BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2133181 · Received June 20, 2011

    Report

    Report Number
    2134265-2011-02394
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Date of Event
    May 27, 2011
    Report Date
    May 27, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: A VISUAL AND MICROSCOPIC EXAMINATION OF THE DEVICE FOUND THE DEVICE WAS RETURNED WITH PROXIMAL STENT DAMAGE. STRUT ROWS TOWARDS THE PROXIMAL END OF THE STENT WERE RAISED FROM THE BALLOON AND MISALIGNED. THIS TYPE OF DAMAGE IS CONSISTENT WITH THE STENT MEETING RESISTANCE UPON ADVANCEMENT AND/OR WITHDRAWAL. THE OUTER DIAMETER (OD) OF THE PROXIMAL STENT DAMAGE WAS APPROXIMATELY 1.27 MM. THE OD OF THE STENT AREA WHERE NO DAMAGE WAS PRESENT WAS MEASURED AT APPROXIMATELY 0.97 MM. 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. NO KINKS OR DAMAGE WERE NOTICED ALONG THE SHAFT OF THE DEVICE. CONTRAST MEDIA WAS PRESENT WITHIN THE INFLATION LUMEN, THEREFORE INDICATING THAT THE DEVICE WAS PREPPED FOR USE. SOLIDIFIED BLOOD WAS ALSO PRESENT WITHIN THE INFLATION LUMEN, THEREFORE INDICATING THE DEVICE HAD BEEN USED IN VIVO. A 0.015 INCH PRODUCT MANDREL WAS INSERTED THROUGH THE LUMEN WITH SOME RESISTANCE 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY ARTERY STENTING TREATMENT PROCEDURE STENT DAMAGE OCCURRED. THE 2.25X32MM PROMUS ELEMENT STENT DELIVERY SYSTEM WAS INSERTED TO BE ADVANCED TO AN UNSPECIFIED LESION. THE PHYSICIAN EXPERIENCED DIFFICULTY DELIVERING THE STENT DELIVERY SYSTEM TO THE DESIRED LOCATION AND REMOVED THE DEVICE. UPON REMOVAL, THE DISTAL END OF THE STENT HAD THE STRUTS BENT BACKWARDS. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. 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 2.25X32MM PROMUS ELEMENT STENT DELIVERY SYSTEM WAS INSERTED TO BE ADVANCED TO AN UNSPECIFIED LESION. THE PHYSICIAN EXPERIENCED DIFFICULTY DELIVERING THE STENT DELIVERY SYSTEM TO THE DESIRED LOCATION AND REMOVED THE DEVICE. UPON REMOVAL, THE DISTAL END OF THE STENT HAD THE STRUTS BENT BACKWARDS. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. 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 H7493911332220 0014025708

    Patients

    Seq Age Sex Outcome Treatment
    1