BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS PREMIER?

    MDR report key: 4202377 · Received October 27, 2014

    Report

    Report Number
    2134265-2014-06397
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Date of Event
    September 30, 2014
    Report Date
    September 30, 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

    DEVICE EVALUATED BY MANUFACTURER: THE STENT DELIVERY SYSTEM WAS RETURNED FOR ANALYSIS. SOLIDIFIED CONTRAST MEDIUM WAS VISIBLE IN THE INFLATION LUMEN INDICATING THE DEVICE WAS PREPPED FOR USE. THE TIP OUTER DIAMETER (OD) WAS MEASURED AND IS WITHIN SPECIFICATION. THE STENT WAS DAMAGED AT ITS DISTAL END. THE STRUTS ON THE MOST DISTAL ROWS WERE RAISED AND MISALIGNED. THIS TYPE OF DAMAGE IS CONSISTENT WITH THE STENT MEETING RESISTANCE DURING THE WITHDRAWAL OF THE DEVICE FROM THE PATIENT. 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. 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

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED AND SEVERELY TORTUOUS POSTERIOR OBTUSE MARGINAL BRANCH. A 24 X 2.25 PROMUS PREMIER¿ STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, THE DEVICE WAS UNABLE TO CROSS THE LESION. THE DEVICE WAS REMOVED AND UPON INSPECTION, IT WAS NOTED THAT THE STENT STRUTS WERE LIFTED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT'S STATUS WAS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED AND SEVERELY TORTUOUS POSTERIOR OBTUSE MARGINAL BRANCH. A 24 X 2.25 PROMUS PREMIER¿ STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, THE DEVICE WAS UNABLE TO CROSS THE LESION. THE DEVICE WAS REMOVED AND UPON INSPECTION, IT WAS NOTED THAT THE STENT STRUTS WERE LIFTED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT'S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681894 PROMUS PREMIER? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493925124220 16788009

    Patients

    Seq Age Sex Outcome Treatment
    1