BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1823927 · Received September 2, 2010

    Report

    Report Number
    2134265-2010-03835
    Event Type
    Malfunction
    Date Received
    September 2, 2010
    Date of Event
    August 4, 2010
    Report Date
    August 9, 2010
    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 MANUFACTURER - A VISUAL AND MICROSCOPIC EXAMINATION FOUND DISTAL STENT DAMAGE. THE STRUTS OF ROW ONE WERE RAISED AND MISALIGNED. 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. A PRODUCT MANDREL WAS INSERTED THROUGH THE LUMEN WITH NO RESTRICTIONS NOTED. A VISUAL AND MICROSCOPIC EXAMINATION IDENTIFIED NO KINKS ALONG THE LENGTH OF THE HYPOTUBE SHAFT. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE CLASSIFICATION 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 STENTING TREATMENT PROCEDURE, STENT DAMAGE WAS NOTED. ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY. THE 70% STENOSED, ECCENTRIC, DE NOVO LESION MEASURING 2.75MM IN DIAMETER AND 13MM IN LENGTH WAS LOCATED IN A MILDLY CALCIFIED AND NON-TORTUOUS PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). THE PHYSICIAN ATTEMPTED TO DIRECT STENT WITH A 2.75X16MM PROMUS ELEMENT STENT, BUT ENCOUNTERED DIFFICULTY IN CROSSING THE LESION. WHEN THE DEVICE WAS REMOVED FROM THE PATIENT, STENT DAMAGE WAS NOTED. THE PROCEDURE WAS COMPLETED WITH A 2.75X18MM NON BSC STENT. NO PATIENT COMPLICATIONS WERE REPORTED. PATIENT STATUS IS STABLE. 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 H7493911316270 13158622

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR ATW GUIDE WIRE| XB 3.5 CORDIS GUIDE CATHETER