BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2160096 · Received July 13, 2011

    Report

    Report Number
    2134265-2011-02774
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    May 2, 2011
    Report Date
    June 23, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS RETURNED FOR ANALYSIS. A VISUAL AND MICROSCOPIC EXAMINATION OF THE DEVICE IDENTIFIED THAT THE TIP OF THE DEVICE WAS SLIGHTLY FLARED. THIS TYPE OF DAMAGE IS CONSISTENT WITH GUIDEWIRE MOVEMENT DURING ATTEMPTS TO CROSS THE LESION. THE STENT WAS DAMAGED ALONG ITS ENTIRE LENGTH. THE OUTER DIAMETER (OD) OF THE STENT DAMAGE WAS MEASURED AND WAS APPROXIMATELY 1.25MM. THE HYPOTUBE WAS KINKED ALONG ITS ENTIRE LENGTH. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED TO THE DELIVERY SYSTEM. A 0.015 INCH 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 PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, CROSSING DIFFICULTIES OCCURRED. THE 82% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY. AFTER PRE-DILATING THE LESION, THE 2.50X16MM PROMUS ELEMENT STENT WAS ADVANCED BUT FAILED TO CROSS THE TARGET LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER PROMUS ELEMENT STENT WITH NO PATIENT COMPLICATIONS. THE PATIENT'S STATUS IS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT DAMAGE. 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 H7493911312250 0014170292

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR