BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ?

    MDR report key: 3935341 · Received July 15, 2014

    Report

    Report Number
    2134265-2014-04038
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Date of Event
    December 16, 2013
    Report Date
    June 17, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR.: A TACTILE AND VISUAL EXAMINATION FOUND THE UNIT WITH NO DEFECTS ON THE BALLOON AND TIP SECTIONS OF THE DEVICE. THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO POSITIVE PRESSURE. THE FIRST 5 ROWS OF THE STENT WERE UNDAMAGED AND IN THE CORRECT POSITION. THE REMAINING STRUTS ALONG THE LENGTH OF THE STENT WERE MISALIGNED AND STRETCHED OVER THE DISTAL MARKERBAND ENDING AT THE TIP OF THE DEVICE. THERE WERE NO KINKS OR DAMAGE 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 DEVICE ANALYSIS APPROVED ON (B)(4) 2014. IT WAS REPORTED THAT CROSSING DIFFICULTIES WAS ENCOUNTERED. THE TARGET LESION WAS LOCATED IN LEFT ANTERIOR DESCENDING ARTERY (LAD). A 2.75X20MM PROMUS ELEMENT DRUG-ELUTING STENT WAS SELECTED FOR USE AND ADVANCED BUT FAILED TO CROSS THE LESION. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413295 PROMUS ELEMENT ? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911320270 15885541

    Patients

    Seq Age Sex Outcome Treatment
    1