BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAFLEX COVERED NG ESOPHAGEAL STENT

    MDR report key: 1002773 · Received February 26, 2008

    Report

    Report Number
    3005099803-2008-00212
    Event Type
    Malfunction
    Date Received
    February 26, 2008
    Date of Event
    November 26, 2007
    Report Date
    January 30, 2008
    Manufacturer
    BOSTON SCIENTIFIC IRELAND, LTD
    Product Code
    ESW
    PMA / PMN Number
    K032910
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE- THE EVENT, AS ORIGINALLY REPORTED, DID NOT INDICATE A REPORTABLE MALFUNCTION; HOWEVER, EVALUATION OF THE RETURNED DEVICE IS CONSISTENT WITH AN MDR-REPORTABLE MALFUNCTION. THIS MANUFACTURER REPORT IS BEING SUBMITTED BASED ON THESE EVALUATION RESULTS. A VISUAL INSPECTION OF THE RETURNED DEVICE REVEALED THAT THE DISTAL STENT LOOPS WERE PARTIALLY DEPLOYED AND THE SUTURE THREAD WAS BROKEN. A FUNCTIONAL EVALUATION INDICATED THAT WHILE IT WAS POSSIBLE TO DEPLOY THE REMAINDER OF THE STENT, SOME INITIAL RESISTANCE WAS ENCOUNTERED. THE CAUSE OF THE SUTURE BREAK IS UNK. A REVIEW OF THE DEVICE HISTORY RECORD FOR THE PERTINENT LOT WAS PERFORMED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO ADDITIONAL COMPLAINTS WERE REPORTED FOR THE LOT. THE DECEMBER 2007 15-MONTH ULTRAFLEX ESOPHAGEAL STENT PRODUCT FAMILY COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO UNFAVORABLE TREND WAS NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORP THAT AN ULTRAFLEX COVERED NG ESOPHAGEAL STENT WAS USED IN A STENT PLACEMENT PROCEDURE ON A PT IN 2007. ACCORDING TO THE COMPLAINANT, THE "PHYSICIAN STARTE[D] TO OPEN THE STENT BY PULLING THE SUTURE, [THE] FIRST KNOTS COULD BE OPENED, TH[EN THE SUTURE THREAD STUCK, AND THE PHYSICIAN] TRIED TO PULL WITH MORE POWER, [AND THE] SUTURE [BROKE]." THE PHYSICIAN REMOVED THE STENT AND SUCCESSFULLY COMPLETED THE PROCEDURE WITH ANOTHER STENT (DEVICE AND MANUFACTURER UNK). AT THE CONCLUSION OF THE PROCEDURE, THE PT'S CONDITION WAS REPORTED AS "GOOD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAFLEX COVERED NG ESOPHAGEAL STENT ESW BOSTON SCIENTIFIC IRELAND, LTD M00514200 11129942

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR