BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1901592 · Received November 17, 2010

    Report

    Report Number
    2134265-2010-05101
    Event Type
    Malfunction
    Date Received
    November 17, 2010
    Date of Event
    October 29, 2010
    Report Date
    November 2, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER - A VISUAL AND MICROSCOPIC EXAMINATION OF THE DEVICE FOUND THE DEVICE WAS RETURNED TO THE COMPLAINT INVESTIGATION SITE WITH STENT DAMAGE. THE STENT STRUTS WERE STRETCHED FROM THE FOURTH ROW FROM THE PROXIMAL END AND OVER THE TIP OF THE DEVICE. THIS TYPE OF DAMAGE IS CONSISTENT WITH THE STENT MEETING RESISTANCE UPON ADVANCEMENT AND/OR WITHDRAWAL. THERE WERE ALSO KINKS IDENTIFIED ALONG THE ENTIRE LENGTH OF THE HYPOTUBE SHAFT. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED TO THE DELIVERY SYSTEM. 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. SOLIDIFIED BLOOD WAS PRESENT WITHIN THE ENTIRE LENGTH OF THE INFLATION LUMEN, THEREFORE INDICATING THE DEVICE HAD BEEN USED IN VIVO. 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 CLASSIFICATION 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 STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. THE LESION WAS LOCATED IN AN UNSPECIFIED CORONARY ARTERY. THE PHYSICIAN ATTEMPTED TO ADVANCE A 3.5X38MM PROMUS ELEMENT STENT THROUGH A HAEMOSTATIC VALVE OUTSIDE THE PATIENT WHEN RESISTANCE WAS NOTED AND THE PHYSICIAN COULD NOT PASS THE DEVICE THROUGH THE VALVE. WHEN THE DEVICE WAS EXAMINED, STENT DAMAGE WAS NOTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER STENT. NO PATIENT COMPLICATIONS WERE REPORTED. PATIENT STATUS IS LISTED AS FINE. THIS DEVICE 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. THE LESION WAS LOCATED IN AN UNSPECIFIED CORONARY ARTERY. THE PHYSICIAN ATTEMPTED TO ADVANCE A 3.5X38MM PROMUS ELEMENT STENT THROUGH A HAEMOSTATIC VALVE OUTSIDE THE PATIENT WHEN RESISTANCE WAS NOTED AND THE PHYSICIAN COULD NOT PASS THE DEVICE THROUGH THE VALVE. WHEN THE DEVICE WAS EXAMINED, STENT DAMAGE WAS NOTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER STENT. NO PATIENT COMPLICATIONS WERE REPORTED. PATIENT STATUS IS LISTED AS FINE. THIS DEVICE 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 H7493911338350 13602258

    Patients

    Seq Age Sex Outcome Treatment
    1