BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2140424 · Received June 27, 2011

    Report

    Report Number
    2134265-2011-02577
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    June 9, 2011
    Report Date
    June 10, 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 MANUFACTURER - A VISUAL AND MICROSCOPIC EXAMINATION OF THE DEVICE IDENTIFIED DISTAL STENT DAMAGE. THE DISTAL HALF OF THE STENT WAS STRETCHED TO 2MM DISTAL OF THE DISTAL END OF THE TIP OF THE DEVICE. NO ISSUES WERE NOTED WITH THE BALLOON AND TIP SECTIONS OF THE DEVICE 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. A 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 IS CONSIDERED HANDLING DAMAGE AS THE EVENT OCCURRED PRIOR TO PATIENT CONTACT. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO A PERCUTANEOUS CORONARY INTERVENTION, STENT DAMAGE OCCURRED. THE 2.5X32MM PROMUS ELEMENT STENT WAS REMOVED FROM PACKAGE AND INSPECTED PRIOR TO USE, UPON INSPECTION IT WAS NOTED THAT THE STENT WAS DEFORMED AND IRREGULAR IN APPEARANCE. THE DEVICE WAS NOT USED AND 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 PRIOR TO A PERCUTANEOUS CORONARY INTERVENTION, STENT DAMAGE OCCURRED. THE 2.5X32MM PROMUS ELEMENT STENT WAS REMOVED FROM PACKAGE AND INSPECTED PRIOR TO USE, UPON INSPECTION IT WAS NOTED THAT THE STENT WAS DEFORMED AND IRREGULAR IN APPEARANCE. THE DEVICE WAS NOT USED AND 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 H7493911332250 0014132375

    Patients

    Seq Age Sex Outcome Treatment
    1