BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1954690 · Received January 10, 2011

    Report

    Report Number
    2134265-2010-05939
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Report Date
    November 22, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: VISUAL AND MICROSCOPIC EXAMINATION OF THE RETURNED DEVICE REVEALED A BREAK IN THE HYPOTUBE LOCATED 245MM DISTAL TO THE CATHETER STRAIN RELIEF. THERE WERE ALSO KINKS ALONG THE ENTIRE LENGTH OF THE HYPOTUBE SHAFT. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE TENSILE FORCE HAVING BEEN APPLIED TO THE SHAFT. THE STENT DELIVERY SYSTEM TIP, BALLOON AND STENT 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. SOLIDIFIED BLOOD WAS PRESENT WITHIN THE ENTIRE LENGTH OF THE INFLATION LUMEN, THEREFORE INDICATING THE DEVICE HAD BEEN USED IN VIVO. 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

    EVENT WAS DETERMINED TO BE REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(6) 2010. IT WAS REPORTED THAT PRIOR TO AN UNSPECIFIED PROCEDURE, A SHAFT KINK OCCURRED. THE LOCATION OF THE LESION IS UNKNOWN. DURING THE PROCEDURE, THE SHAFT OF THE 16MM X 2.50MM PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM KINKED DUE TO SEVERE FRICTION. NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT'S STATUS WAS REPORTED AS GOOD. RETURNED DEVICE ANALYSIS REVEALED A HYPOTUBE SHAFT BREAK. THIS PRODUCT IS ONLY OUS APPROVED BUT IT S 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 H7493911316250 0013618194

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR