BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT¿ PLUS

    MDR report key: 2831813 · Received November 14, 2012

    Report

    Report Number
    2134265-2012-07203
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 18, 2012
    Report Date
    October 18, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    UPDATED: DEVICE EVALUATED BY MFR, EVAL. SUMMARY ATTACHED, METHOD CODES, RESULT CODES, CONCLUSION CODES. DEVICE EVALUATED BY MFR: THE STENT HAD NOT DISLODGED FROM THE DEVICE AND THE LUMEN WAS KINKED THROUGHOUT. A VISUAL AND MICROSCOPIC EXAMINATION IDENTIFIED A BREAK AT THE MIDSHAFT. IT WAS ALSO NOTED THAT THE LUMEN WAS KINKED IN VARIOUS LOCATIONS THROUGHOUT. THE CRIMPED STENT, BALLOON AND TIP SECTIONS 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 POSITIVE PRESSURE. 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT UNPACKING BEFORE A STENTING TREATMENT PROCEDURE A SHAFT BREAKAGE OCCURRED AND THE STENT DISLODGED. WHEN THE PHYSICIAN TRIED TO INTRODUCE THE STENT ON THE UNSPECIFIED GUIDE THERE WAS A BREAK BETWEEN THE TRANSPARENT FLEXIBLE AREA AND THE BACK RIGID AREA. THE BALLOON AND STENT DISLODGED OF THE UNSPECIFIED CATHETER GUIDE. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT UNPACKING BEFORE A STENTING TREATMENT PROCEDURE A SHAFT BREAKAGE OCCURRED AND THE STENT DISLODGED. WHEN THE PHYSICIAN TRIED TO INTRODUCE THE STENT ON THE UNSPECIFIED GUIDE THERE WAS A BREAK BETWEEN THE TRANSPARENT FLEXIBLE AREA AND THE BACK RIGID AREA. THE BALLOON AND STENT DISLODGED OF THE UNSPECIFIED CATHETER GUIDE. THE PROCEDURE WAS COMPLETED WITH ANOTHER 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¿ PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493918408250 0015291383

    Patients

    Seq Age Sex Outcome Treatment
    1