BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT? PLUS

    MDR report key: 3073278 · Received April 23, 2013

    Report

    Report Number
    2134265-2013-02498
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    March 23, 2013
    Report Date
    March 25, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: A VISUAL AND MICROSCOPIC EXAMINATION IDENTIFIED A SHAFT HYPOTUBE BREAK LOCATED 22.5CM FROM THE CATHETER STRAIN RELIEF. A VISUAL AND MICROSCOPIC EXAMINATION ALSO IDENTIFIED KINKS ALONG THE ENTIRE LENGTH OF THE HYPOTUBE. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED TO THE DELIVERY SYSTEM. THE STENT WAS ALSO DAMAGED. THE BALLOON AND TIP SECTIONS OF THE DEVICE WERE VISUALLY AND MICROSCOPICALLY EXAMINED AND NO ISSUES WERE NOTED WITH THEIR PROFILES. 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

    IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE, A SHAFT BREAK OCCURRED. THE LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND SEVERELY TORTUOUS PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 2.50MM X 24MM PROMUS ELEMENT PLUS STENT WAS SELECTED FOR TREATMENT. WHILE ATTEMPTING TO CROSS THE LESION, THE SHAFT OF THE CATHETER SNAPPED AT THE PROXIMAL END. THE DEVICE WAS REMOVED. THE PHYSICIAN ATTEMPTED TO CROSS THE LESION WITH OTHER DEVICES, HOWEVER, THIS WAS UNSUCCESSFUL. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE, A SHAFT BREAK OCCURRED. THE LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND SEVERELY TORTUOUS PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 2.50MM X 24MM PROMUS ELEMENT PLUS STENT WAS SELECTED FOR TREATMENT. WHILE ATTEMPTING TO CROSS THE LESION, THE SHAFT OF THE CATHETER SNAPPED AT THE PROXIMAL END. THE DEVICE WAS REMOVED. THE PHYSICIAN ATTEMPTED TO CROSS THE LESION WITH OTHER DEVICES, HOWEVER, THIS WAS UNSUCCESSFUL. . NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173929 PROMUS ELEMENT? PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911424250 15651558

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR