BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ¿

    MDR report key: 2904638 · Received January 9, 2013

    Report

    Report Number
    2134265-2012-08395
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    November 13, 2012
    Report Date
    December 13, 2012
    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). DEVICE EVALUATED BY MANUFACTURER: ANALYSIS OF THE RETURNED DEVICE REVEALED STENT DAMAGE AND HYPOTUBE KINKS. A VISUAL AND MICROSCOPIC EXAMINATION FOUND THAT THE STENT WAS DAMAGED ALONG SEVERAL STRUT ROWS AT THE CENTER. STRUTS ON VARIOUS ROWS ARE BENT OUTWARDS. THE STENT WAS ALSO SLIGHTLY STRETCHED THEREBY PARTLY COVERING THE DISTAL MARKERBAND. THE HYPOTUBE WAS KINKED AT VARIOUS LOCATIONS ALONG ITS LENGTH. THE DISTAL INNER AND OUTER WERE KINKED AND TWISTED JUST PROXIMAL TO THE PROXIMAL BALLOON BOND. NO ISSUES WERE NOTED WITH THE TIP AND BALLOON OF THE DEVICE. THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO POSITIVE PRESSURE. 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

    REPORTABLE BASED ON THE PRODUCT ANALYSIS COMPLETED ON (B)(4) 2012. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE, A NO CROSS OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED RIGHT CORONARY ARTERY. PRE DILATATION WAS PERFORMED WITH THE 3.0 X 15 MM MAVERICK BALLOON CATHETER AND THE 3.5 MM X 28 MM PROMUS ELEMENT STENT DELIVERY SYSTEM WAS ADVANCED TO THE LESION BUT FAILED TO CROSS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS STABLE. HOWEVER, THE RETURNED PRODUCT ANALYSIS REVEALED THAT THERE WAS STENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12216 PROMUS ELEMENT ¿ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911328350 15207976

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR