BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT ?

    MDR report key: 3896695 · Received June 26, 2014

    Report

    Report Number
    2134265-2014-03653
    Event Type
    Malfunction
    Date Received
    June 26, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 31, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    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 EXAMINATION OF THE CRIMPED STENT FOUND THE STENT WAS DAMAGED. THE STENT STRUTS AT THE DISTAL END OF THE STENT WERE DEFORMED AND LIFTED UPWARDS FROM THE STENT PROFILE. THE BALLOON CONES PROFILES WERE REVIEWED AND NO ISSUES WERE NOTED WITH THE OVERALL BALLOON PROFILE. THE BALLOON WINGS WERE TIGHTLY WRAPPED AND EVENLY FOLDED AND WERE NOT SUBJECTED TO POSITIVE PRESSURE. A VISUAL AND TACTILE EXAMINATION FOUND MULTIPLE KINKS ALONG THE PROXIMAL PORTION OF THE HYPOTUBE SHAFT. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED TO THE DELIVERY SYSTEM. A VISUAL AND TACTILE EXAMINATION FOUND NO ISSUES WITH THE PROFILE. 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 18X4.0 MM, ECCENTRIC, DE NOVO, 90% STENOSED TARGET LESION WAS LOCATED IN A MILDLY TORTUOUS AND MILDLY CALCIFIED LEFT ANTERIOR DESCENDING (LAD) ARTERY. PREDILATION WAS PERFORMED WITH AN UNSPECIFIED BALLOON CATHETER. A 4.00X20MM PROMUS ELEMENT STENT WAS SELECTED TO TREAT THE LESION BUT FAILED TO CROSS THE LESION. IT WAS ALSO NOTICED THAT THE STENT EDGE WAS LIFTED ABOUT 1 MM FROM THE DISTAL END. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE 18X4.0 MM, ECCENTRIC, DE NOVO, 90% STENOSED TARGET LESION WAS LOCATED IN A MILDLY TORTUOUS AND MILDLY CALCIFIED LEFT ANTERIOR DESCENDING (LAD) ARTERY. PREDILATION WAS PERFORMED WITH AN UNSPECIFIED BALLOON CATHETER. A 4.00X20MM PROMUS ELEMENT STENT WAS SELECTED TO TREAT THE LESION BUT FAILED TO CROSS THE LESION. IT WAS ALSO NOTICED THAT THE STENT EDGE WAS LIFTED ABOUT 1 MM FROM THE DISTAL END. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373677 PROMUS ELEMENT ? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911320400 16166406

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR