BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAFLEX COVERED NG ESOPHAGEAL STENT

    MDR report key: 1003320 · Received February 27, 2008

    Report

    Report Number
    3005099803-2008-00219
    Event Type
    Malfunction
    Date Received
    February 27, 2008
    Date of Event
    November 28, 2007
    Report Date
    February 4, 2008
    Manufacturer
    BOSTON SCIENTIFIC IRELAND, LTD.
    Product Code
    ESW
    PMA / PMN Number
    K032910
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE: THE EVENT, AS REPORTED, DID NOT REFLECT AN MDR-REPORTABLE SCENARIO; HOWEVER, EVALUATION OF THE RETURNED DEVICE REVEALED AN MDR-REPORTABLE MALFUNCTION. THIS MANUFACTURER REPORT IS SUBMITTED BASED ON THESE RESULTS. A VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED THAT THE DISTAL SECTION OF THE STENT WAS PARTIALLY DEPLOYED AND HAD FOLDED BACK ON ITSELF. A FUNCTIONAL EVALUATION INDICATED THAT ONCE THE STENT WAS UNFOLDED, IT WAS POSSIBLE TO DEPLOY THE REMAINDER OF THE STENT. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THE PERTINENT LOT; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO ADDITIONAL COMPLAINTS HAVE BEEN REPORTED FOR THE LOT. THE (B)(6) 2007, 15-MONTH ULTRAFLEX ESOPHAGEAL STENTS PRODUCT FAMILY COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO UNFAVORABLE TREND WAS NOTED. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2007, IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX COVERED NG ESOPHAGEAL STENT WAS USED DURING A STENT PLACEMENT PROCEDURE ON (B)(6) MALE PATIENT (WEIGHT UNKNOWN) ON (B)(6) 2007. ACCORDING TO THE COMPLAINANT, "THE STENT DIDN'T OPEN PROPERLY.. (T)HE SUTURE DID NOT [BREAK]...[THE PHYSICIAN] DID NOT RELEASE THE STENT...(AND THE STENT WAS REMOVED ALONG) WITH THE INTRODUCER." THE PROCEDURE WAS NOT COMPLETED AS ANOTHER DEVICE WAS NOT AVAILABLE. THE PATIENT'S CONDITION WAS REPORTED AS "STABLE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAFLEX COVERED NG ESOPHAGEAL STENT ESW BOSTON SCIENTIFIC IRELAND, LTD. M00514200 9344125

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR