BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2140461 · Received June 27, 2011

    Report

    Report Number
    2134265-2011-02383
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    May 30, 2011
    Report Date
    May 30, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: A VISUAL AND MICROSCOPIC EXAMINATION OF THE DEVICE FOUND THE DEVICE WAS RETURNED WITH THE STENT DISLODGED AND INSIDE THE DEVICE'S STENT PROTECTOR. THE STENT PROTECTOR WAS CUT OFF THE STENT. THE STENT IS DAMAGED AT A NUMBER OF POINTS ALONG IT'S LENGTH, A STRUT AT ONE END OF THE STENT IS RAISED AND ONE END OF THE STENT APPEARS TO HAVE NARROWED. THE STENT STRUTS ARE SEPARATED AT MULTIPLE POINTS ALONG IT'S LENGTH. THE BALLOON WAS FOUND TO HAVE THE STENT IMPRESSIONS ON IT AND PILLOWING OF THE BALLOON INDICATING THAT THE STENT WAS CRIMPED PER PROCESS IN THE CORRECT LOCATION DURING MANUFACTURING. A PRODUCT MANDREL WAS INSERTED THROUGH THE LUMEN WITH NO RESTRICTIONS NOTED. THE TIP SECTION OF THE DEVICE WAS VISUALLY AND MICROSCOPICALLY EXAMINED AND NO ISSUES WERE NOTED WITH IT'S PROFILE THAT COULD HAVE POTENTIALLY CONTRIBUTED TO THE COMPLAINT INCIDENT. 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

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A STENTING TREATMENT PROCEDURE STENT DISLODGEMENT OCCURRED. WHILE UNPACKING THE 3.00X12MM PROMUS ELEMENT STENT DELIVERY SYSTEM (SDS), IT WAS NOTED THAT THE STENT HAD DISLODGED FROM THE STENT DELIVERY BALLOON. IT WAS NOTED THAT THE STERILE BARRIER OF THE PACKAGE WAS INTACT AND THERE WAS NO EVIDENCE OF DAMAGE TO THE EXTERNAL PACKAGING OF THE DEVICE. THE DEVICE NEVER ENTERED THE PATIENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT DEVICE WITH NO PATIENT COMPLICATIONS REPORTED. THE PATIENT'S CURRENT CONDITION IS LISTED AS FINE. 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 PREPARATION FOR A STENTING TREATMENT PROCEDURE STENT DISLODGEMENT OCCURRED. WHILE UNPACKING THE 3.00X12MM PROMUS ELEMENT STENT DELIVERY SYSTEM (SDS), IT WAS NOTED THAT THE STENT HAD DISLODGED FROM THE STENT DELIVERY BALLOON. IT WAS NOTED THAT THE STERILE BARRIER OF THE PACKAGE WAS INTACT AND THERE WAS NO EVIDENCE OF DAMAGE TO THE EXTERNAL PACKAGING OF THE DEVICE. THE DEVICE NEVER ENTERED THE PATIENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT DEVICE WITH NO PATIENT COMPLICATIONS REPORTED. THE PATIENT'S CURRENT CONDITION IS LISTED AS FINE. 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 H7493911312300 13818032

    Patients

    Seq Age Sex Outcome Treatment
    1