BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ?

    MDR report key: 3192297 · Received June 27, 2013

    Report

    Report Number
    2134265-2013-04647
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    April 25, 2013
    Report Date
    June 10, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. (B)(4). DEVICE EVALUATED BY MFR: A VISUAL AND MICROSCOPIC EXAMINATION OF THE RETURNED DEVICE NOTED THAT THE STENT WAS DAMAGED. STRUT ROWS FROM THE DISTAL AND PROXIMAL ENDS OF THE STENT WERE RAISED FROM THE BALLOON AND MISALIGNED. THE APPEARANCE OF THE RAISED DISTAL AND PROXIMAL STRUTS WOULD SUGGEST THAT THE INFLATION PROCEDURE HAD BEGUN. THE BALLOON WAS SLIGHTLY INFLATED AT BOTH ENDS OF THE STENT. THE TIP SECTION OF THE DEVICE WAS VISUALLY AND MICROSCOPICALLY EXAMINED AND NO ISSUES WERE NOTED WITH ITS PROFILE. NO KINKS OR DAMAGE WERE NOTICED ALONG THE SHAFT OF THE DEVICE. NO OTHER ISSUES WERE NOTED WITH THE DEVICE. 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)(4) 2013. IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY TREATMENT PROCEDURE, CROSSING DIFFICULTY OCCURED. THE DE NOVO TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED AND MILDLY TORTUOUS MID LEFT CIRCUMFLEX ARTERY. AFTER PREDILATION USING AN UNSPECIFIED BALLOON CATHETER, A 4.00MM X 28MM PROMUS ELEMENT STENT WAS ADVANCED BUT WAS NOT ABLE TO CROSS THE TARGET LESION. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE. RETURNED DEVICE ANALYSIS REVEALED STENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292296 PROMUS ELEMENT ? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911328400 14889629

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR