BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2141776 · Received June 27, 2011

    Report

    Report Number
    2134265-2011-02429
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    March 30, 2011
    Report Date
    May 31, 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 MFR: A VISUAL AND MICROSCOPIC EXAMINATION FOUND THE DEVICE WAS RETURNED WITH THE STENT DISLODGED FROM THE STENT DELIVERY SYSTEM AND RESTING ON THE LUMEN. THE STENT WAS STRETCHED 4MM OVER THE DISTAL MARKERBAND AND 2MM OVER THE PROXIMAL MARKERBAND. THE STENT WAS DAMAGED ALONG IT'S LENGTH. THE TIP AND BALLOON SECTIONS OF THE DEVICE WERE VISUALLY AND MICROSCOPICALLY EXAMINED AND NO ISSUES WERE NOTED WITH THEIR PROFILES. THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO POSITIVE PRESSURE. MANDREL RESISTANCE WAS ENCOUNTERED DUE TO THE PRESENCE OF SOLIDIFIED BLOOD WITHIN THE GUIDEWIRE LUMEN. 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 STENTING TREATMENT PROCEDURE, DIFFICULTY CROSSING OCCURRED. THE 81% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT CIRCUMFLEX CORONARY ARTERY (LCX). THE LESION WAS PREDILATED WITH A 2.5X15MM MAVERICK2 BALLOON. A 2.75X24MM PROMUS ELEMENT STENT DELIVERY SYSTEM WAS THEN ADVANCED, BUT WAS UNABLE TO CROSS THE LESION. ADDITIONAL PREDILATION WAS PERFORMED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER PROMUS ELEMENT STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. HOWEVER, PRODUCT ANALYSIS REVEALED STENT DAMAGE AND THAT THE STENT HAD DISLODGED FROM THE BALLOON. 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 H7493911324270 13972804

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR 2.5X15MM MAVERICK2 BALLOON