BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT¿ PLUS

    MDR report key: 3111855 · Received May 14, 2013

    Report

    Report Number
    2134265-2013-03029
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    February 20, 2013
    Report Date
    April 15, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. (B)(4). DEVICE EVALUATION: THE DEVICE WAS RETURNED IN TWO PIECES AS RESULT OF A BREAK 4 MM DISTAL TO THE EXIT PORT OF THE DEVICE. A KINK WAS NOTED 100 MM PROXIMAL TO THE EXIT PORT. THE DISTAL SECTION OF THE DEVICE WAS RETURNED WITH A 0.014 INCH GUIDEWIRE STILL INSIDE. THE STENT HAD DISLODGED FROM THE BALLOON AND WAS SITTING JUST PAST THE BALLOON SECTION ON THE PROXIMAL END OF THE SHAFT. VISUAL AND MICROSCOPIC EXAMINATION REVEALED THE STENT WAS STRETCHED ALONG ITS LENGTH CAUSING SOME STRUTS ALONG THE STENT TO BE RAISED UP. 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 DISTAL END OF THE BALLOON WAS PARTIALLY INFLATED AND WAS NOT SUBJECTED TO POSITIVE PRESSURE. SEVERAL SMALL KINKS WERE NOTED ALONG THE LUMEN JUST PROXIMAL TO THE BALLOON SECTION. VISUAL EXAMINATION OF THE TIP REVEALED THE TIP WAS DAMAGED AND IT WAS FOUND THE GUIDEWIRE WAS STUCK INSIDE THE TIP. SOME RESISTANCE WAS ENCOUNTERED UPON REMOVING THE GUIDEWIRE FROM THE DEVICE AND THIS RESISTANCE WAS CAUSING THE LUMEN TO BECOME KINKED. THE HYPOTUBE WAS KINKED AT 160 MM AND 990 MM AND SEVERAL SMALLER KINKS WERE ALSO NOTED ALONG THE HYPOTUBE. 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 CONSIDERED HANDLING DAMAGE AS THE EVENT OCCURRED PRIOR TO PATIENT CONTACT. (B)(4).

    Description of Event or Problem · 1

    REPORTABLE BASED ON THE PRODUCT ANALYSIS COMPLETED ON (B)(6) 2013. IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE, THE STENT DELIVERY SYSTEM WAS GOT STUCK ON THE GUIDEWIRE OUTSIDE THE BODY. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. THE PHYSICIAN ATTEMPTED TO INTRODUCE A 2.75X28MM PROMUS ELEMENT STENT INTO THE PATIENT, BUT THE STENT DELIVERY SYSTEM GOT STUCK ON AN UNSPECIFIED NON-BSC GUIDEWIRE AND WAS UNABLE TO BE ADVANCED INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER 2.75X28MM PROMUS ELEMENT STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE. HOWEVER, THE PRODUCT ANALYSIS ON THE RETURNED DEVICE REVEALED THAT THE STENT WAS DAMAGED AND DISLODGED FROM THE BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212031 PROMUS ELEMENT¿ PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911428270 15535301

    Patients

    Seq Age Sex Outcome Treatment
    1