BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT? PLUS

    MDR report key: 3043088 · Received April 9, 2013

    Report

    Report Number
    2134265-2013-02095
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 11, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR., EVAL SUMMARY ATTACHED, METHOD CODES, RESULT CODES, CONCLUSION CODES UPDATED. DEVICE EVALUATED BY MFR.: THE COMPLAINT DEVICE WAS RECEIVED FOR ANALYSIS. A VISUAL AND MICROSCOPIC EXAMINATION OF THE DEVICE NOTED PROXIMAL STENT DAMAGE. STRUTS AT THE PROXIMAL EDGE WERE RAISED AND MISALIGNED. NO KINKS OR DAMAGE WERE NOTICED ALONG THE SHAFT OF THE DEVICE. THE BALLOON AND TIP SECTIONS OF THE DEVICE WERE VISUALLY AND MICROSCOPICALLY EXAMINED AND NO ISSUES WERE NOTED 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 CAUSED BY OTHER DEVICE AS IT INDICATES ANOTHER DEVICE/DRUG/SUBSEQUENT PROCEDURE CAUSE THE COMPLAINT EVENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, WITHDRAWAL DIFFICULTIES AND STENT DAMAGE OCCURRED. THE PROCEDURE TREATED THE 90% STENOSED TARGET LESION LOCATED IN THE NON-CALCIFIED AND MODERATELY TORTUOUS PROXIMAL TO MID RIGHT CORONARY ARTERY. AFTER PRE-DILATION WITH AN UNSPECIFIED 2.0MM BALLOON CATHETER, A 3.0X38MM PROMUS ELEMENT PLUS STENT WAS ADVANCED FOR TREATMENT BUT MET RESISTANCE WHEN TRYING TO CROSS THE LESION. WHILE THE PHYSICIAN WAS PUSHING, THE NON-BSC GUIDE CATHETER DISENGAGED FROM THE VESSEL. WHEN THE PHYSICIAN WAS TRYING TO RE-POSITION THE GUIDE CATHETER, THE NON-BSC GUIDE WIRE AND PROMUS ELEMENT PLUS STENT WERE UNINTENTIONALLY WITHDRAWN. NEXT THE PHYSICIAN TRIED TO WITHDRAW THE STENT, BUT THE STENT CAME INTO CONTACT WITH THE GUIDE CATHETER AND WAS UNABLE TO BE WITHDRAWN. THE PHYSICIAN THEN WITHDREW THE ENTIRE SYSTEM. UPON REMOVAL, IT WAS NOTED THAT THE PROXIMAL EDGE OF THE STENT HAD LIFTED. THE PROCEDURE WAS COMPLETED WITH A NON-BSC STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, WITHDRAWAL DIFFICULTIES AND STENT DAMAGE OCCURRED. THE PROCEDURE TREATED THE 90% STENOSED TARGET LESION LOCATED IN THE NON-CALCIFIED AND MODERATELY TORTUOUS PROXIMAL TO MID RIGHT CORONARY ARTERY. AFTER PRE-DILATION WITH AN UNSPECIFIED 2.0MM BALLOON CATHETER, A 3.0X38MM PROMUS ELEMENT PLUS STENT WAS ADVANCED FOR TREATMENT BUT MET RESISTANCE WHEN TRYING TO CROSS THE LESION. WHILE THE PHYSICIAN WAS PUSHING, THE NON-BSC GUIDE CATHETER DISENGAGED FROM THE VESSEL. WHEN THE PHYSICIAN WAS TRYING TO RE-POSITION THE GUIDE CATHETER, THE NON-BSC GUIDE WIRE AND PROMUS ELEMENT PLUS STENT WERE UNINTENTIONALLY WITHDRAWN. NEXT THE PHYSICIAN TRIED TO WITHDRAW THE STENT, BUT THE STENT CAME INTO CONTACT WITH THE GUIDE CATHETER AND WAS UNABLE TO BE WITHDRAWN. THE PHYSICIAN THEN WITHDREW THE ENTIRE SYSTEM. UPON REMOVAL, IT WAS NOTED THAT THE PROXIMAL EDGE OF THE STENT HAD LIFTED. THE PROCEDURE WAS COMPLETED WITH A NON-BSC STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145495 PROMUS ELEMENT? PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493918438300

    Patients

    Seq Age Sex Outcome Treatment
    1 SION GUIDE WIRE| 7F AXESS AL1