BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2012453 · Received March 9, 2011

    Report

    Report Number
    2134265-2011-00668
    Event Type
    Malfunction
    Date Received
    March 9, 2011
    Date of Event
    February 9, 2011
    Report Date
    February 11, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: A VISUAL AND MICROSCOPIC EXAMINATION REVEALED THAT THE STENT WAS DISLODGED FROM THE DELIVERY DEVICE AND RETURNED ON A PRODUCT MANDREL. AN UNDAMAGED STENT PROTECTOR WAS COVERING A SMALL SECTION OF THE STENT. THE STENT PROTECTOR WAS REMOVED EASILY WITH NO FORCE REQUIRED. THE STENT WAS STRETCHED AND MISALIGNED ALONG IT'S LENGTH. SOLIFIED CONTRAST MEDIA WAS PRESENT WITHIN THE BALLOON, INDICATING THAT THE BALLOON HAD BEEN INFLATED DURING THE PROCEDURE. THE BALLOON WAS RETURNED FULLY DEFLATED. SOLIDIFIED BLOOD WAS PRESENT WITHIN THE ENTIRE LENGTH OF THE INFLATION LUMEN, THEREFORE INDICATING THE DEVICE HAD BEEN USED IN VIVO. THE TIP SECTION OF THE DEVICE WAS VISUALLY AND MICROSCOPICALLY EXAMINED AND NO ISSUES WERE NOTED WITH IT'S PROFILE THAT COULD HAVE POTENTIALLY CONTRIBUTED TO THE COMPLAINT INCIDENT. 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

    DEVICE IS A COMBINATION PRODUCT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, STENT DISLODGEMENT OCCURRED. THE STENT DISLODGED FROM THE BALLOON BEFORE STARTING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, STENT DISLODGEMENT OCCURRED. THE STENT DISLODGED FROM THE BALLOON BEFORE STARTING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    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 H7493911312220 13626096

    Patients

    Seq Age Sex Outcome Treatment
    1