BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ?

    MDR report key: 3843122 · Received June 2, 2014

    Report

    Report Number
    2134265-2014-03025
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 8, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: A VISUAL AND MICROSCOPIC EXAMINATION FOUND NO DEFECTS ON THE BALLOON AND TIP SECTIONS OF THE DEVICE. THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO POSITIVE PRESSURE. THE STENT STRUTS ON THE DISTAL END WERE MISALIGNED, BUNCHED AND STRETCHED. AN EXAMINATION FOUND THAT THERE WERE VARIOUS HYPOTUBE KINKS ALONG THE LENGTH OF THE UNIT, WITH THE MOST EXTREME LOCATED ON THE SHAFT POLYMER EXTRUSION. 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

    IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. A 2.50X16MM PROMUS ELEMENT DRUG-ELUTING STENT WAS SELECTED AND ADVANCED TO TREAT THE TARGET LESION BUT WAS UNABLE TO CROSS. IT WAS THEN NOTICED THAT THE STENT WAS DEFORMED. THE DEVICE WAS THEN REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. A 2.50X16MM PROMUS ELEMENT ¿ DRUG-ELUTING STENT WAS SELECTED AND ADVANCED TO TREAT THE TARGET LESION BUT WAS UNABLE TO CROSS. IT WAS THEN NOTICED THAT THE STENT WAS DEFORMED. THE DEVICE WAS THEN REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321854 PROMUS ELEMENT ? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911320250 15887832

    Patients

    Seq Age Sex Outcome Treatment
    1