BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT? PLUS

    MDR report key: 3111931 · Received May 14, 2013

    Report

    Report Number
    2134265-2013-03086
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    April 14, 2013
    Report Date
    April 15, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: A VISUAL AND MICROSCOPIC EXAMINATION IDENTIFIED DISTAL STENT DAMAGE. THE STRUTS ON THE FIRST TWO TO THREE ROWS ON THE DISTAL END OF THE STENT WERE PUSHED INTO BODY OF THE STENT CAUSING THE STENT TO HAVE MOVED BACK PROXIMALLY BY 3MM AND AS RESULT SOME STRUTS WERE MISALIGNED. 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. THE BALLOON AND THE TIP OF THE DEVICE WERE VISUALLY AND MICROSCOPICALLY EXAMINED AND NO ISSUES WERE NOTED WITH THEIR PROFILE THAT COULD HAVE POTENTIALLY CONTRIBUTED TO THE COMPLAINT INCIDENT. THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO POSITIVE PRESSURE. NO KINKS OR DAMAGE WERE NOTICED ALONG THE SHAFT OF THE DEVICE. SOLIDIFIED CONTRAST MEDIA WAS PRESENT WITHIN THE ENTIRE LENGTH OF THE INFLATION LUMEN, THEREFORE INDICATING THE DEVICE HAD BEEN PREPPED FOR USE. NO OTHER ISSUES WERE NOTED WITH THE DEVICE. 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).

    Description of Event or Problem · 1

    SAME CASE AS MDR 2134265-2013-03131. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. THE LESION BEING TREATED WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. THE PHYSICIAN ADVANCED A 2.50X16MM PROMUS ELEMENT PLUS STENT DELIVERY SYSTEM (SDS) THROUGH A GUIDEZILLA EXTENSION GUIDE CATHETER. HOWEVER THE STENT GOT CAUGHT ON THE PROXIMAL COLLAR OF THE CATHETER. THE SDS WAS SUCCESSFULLY REMOVED AND IT WAS NOTED THAT STENT DAMAGE HAD OCCURRED. THE PHYSICIAN ADVANCED A SECOND 2.50X16MM PROMUS ELEMENT PLUS (SDS) THROUGH THE SAME GUIDE CATHETER AND IT ALSO GOT CAUGHT ON THE PROXIMAL COLLAR OF THE CATHETER. THE DEVICES WERE SUCCESSFULLY REMOVED AND IT WAS NOTED THAT STENT DAMAGE HAD OCCURRED. THE PROCEDURE WAS COMPLETED BY IMPLANTING ANOTHER STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS IS FINE.

    Description of Event or Problem · 1

    SAME CASE AS MDR 2134265-2013-03131. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. THE LESION BEING TREATED WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. THE PHYSICIAN ADVANCED A 2.50X16MM PROMUS ELEMENT PLUS STENT DELIVERY SYSTEM (SDS) THROUGH A GUIDEZILLA EXTENSION GUIDE CATHETER. HOWEVER THE STENT GOT CAUGHT ON THE PROXIMAL COLLAR OF THE CATHETER. THE SDS WAS SUCCESSFULLY REMOVED AND IT WAS NOTED THAT STENT DAMAGE HAD OCCURRED. THE PHYSICIAN ADVANCED A SECOND 2.50X16MM PROMUS ELEMENT PLUS (SDS) THROUGH THE SAME GUIDE CATHETER AND IT ALSO GOT CAUGHT ON THE PROXIMAL COLLAR OF THE CATHETER. THE DEVICES WERE SUCCESSFULLY REMOVED AND IT WAS NOTED THAT STENT DAMAGE HAD OCCURRED. THE PROCEDURE WAS COMPLETED BY IMPLANTING ANOTHER STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT¿S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211766 PROMUS ELEMENT? PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911416250 0015854167

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR