BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ¿

    MDR report key: 3070824 · Received April 22, 2013

    Report

    Report Number
    2134265-2013-02436
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    February 16, 2013
    Report Date
    March 25, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. (B)(4). DEVICE EVALUATED BY MFR: THE STENT WAS RETURNED DISTALLY DAMAGED. A STRUT ON THE FIRST ROW ON THE DISTAL END OF THE STENT WAS RAISED UP. THIS DAMAGE IS CONSISTENT WITH THE STENT MEETING RESISTANCE UPON ADVANCEMENT. THE BALLOON AND THE TIP 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 ANY POSITIVE PRESSURE. NO KINKS OR DAMAGE WERE NOTICED ALONG THE SHAFT OF THE DEVICE. 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 CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(4) 2013. VASCULAR ACCESS WAS GAINED VIA THE RIGHT FEMORAL ARTERY. THE 90%, 2.5X28MM DE NOVO TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY WITH A SIGNIFICANT BEND BETWEEN 45 TO 90 DEGREES. FOLLOWING PRE-DILATION WHICH REDUCED STENOSIS TO 80%, A PROMUS ELEMENT STENT 2.5X32MM WAS ADVANCED BUT FAILED TO CROSS THE LESION. ANOTHER STENT WAS USED, THAT ALSO FAILED TO CROSS THE LESION. THE PROCEDURE WAS STOPPED. THE PATIENT REMAINED STABLE AND NO COMPLICATION HAS BEEN REPORTED. HOWEVER, PRODUCT ANALYSIS REVEALED A STENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173126 PROMUS ELEMENT ¿ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911332250 0015223112

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR