BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT¿ PLUS

    MDR report key: 2993477 · Received March 7, 2013

    Report

    Report Number
    2134265-2013-01253
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    February 8, 2013
    Report Date
    February 11, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE A FAILURE ANALYSIS OF THE DEVICE COULD NOT BE COMPLETED. 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 PRIOR TO A STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED THE TARGET LESION WAS LOCATED IN THE MIDDLE LEFT ANTERIOR DESCENDING (LAD) ARTERY. WHILE REMOVING THE 2.25 X 12 MM PROMUS ELEMENT PLUS STENT SYSTEM FROM THE PACKAGE, THE STENT WAS CRINKLED. THE DEVICE NEVER ENTERED THE PATIENT AND THE DEVICE WAS NOT USED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97949 PROMUS ELEMENT¿ PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911412220 15689423

    Patients

    Seq Age Sex Outcome Treatment
    1