BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2221225 · Received August 24, 2011

    Report

    Report Number
    2134265-2011-03573
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    June 13, 2011
    Report Date
    August 8, 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 A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: A VISUAL AND MICROSCOPIC EXAMINATION OF THE DEVICE FOUND THE DEVICE WAS RETURNED TO THE COMPLAINT INVESTIGATION SITE WITH PROXIMAL STENT DAMAGE. STENT STRUTS FROM THE MOST PROXIMAL ROW WERE BENT OUTWARDS DISTALLY. THE TIP AND BALLOON 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. THERE WERE KINKS IDENTIFIED ALONG THE ENTIRE LENGTH OF THE OUTER. THERE WERE ALSO KINKS IDENTIFIED ALONG THE ENTIRE LENGTH OF THE HYPOTUBE SHAFT. 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 GUIDEWIRE LUMEN WITH SOME RESISTANCE 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

    THIS COMPLAINT IS REPORTABLE BASED ON THE ANALYSIS COMPLETED ON (B)(6) 2011. IT WAS REPORTED THAT DURING AN STENTING TREATMENT PROCEDURE THE CATHETER WOULD NOT CROSS THE LESION. THE 83% STENOSED TARGET LESION BEING TREATED WAS LOCATED IN THE SEVERELY CALCIFIED AND SEVERELY TORTUOUS RIGHT CORONARY ARTERY (RCA). THE LESION WAS PRE-DILATED WITH 2.00X20MM MAVERICK BALLOON CATHETER. THE 2.75X28MM PROMUS ELEMENT STENT DELIVERY SYSTEM WAS ADVANCED TO THE RCA HOWEVER IT WAS UNABLE TO CROSS THE LESION. THE LESION WAS AGAIN PRE-DILATED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS STABLE. HOWEVER, THE RETURNED PRODUCT 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 H7493911328270 14236069

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR 2.0X20MM MAVERICK BALLOON CATHETER