BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ?

    MDR report key: 3030176 · Received April 2, 2013

    Report

    Report Number
    2134265-2013-01885
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 5, 2013
    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 EVALUATED BY MFR: THE COMPLAINT DEVICE HAS BEEN RETURNED FOR ANALYSIS. A VISUAL AND MICROSCOPIC EXAMINATION IDENTIFIED STENT DAMAGE. THE STENT HAD MOVED DISTALLY ON THE BALLOON BY 5MM AND WAS SITTING ON THE TIP OF THE DEVICE. THE STENT WAS STRETCHED AND DAMAGED ALONG ITS LENGTH. THE DAMAGE NOTED TO THE STENT CAUSED SOME OF THE STRUTS BETWEEN THE THIRD ROW IN ON FROM THE PROXIMAL END OF THE STENT TO THE EIGHTH ROW IN FROM THE DISTAL END OF THE STENT TO BE RAISED UP. THE BALLOON WAS FOUND TO HAVE THE STENT IMPRESSIONS ON IT AND PILLOWING OF THE BALLOON INDICATING THAT THE STENT WAS CRIMPED PER PROCESS IN THE CORRECT LOCATION DURING MANUFACTURING. THE BALLOON OF THE DEVICE WAS VISUALLY AND MICROSCOPICALLY EXAMINED AND NO ISSUES WERE NOTED. THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO POSITIVE PRESSURE. THERE WAS NO DAMAGE NOTED TO THE TIP OF THE DEVICE. 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).

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT 18 YEARS OR OLDER. DEVICE IS A COMBINATION PRODUCT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY ARTERY STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. THE 99% STENOSED LESION BEING TREATED WAS LOCATED IN A, CALCIFIED, MODERATELY TORTUOUS PORTION OF THE LEFT CIRCUMFLEX. THE PHYSICIAN PRE-DILATED THE LESION AND ADVANCED THE 3.0X24MM PROMUS ELEMENT STENT. THE PHYSICIAN FELT RESISTANCE DUE TO THE TORTUOSITY. THE STENT WAS REMOVED AND THE PHYSICIAN NOTICED THAT THE STENT HAD BECOME DEFORMED. THE PHYSICIAN COMPLETED THE PROCEDURE WITH A DIFFERENT STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY ARTERY STENTING TREATMENT PROCEDURE STENT DAMAGE OCCURRED. THE 99% STENOSED LESION BEING TREATED WAS LOCATED IN A, CALCIFIED, MODERATELY TORTUOUS PORTION OF THE LEFT CIRCUMFLEX. THE PHYSICIAN PRE-DILATED THE LESION AND ADVANCED THE 3.0X24MM PROMUS ELEMENT STENT. THE PHYSICIAN FELT RESISTANCE DUE TO THE TORTUOSITY. THE STENT WAS REMOVED AND THE PHYSICIAN NOTICED THAT THE STENT HAD BECOME DEFORMED. THE PHYSICIAN COMPLETED THE PROCEDURE WITH A DIFFERENT STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135043 PROMUS ELEMENT ? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911324300 14951728

    Patients

    Seq Age Sex Outcome Treatment
    1