BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ?

    MDR report key: 3103263 · Received May 9, 2013

    Report

    Report Number
    2134265-2013-03021
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 12, 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 IS A COMBINATION PRODUCT. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: THE COMPLAINT DEVICE WAS RECEIVED FOR ANALYSIS. A VISUAL AND MICROSCOPIC EXAMINATION OF THE DEVICE NOTED PROXIMAL STENT DAMAGE. STRUTS AT THE PROXIMAL EDGE OF THE STENT WERE BUNCHED AND MISALIGNED. NO KINKS OR DAMAGE WERE NOTICED ALONG THE SHAFT OF THE DEVICE. THE BALLOON AND TIP SECTIONS OF THE DEVICE WERE VISUALLY AND MICROSCOPICALLY EXAMINED AND NO ISSUES WERE NOTED 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, STENT DAMAGE OCCURRED. THE 90% STENOSED AND SEVERELY CALCIFIED LESION WAS LOCATED IN THE SEVERELY TORTUOUS MIDDLE OF LEFT ANTERIOR DESCENDING ARTERY. A 3.00X20MM PROMUS ELEMENT DRUG-ELUTING STENT WAS USED TO CROSS THE LESION, BUT NO CROSS OCCURRED. WHEN THE PHYSICIAN REMOVED THE DEVICE, THEY NOTICED THAT A PART 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 A PERCUTANEOUS CORONARY INTERVENTION, STENT DAMAGE OCCURRED. THE 90% STENOSED AND SEVERELY CALCIFIED LESION WAS LOCATED IN THE SEVERELY TORTUOUS MIDDLE OF LEFT ANTERIOR DESCENDING ARTERY. A 3.00X20MM PROMUS ELEMENT DRUG-ELUTING STENT WAS USED TO CROSS THE LESION, BUT NO CROSS OCCURRED. WHEN THE PHYSICIAN REMOVED THE DEVICE, THEY NOTICED THAT A PART 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
    202876 PROMUS ELEMENT ? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911320300 15399286

    Patients

    Seq Age Sex Outcome Treatment
    1