BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2003965 · Received March 1, 2011

    Report

    Report Number
    2134265-2011-00369
    Event Type
    Malfunction
    Date Received
    March 1, 2011
    Date of Event
    November 29, 2010
    Report Date
    February 2, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: A VISUAL AND MICROSCOPIC EXAMINATION OF THE DEVICE REVEALED THAT A PORTION OF THE TIP WAS DETACHED FROM THE DEVICE. CONFIRMATION WAS RECEIVED FROM THE FACILITY THAT THE DETACHED PORTION OF THE TIP DOES NOT REMAIN IN THE PATIENT. FURTHER EXAMINATION OF THE RETURNED SECTION OF THE TIP REVEALED THAT IT WAS SLIGHTLY FLARED. SOLIDIFIED CONTRAST MEDIA WAS PRESENT WITHIN THE ENTIRE LENGTH OF THE INFLATION LUMEN, THEREFORE INDICATING THE DEVICE HAD BEEN PREPPED FOR USE. THE BALLOON AND STENT 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. A PRODUCT MANDREL WAS INSERTED THROUGH THE LUMEN WITH NO RESTRICTIONS NOTED. 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

    REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(6) 2011. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, CROSSING DIFFICULTIES OCCURRED. ACCESS WAS OBTAINED THROUGH THE FEMORAL ARTERY. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE ECCENTRIC, MILDLY TORTUOUS AND MODERATELY CALCIFIED LEFT CIRCUMFLEX. THE LESION WAS PREDILATED WITH A 2.5X9MM MAVERICK BALLOON. NEXT, A 3.5X12MM PROMUS ELEMENT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH A NON-BSC BARE METAL STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE TIP DETACHED. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO AN APPROVED US DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911312350 13399890

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR 2.5X9MM MAVERICK BALLOON| BMW GUIDE WIRE