BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2020480 · Received March 16, 2011

    Report

    Report Number
    2134265-2011-00725
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    December 25, 2010
    Report Date
    February 16, 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 EXAMINATION OF THE DEVICE FOUND THAT THE STENT OF THIS DEVICE WAS NOT RETURNED. THE BALLOON WAS RETURNED DEFLATED AND CONTAINING SOLIDIFIED CONTRAST MEDIA. MANDREL RESISTANCE WAS ENCOUNTERED DUE TO THE PRESENCE OF SOLIDIFIED CONTRAST MEDIA WITHIN THE ENTIRE LENGTH OF THE INFLATION LUMEN, THEREFORE INDICATING THE DEVICE HAD BEEN PREPPED FOR USE. THE TIP 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).

    Description of Event or Problem · 1

    REPORTABLE BASED ON ADDITIONAL INFORMATION RECEIVED (B)(6) 2011. IT WAS REPORTED THAT DURING A CORONARY ARTERY STENTING TREATMENT PROCEDURE CROSSING DIFFICULTY OCCURRED. THE PATIENT PRESENTED FOR THE PROCEDURE WITH CHEST PAIN. A 95% STENOSED LESION OF THE SEVERLY CALCIFIED, MILDLY TORTUOUS PDA (POSTERIOR DESCENDING ARTERY) WAS IDENTIFIED. A 2.0X20MM SEMICOMPLIANT BALLOON WAS USED TO PREDILATE THE LESION AND A 2.5X28MM PROMUS ELEMENT STENT WAS ADVANCED BUT COULD NOT CROSS THE LESION. A 2.5X16MM PROMUS ELEMENT WAS ALSO ATTEMPTED BUT FAILED TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH BALLOON ANGIOPLASTY. THERE WERE NO REPORTED PATIENT COMPLICATIONS AND THE PATIENT CONDITION WAS STABLE. HOWEVER, THE RETURNED PRODUCT SHOWED THE 2.5X28MM PROMUS ELEMENT STENT HAD DISLODGED. 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 H7493911328250 13566324

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR