BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS PREMIER?

    MDR report key: 3972638 · Received August 1, 2014

    Report

    Report Number
    2134265-2014-04626
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 14, 2014
    Report Date
    July 14, 2014
    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

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER.   DEVICE IS A COMBINATION PRODUCT.   (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE TIP OUTER DIAMETER WAS MEASURED USING A DIGITAL SNAP GAUGE WHICH IS WITHIN SPECIFICATION. THE STENT WAS DAMAGED. A STRUT IN THE PROXIMAL ROW OF STRUTS HAD BEEN 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. THE HYPOTUBE WAS KINKED AT VARIOUS LOCATIONS ALONG ITS LENGTH. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED TO THE DELIVERY SYSTEM. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS. 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 STENT DAMAGE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED AND SEVERELY TORTUOUS MIDDLE OF RIGHT CORONARY ARTERY. A 24 X 3.00 PROMUS PREMIER¿ STENT WAS SELECTED TO TREAT THE LESION; HOWEVER THE DEVICE WAS UNABLE TO CROSS THE LESION. WHEN THE DEVICE WAS REMOVED OUTSIDE THE PATIENT, IT WAS NOTICED THAT THE DISTAL EDGE OF THE STENT WAS DEFORMED AND WAS LIFTED. THE PROCEDURE WAS COMPLETED WITH AN UNSPECIFIED SIZE NON-BSC STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED AND SEVERELY TORTUOUS MIDDLE OF RIGHT CORONARY ARTERY. A 24 X 3.00 PROMUS PREMIER¿ STENT WAS SELECTED TO TREAT THE LESION; HOWEVER THE DEVICE WAS UNABLE TO CROSS THE LESION. WHEN THE DEVICE WAS REMOVED OUTSIDE THE PATIENT, IT WAS NOTICED THAT THE DISTAL EDGE OF THE STENT WAS DEFORMED AND WAS LIFTED. THE PROCEDURE WAS COMPLETED WITH AN UNSPECIFIED SIZE NON-BSC STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450489 PROMUS PREMIER? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493925124300 16837432

    Patients

    Seq Age Sex Outcome Treatment
    1