BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ¿ LONG

    MDR report key: 2870751 · Received December 12, 2012

    Report

    Report Number
    2134265-2012-07530
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Date of Event
    August 13, 2012
    Report Date
    November 14, 2012
    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

    (B)(4). DEVICE IS COMBINATION PRODUCT DEVICE EVALUATED BY MFR: A VISUAL AND MICROSCOPIC EXAMINATION OF THE RETURNED DEVICE REVEALED THE TIP WAS DAMAGED (THE EDGES WERE JAGGED LIKE). THIS TYPE OF DAMAGE IS CONSISTENT WITH THE TIP BEING PUSHED UP AGAINST A RESTRICTION, DURING ATTEMPTS TO CROSS THE LESION. THE BALLOON OF THE DEVICE WAS VISUALLY AND MICROSCOPICALLY EXAMINED AND IT WAS NOTED THAT THE PROXIMAL END OF THE BALLOON HAD A BUILD UP OF SOLIDIFIED CONTRAST MEDIA PRESENT WHICH HAS RESULTED IN THE PROXIMAL END OF THE STENT BEING SLIGHTLY FLARED. THE REST OF THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO ANY POSITIVE PRESSURE. SOLIDIFIED CONTRAST MEDIA WAS PRESENT WITHIN THE ENTIRE LENGTH OF THE INFLATION LUMEN, THEREFORE INDICATING THE DEVICE HAD BEEN PREPPED FOR USE. NO KINKS OR DAMAGE WERE NOTICED ALONG THE SHAFT OF 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 (B)(4) 2012. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE THE DEVICE WAS UNABLE TO CROSS THE LESION. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD). THE LESION WAS PREDILATED AND THEN A 2.50 X 38 MM PROMUS ELEMENT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LAD; HOWEVER, THE DEVICE WAS UNABLE TO CROSS THE LESION. THE DEVICE WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CURRENT CONDITION IS STABLE. HOWEVER, RETURNED PRODUCT ANALYSIS REVEALED STENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT ¿ LONG STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911338250 15162070

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR