3.50X24MM PROMUS ELEMENT PLUS DRUG-ELUTING STENT, BUT IT WAS UNABLE TO CROSS THE LESION. THEY USED A MICROCATHETER AND TRIED TO CROSS THE LESION, BUT NO CROSS OCCURRED. UPON REMOVAL OF THE DEVICE, THEY NOTICED THAT A PART OF THE STRUTS OF THE STENT WAS LIFTED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222425 PROMUS ELEMENT? PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493918424350 15906375

    Patients

    Seq Age Sex Outcome Treatment
    1