BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ¿

    MDR report key: 3002796 · Received March 13, 2013

    Report

    Report Number
    2134265-2013-01478
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    February 15, 2013
    Report Date
    February 15, 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.: A VISUAL AND MICROSCOPIC EXAMINATION IDENTIFIED DISTAL STENT DAMAGE. THE STRUTS ON THE FIRST ROW ON THE DISTAL END OF THE STENT WAS RAISED UP. THIS DAMAGE IS CONSISTENT WITH THE STENT MEETING RESISTANCE UPON ADVANCEMENT. THE BALLOON AND THE TIP OF THE DEVICE WERE 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 ANY POSITIVE PRESSURE. 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).

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE APICAL ARTERY. THE LESION WAS ABLATED WITH A ROTA ROTATIONAL ATHERECTOMY DEVICE. THE 2.5 X 28MM PROMUS ELEMENT MR STENT DELIVERY SYSTEM (SDS) WAS ADVANCED, BUT WAS UNABLE TO CROSS THE LESION. THE SDS WAS REMOVED AND THE LESION WAS DILATED WITH AN UNSPECIFIED BALLOON. THE SDS WAS RE-ADVANCED, BUT WAS UNABLE TO CROSS THE LESION. THE DEVICE WAS EXAMINED AND IT WAS NOTED THAT THE DISTAL PORTION OF THE STENT WAS LIFTED. THE PROCEDURE WAS COMPLETED WITH 2 NON BSC STENTS, WITH THE SECOND STENT BEING IMPLANTED PROXIMAL TO THE 1ST IMPLANTED IN THE LESION. AN UNSPECIFIED IVUS WAS PERFORMED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE APICAL ARTERY. THE LESION WAS ABLATED WITH A ROTA ROTATIONAL ATHERECTOMY DEVICE. THE 2.5 X 28MM PROMUS ELEMENT MR STENT DELIVERY SYSTEM (SDS) WAS ADVANCED, BUT WAS UNABLE TO CROSS THE LESION. THE SDS WAS REMOVED AND THE LESION WAS DILATED WITH AN UNSPECIFIED BALLOON. THE SDS WAS RE-ADVANCED, BUT WAS UNABLE TO CROSS THE LESION. THE DEVICE WAS EXAMINED AND IT WAS NOTED THAT THE DISTAL PORTION OF THE STENT WAS LIFTED. THE PROCEDURE WAS COMPLETED WITH 2 NON BSC STENTS, WITH THE SECOND STENT BEING IMPLANTED PROXIMAL TO THE 1ST IMPLANTED IN THE LESION. AN UNSPECIFIED IVUS WAS PERFORMED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105671 PROMUS ELEMENT ¿ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911328250 15006377

    Patients

    Seq Age Sex Outcome Treatment
    1