BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ?

    MDR report key: 3193122 · Received June 27, 2013

    Report

    Report Number
    2134265-2013-04145
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    April 2, 2013
    Report Date
    May 30, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. (B)(4). THE COMPLAINT DEVICE WAS RECEIVED FOR ANALYSIS. A VISUAL AND MICROSCOPIC EXAMINATION OF THE RETURNED DEVICE NOTED THAT THE STENT WAS DAMAGED. STRUT ROWS ALONG THE LENGTH OF THE STENT WERE RAISED FROM THE BALLOON AND MISALIGNED. THE BALLOON AND TIP SECTIONS 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 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)

    Description of Event or Problem · 1

    SAME CASE AS MDR ID: 2134265-2013-04145. REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(4) 2013. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, THE STENT WOULD NOT CROSS THE LESION. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND SEVERELY TORTUOUS RIGHT CORONARY ARTERY. AFTER PRE-DILATAION WAS PERFORMED USING A 1.5X20 NON-BSC BALLOON CATHETER, A 3.50X32MM PROMUS ELEMENT DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE LESION WAS DILATED AGAIN USING THE SAME BALLOON CATHETER AND ANOTHER 3.50X24MM PROMUS ELEMENT DRUG-ELUTING STENT WAS ADVANCE, BUT FAILED TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A STENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294275 PROMUS ELEMENT ? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911332350 15020591

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR