BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS PREMIER?

    MDR report key: 3822459 · Received May 20, 2014

    Report

    Report Number
    2134265-2014-02699
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    April 22, 2014
    Report Date
    April 22, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: A VISUAL EXAMINATION OF THE STENT FOUND THAT THE CRIMPED STENT ON THE DEVICE WAS DAMAGED. IT WAS NOTED THAT STENT STRUTS AT THE MID-SECTION AND THE PROXIMAL END WERE LIFTED, STRETCHED AND DEFORMED. THE BUMPER TIP OF THE DEVICE SHOWED NO SIGNS OF DAMAGE. THE BALLOON CONE PROFILES WERE REVIEWED AND NO ISSUES WERE NOTED WITH THE OVERALL BALLOON PROFILE. THE BALLOON WINGS WERE TIGHTLY WRAPPED AND EVENLY FOLDED AND WERE NOT SUBJECTED TO POSITIVE PRESSURE. A VISUAL AND TACTILE EXAMINATION FOUND MULTIPLE KINKS ALONG THE LENGTH OF THE HYPOTUBE AND THAT THE INNER LUMEN WITHIN THE BALLOON SECTION OF THE EXTRUSION WAS KINKED. THE KINK CORRESPONDS IN LOCATION TO THAT OF THE DAMAGE EVIDENT ON THE CRIMPED STENT; THE STENT MID-SECTION. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CALCIFIED MID RIGHT CORONARY ARTERY. THE VESSEL WAS PREDILATED WITH A 2.5 X 30 EMERGE BALLOON. AN ATTEMPT TO PLACE THE PROMUS PREMIER 2.75MM X 16MM STENT WAS MADE BUT WAS UNABLE TO CROSS THE LESION. IT WAS NOTED UPON REMOVAL OF THE DEVICE, THE STENT WAS STILL INTACT HOWEVER THE STRUTS WERE DEFORMED AND THE HYPOTUBE WAS KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CALCIFIED MID RIGHT CORONARY ARTERY. THE VESSEL WAS PREDILATED WITH A 2.5 X 30 EMERGE BALLOON. AN ATTEMPT TO PLACE THE PROMUS PREMIER 2.75MM X 16MM STENT WAS MADE BUT WAS UNABLE TO CROSS THE LESION. IT WAS NOTED UPON REMOVAL OF THE DEVICE, THE STENT WAS STILL INTACT HOWEVER THE STRUTS WERE DEFORMED AND THE HYPOTUBE WAS KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300113 PROMUS PREMIER? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493952816270 16435645

    Patients

    Seq Age Sex Outcome Treatment
    1