BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ¿

    MDR report key: 2810345 · Received October 31, 2012

    Report

    Report Number
    2134265-2012-06613
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    October 8, 2012
    Report Date
    October 9, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    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 TO THE COMPLAINT INVESTIGATION SITE WITH THE STENT DISLODGED FROM THE BALLOON. 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. THERE WAS DAMAGE NOTED ALONG THE LENGTH OF THE STENT. BOTH ENDS OF THE STENT WERE MISALIGNED AND ON ONE END THE STRUTS WERE RAISED, THERE WAS ALSO SOME ROWS OF STRUTS TOWARDS THE CENTER OF THE STENT BUNCHED UP. THE BALLOON AND THE TIP 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 ANY POSITIVE PRESSURE. NO KINKS OR DAMAGED WAS NOTED TO THE SHAFT OF THE DEVICE. 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). DEVICE IS A COMBINATION PRODUCT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A STENTING TREATMENT PROCEDURE, A STENT DISLODGEMENT OCCURRED. A 2.25 X 24 MM PROMUS ELEMENT STENT DELIVERY SYSTEM WAS BEING UNPACKED WHEN IT WAS NOTED THAT THE STENT HAD DISLODGED FROM THE DELIVERY BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A STENTING TREATMENT PROCEDURE A STENT DISLODGEMENT OCCURRED. A 2.25X24MM PROMUS ELEMENT STENT DELIVERY SYSTEM WAS BEING UNPACKED WHEN IT WAS NOTED THAT THE STENT HAD DISLODGED FROM THE DELIVERY BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT ¿ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911324220 15002811

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR