BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT¿ PLUS

    MDR report key: 3002066 · Received March 13, 2013

    Report

    Report Number
    2134265-2013-01344
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    December 18, 2012
    Report Date
    February 14, 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. DEVICE EVALUATED BY MANUFACTURER: A VISUAL AND MICROSCOPIC EXAMINATION IDENTIFIED PROXIMAL DAMAGE. STRUTS ON THE FIRST THREE ROWS ON THE PROXIMAL END OF THE STENT WERE BUNCHED TOGETHER AND SOME STRUTS WERE RAISED UP. THE DAMAGE CAUSED THE STENT TO MOVE DISTALLY ON THE BALLOON BY 2MM. THIS DAMAGE IS CONSISTENT WITH THE STENT MEETING RESISTANCE UPON ADVANCEMENT AND/OR WITHDRAWAL. 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. THE HYPOTUBE WAS KINKED AT 157MM AND 200MM DISTAL TO THE STRAIN RELIEF. ANOTHER KINK WAS NOTED IN THE LUMEN 300MM PROXIMAL TO THE EXIT PORT. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED TO THE DELIVERY SYSTEM. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED 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

    COMPLAINT IS REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(4) 2013. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, THE STENT WOULD NOT CROSS THE LESION. THE PROCEDURE TREATED THE 75% STENOSED TARGET LESION LOCATED IN THE MODERATELY TORTUOUS LEFT CIRCUMFLEX ARTERY. THERE WAS NO VESSEL CALCIFICATION. THE PHYSICIAN ADVANCED A 2.25X16MM PROMUS ELEMENT PLUS STENT FOR TREATMENT BUT WAS UNABLE TO CROSS THE LESION. NO PROCEDURE DELAY OR PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS GOOD. HOWEVER, ANALYSIS OF THE RETURNED PRODUCT REVEALED THAT THERE WAS STENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105255 PROMUS ELEMENT¿ PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493918416220 15565643

    Patients

    Seq Age Sex Outcome Treatment
    1