BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT ?

    MDR report key: 3050802 · Received April 10, 2013

    Report

    Report Number
    2134265-2013-02176
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 14, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: THE COMPLAINT DEVICE WAS RETURNED FOR ANALYSIS. A VISUAL AND MICROSCOPIC EXAMINATION OF THE DEVICE FOUND THE DEVICE WAS RETURNED TO THE COMPLAINT INVESTIGATION SITE WITH THE STRAIN RELIEF AND THE HUB/MANIFOLD OF THE CATHETER DETACHED. THE STRAIN RELIEF AND HUB/MANIFOLD WAS NOT RETURNED FOR ANALYSIS. THE STRUTS ON THE FIRST THREE ROWS ON THE PROXIMAL END OF THE STENT WERE MISALIGNED CAUSING SOME STRUTS TO BE BUNCHED TOGETHER AND RAISED UP. THE BALLOON AND TIP OF THE DEVICE WAS VISUALLY AND MICROSCOPICALLY EXAMINED AND NO ISSUES WERE NOTED WITH THEIR PROFILES THAT COULD HAVE POTENTIALLY CONTRIBUTED TO THE COMPLAINT INCIDENT. THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO POSITIVE PRESSURE. A VISUAL AND MICROSCOPIC EXAMINATION FOUND THAT THE HYPOTUBE WAS KINKED AT SEVERAL LOCATIONS ALONG ITS LENGTH. NO OTHER 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).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PERCUTANEOUS CORONARY INTERVENTION, A STENT DEFORMATION OCCURRED. THE 100% STENOSED CALCIFIED LESION WAS LOCATED IN THE MODERATELY TORTUOUS RIGHT CORONARY ARTERY. THE PHYSICIAN ADVANCED A 3.00X28MM PROMUS ELEMENT DRUG-ELUTING STENT, BUT IT FAILED TO CROSS THE LESION. SO THE PHYSICIAN ATTEMPTED TO REMOVE THE DEVICE FROM THE PATIENT BUT FAILED TO DO SO DUE TO THE RESISTANCE. THE DEVICE WAS REMOVED WITH A FORCEPS, AND IT WAS FOUND TO BE DEFORMED. TH PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PERCUTANEOUS CORONARY INTERVENTION, A STENT DEFORMATION OCCURRED. THE 100% STENOSED CALCIFIED LESION WAS LOCATED IN THE MODERATELY TORTUOUS RIGHT CORONARY ARTERY. THE PHYSICIAN ADVANCED A 3.00X28MM PROMUS ELEMENT DRUG-ELUTING STENT, BUT IT FAILED TO CROSS THE LESION. SO THE PHYSICIAN ATTEMPTED TO REMOVE THE DEVICE FROM THE PATIENT BUT FAILED TO DO SO DUE TO THE RESISTANCE. THE DEVICE WAS REMOVED WITH A FORCEPS, AND IT WAS FOUND TO BE DEFORMED. TH PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149483 PROMUS ELEMENT ? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911328300 15340376

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention