BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT¿ PLUS

    MDR report key: 3010337 · Received March 19, 2013

    Report

    Report Number
    2134265-2013-01419
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    December 19, 2012
    Report Date
    February 14, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE IS COMBINATION PRODUCT. (B)(4). DEVICE EVALUATED BY MFR: A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND DISTAL STENT STRUT DAMAGE AS THE STRUTS AT THE DISTAL EDGE OF THE STENT WERE ELONGATED DISTALLY. FURTHER REVIEW NOTED THAT THE SHAFT WAS SEVERELY KINKED ALONG ITS ENTIRE LENGTH. NO FURTHER DAMAGE WAS NOTED WHICH COULD HAVE CONTRIBUTED TO THE COMPLAINT INCIDENT. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE CLASSIFICATION OF THIS INVESTIGATION IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(4) 2013. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, THE CATHETER WAS UNABLE TO CROSS THE LESION. THE 2.75 X 16MM PROMUS ELEMENT STENT DELIVERY SYSTEM WAS INTRODUCED TO TREAT AN UNSPECIFIED TARGET LESION BUT WAS UNABLE TO CROSS THE LESION. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE HOWEVER, DEVICE ANALYSIS REVEALED STENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113506 PROMUS ELEMENT¿ PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493918416270 0015278675

    Patients

    Seq Age Sex Outcome Treatment
    1