BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2133320 · Received June 20, 2011

    Report

    Report Number
    2134265-2011-02458
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 2, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: A VISUAL AND MICROSCOPIC EXAMINATION OF THE DEVICE FOUND THE DEVICE WAS RETURNED TO THE COMPLAINT INVESTIGATION SITE WITH STENT DAMAGE. A STRUT TOWARDS THE MIDDLE OF THE STENT WAS RAISED AND MISALIGNED. THE PROXIMAL END OF THE STENT WAS RAISED SLIGHTLY. THE TIP AND BALLOON SECTIONS 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 POSITIVE PRESSURE. A PRODUCT MANDREL WAS INSERTED THROUGH THE LUMEN WITH NO RESTRICTIONS NOTED. 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. DEVICE EVALUATED BY MFR: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY ARTERY STENTING TREATMENT PROCEDURE STENT DAMAGE OCCURRED. THE TARGET LESIONS WERE LOCATED IN THE LAD (LEFT ANTERIOR DESCENDING). THE PHYSICIAN PLACED A 2.75X38MM PROMUS ELEMENT STENT IN THE DISTAL LAD AND THEN INTENDED TO PLACE A 3.5X28MM PROMUS ELEMENT STENT IN THE MID LAD. THERE WAS A PREVIOUSLY PLACED STENT IN THE PROXIMAL LAD THAT MADE IT DIFFICULT TO ADVANCE THE 3.5X28MM PROMUS ELEMENT STENT DELIVERY SYSTEM. MULTIPLE ATTEMPTS TO CROSS THE PREVIOUSLY PLACED STENT WERE MADE AND DAMAGE TO THE 3.5X28MM PROMUS ELEMENT STENT WAS NOTED. THE PROCEDURE WAS COMPLETED WITH A 3.5X30MM NON-BSC DRUG ELUTING STENT. ANOTHER NON-BSC STENT WAS ALSO PLACED IN THE LEFT MAIN CORONARY ARTERY. THERE WERE NO REPORTED PATIENT COMPLICATIONS AND THE PATIENT CONDITION WAS STABLE. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO AN APPROVED US DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY ARTERY STENTING TREATMENT PROCEDURE STENT DAMAGE OCCURRED. THE TARGET LESIONS WERE LOCATED IN THE LAD (LEFT ANTERIOR DESCENDING). THE PHYSICIAN PLACED A 2.75X38MM PROMUS ELEMENT STENT IN THE DISTAL LAD AND THEN INTENDED TO PLACE A 3.5X28MM PROMUS ELEMENT STENT IN THE MID LAD. THERE WAS A PREVIOUSLY PLACED STENT IN THE PROXIMAL LAD THAT MADE IT DIFFICULT TO ADVANCE THE 3.5X28MM PROMUS ELEMENT STENT DELIVERY SYSTEM. MULTIPLE ATTEMPTS TO CROSS THE PREVIOUSLY PLACED STENT WERE MADE AND DAMAGE TO THE 3.5X28MM PROMUS ELEMENT STENT WAS NOTED. THE PROCEDURE WAS COMPLETED WITH A 3.5X30MM NON-BSC DRUG ELUTING STENT. ANOTHER NON-BSC STENT WAS ALSO PLACED IN THE LEFT MAIN CORONARY ARTERY. THERE WERE NO REPORTED PATIENT COMPLICATIONS AND THE PATIENT CONDITION WAS STABLE. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO AN APPROVED US DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911328350 14179552

    Patients

    Seq Age Sex Outcome Treatment
    1