BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1863960 · Received October 11, 2010

    Report

    Report Number
    2134265-2010-04580
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Date of Event
    September 30, 2010
    Report Date
    September 30, 2010
    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 MANUFACTURER- EXAMINATION OF THE RETURNED COMPLAINT DEVICE REVEALED STENT DAMAGE AND A SHAFT KINKS. ON ROW 8 FROM THE PROXIMAL END, A STENT STRUT WAS RAISED. THE OUTER DIAMETER OF THE UNDAMAGED PORTION OF THE STENT MET SPECIFICATIONS. THERE WERE SEVERAL KINKS ALONG THE LENGTH OF THE HYPOTUBE SHAFT. FURTHER EXAMINATION OF THE BALLOON AND TIP SECTIONS OF THE DEVICE FOUND NO ISSUES WITH THEIR PROFILES THAT COULD HAVE CONTRIBUTED TO THE EVENT. THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO POSITIVE PRESSURE. ATTEMPTS TO INSERT A 0.015 INCH PRODUCT MANDREL WERE UNSUCCESSFUL DUE TO THE PRESENCE OF SOLIDIFIED CONTRAST MEDIA AND SOLIDIFIED BLOOD WITHIN THE ENTIRE LENGTH OF THE LUMEN. 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

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. WHEN THE 2.5X38MM PROMUS ELEMENT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED THROUGH THE Y-ADAPTER INTO THE GUIDE CATHETER, RESISTANCE WAS NOTED. THE PHYSICIAN REMOVED THE SDS AND NOTED THAT THE STENT STRUTS WERE BENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS 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 STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. WHEN THE 2.5X38MM PROMUS ELEMENT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED THROUGH THE Y-ADAPTER INTO THE GUIDE CATHETER, RESISTANCE WAS NOTED. THE PHYSICIAN REMOVED THE SDS AND NOTED THAT THE STENT STRUTS WERE BENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS 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 H7493911338250 0013246280

    Patients

    Seq Age Sex Outcome Treatment
    1