BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT? PLUS

    MDR report key: 3162311 · Received June 11, 2013

    Report

    Report Number
    2134265-2013-04047
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 17, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: A VISUAL AND MICROSCOPIC EXAMINATION OF THE DEVICE NOTED DISTAL STENT DAMAGE. STRUTS AT THE DISTAL EDGE WERE RAISED AND MISALIGNED. 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. NO KINKS OR DAMAGE WERE NOTICED ALONG THE SHAFT OF 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).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    SAME CASE AS: MDR ID 2134265-2013-04046. IT WAS REPORTED THAT DURING PERCUTANEOUS CORONARY INTERVENTION A STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE "VERY" TORTUOUS CIRCUMFLEX ARTERY WHICH WAS NOTED TO HAVE MULTIPLE PREVIOUSLY IMPLANTED UNKNOWN STENTS. A 2.25 X 20MM PROMUS ELEMENT PLUS STENT DELIVERY SYSTEM WAS ADVANCED, BUT WAS UNABLE TO CROSS THE LESION. AFTER THEY PULLED THE STENT OUT, THEY NOTICED THE STENT WAS DEFORMED, COLLAPSED AND FLARED AT THE END. THEY THEN USED A 2.25 X 16MM PROMUS ELEMENT PLUS STENT DELIVERY SYSTEM BUT STILL COULD NOT ADVANCE AND WHEN THEY REMOVED THE DEVICE IT WAS FLARED. THE PROCEDURE WAS NOT COMPLETED. NO COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

    Description of Event or Problem · 1

    SAME CASE AS: MDR ID 2134265-2013-04046. IT WAS REPORTED THAT DURING PERCUTANEOUS CORONARY INTERVENTION A STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE "VERY" TORTUOUS CIRCUMFLEX ARTERY WHICH WAS NOTED TO HAVE MULTIPLE PREVIOUSLY IMPLANTED UNKNOWN STENTS. A 2.25 X 20MM PROMUS ELEMENT PLUS STENT DELIVERY SYSTEM WAS ADVANCED, BUT WAS UNABLE TO CROSS THE LESION. AFTER THEY PULLED THE STENT OUT, THEY NOTICED THE STENT WAS DEFORMED, COLLAPSED AND FLARED AT THE END. THEY THEN USED A 2.25 X 16MM PROMUS ELEMENT PLUS STENT DELIVERY SYSTEM BUT STILL COULD NOT ADVANCE AND WHEN THEY REMOVED THE DEVICE IT WAS FLARED. THE PROCEDURE WAS NOT COMPLETED. NO COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262351 PROMUS ELEMENT? PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911416220 0015839218

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR