BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2073689 · Received May 2, 2011

    Report

    Report Number
    2134265-2011-01523
    Event Type
    Malfunction
    Date Received
    May 2, 2011
    Date of Event
    March 31, 2011
    Report Date
    April 8, 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

    A VISUAL AND MICROSCOPIC ANALYSIS OF THE RETURNED DEVICE INDICATED THAT THERE WAS A BREAK OF BOTH THE INNER AND OUTER LUMEN 3MM DISTAL TO THE PORT AREA AT THE PORT WELD BOND. THE BREAK SITE HAD A JAGGED EDGE. THIS RESULTED IN THE EXPOSURE OF 52MM OF THE COREWIRE. THERE WAS ALSO A KINK IN MIDSHAFT AND CORRESPONDING SECTION OF THE COREWIRE JUST PROXIMAL TO THE PORT AREA. THERE WERE KINKS ALONG THE ENTIRE LENGTH OF THE HYPOTUBE. THE DISTAL SECTION OF THE DEVICE WAS RETURNED ON A GUIDEWIRE. THE GUIDEWIRE COULD NOT BE REMOVED. THE OUTER LUMEN WAS KINKED ALONG ITS ENTIRE LENGTH. THE HYPOTUBE WAS KINKED ALONG IT'S ENTIRE LENGTH. THE STENT 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. SOLIDIFIED BLOOD WAS PRESENT WITHIN THE ENTIRE LENGTH OF THE INFLATION LUMEN, THEREFORE INDICATING THE DEVICE HAD BEEN USED IN VIVO. NO FURTHER PRODUCT ANALYSIS WAS PERFORMED AT THIS TIME. 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 PERCUTANEOUS CORONARY INTERVENTION SHAFT FRACTURE OCCURED WITH THE 2.25X12MM PROMUS ELEMENT STENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT 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 PERCUTANEOUS CORONARY INTERVENTION SHAFT FRACTURE OCCURED WITH THE 2.25X12MM PROMUS ELEMENT STENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT 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 H7493911312220 14004744

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR