BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ?

    MDR report key: 3081114 · Received April 26, 2013

    Report

    Report Number
    2134265-2013-02707
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    March 30, 2013
    Report Date
    April 1, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: INITIAL VISUAL EXAMINATION NOTED THAT THE STENT DELIVERY SYSTEM (SDS) WAS RETURNED TOGETHER WITH THE STENT. THE STENT WAS NOT SECURELY CRIMPED ON THE BALLOON. MICROSCOPIC EXAMINATION OF THE STENT FOUND THAT IT WAS SEVERELY DAMAGED, AS IT HAD BEEN CONSIDERABLY STRETCHED AND ITS PROFILE KINKED. THE MAJORITY OF THE STENT WAS STRETCHED DISTALLY AND A PORTION OF IT EXTENDED OUT OVER THE TIP OF THE DEVICE. NO ISSUES WERE NOTED WITH THE SDS OR THE BALLOON. NO FURTHER DAMAGE WAS 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). DEVICE EVALUATED BY MFR: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON PREPARATION FOR A PERCUTANEOUS CORONARY INTERVENTION, STENT DISLODGEMENT FROM THE BALLOON OCCURRED. A 2.25X32MM PROMUS ELEMENT - STENT WAS USED. WHILE UNPACKING THE DEVICE TO START PREPARATION, IT WAS NOTED THAT THE STENT WAS PARTIALLY DISLODGED FROM THE BALLOON. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON PREPARATION FOR A PERCUTANEOUS CORONARY INTERVENTION, STENT DISLODGEMENT FROM THE BALLOON OCCURRED. A 2.25X32MM PROMUS ELEMENT STENT WAS USED. WHILE UNPACKING THE DEVICE TO START PREPARATION, IT WAS NOTED THAT THE STENT WAS PARTIALLY DISLODGED FROM THE BALLOON. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182255 PROMUS ELEMENT ? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911332220 14808670

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR