BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYFLEX ESOPHAGEAL STENT

    MDR report key: 837942 · Received April 11, 2007

    Report

    Report Number
    6000146-2007-00009
    Event Type
    Injury
    Date Received
    April 11, 2007
    Date of Event
    March 20, 2007
    Report Date
    March 20, 2007
    Manufacturer
    RUSCH GMBH GERMANY / TELEFLEX MEDICAL
    Product Code
    ESW
    PMA / PMN Number
    K030559
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN REC'D BY THIS MFR. AN EVAL HAS NOT BEEN PERFORMED; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT. THE 02/2007, 15-MONTH TREND REPORT FOR THIS PRODUCT FAMILY, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO ADVERSE TRENDS WERE NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORP IN 2007 THAT AFTER THE PLACEMENT OF A POLYFLEX ESOPHAGEAL STENT ON A MALE, "THE STENT FOLDED AND, UPON AN ATTEMPT TO REPOSITION IT, THE MESH OF THE STENT GOT BROKEN". AFTER THE DEPLOYMENT OF THE STENT, THE PHYSICIAN "FOUND A FOLD AT THE PROXIMAL PART OF THE STENT AND THE STENT WAS PLACED BELOW THE FISTULA". AS THE PHYSICIAN ATTEMPTED TO "PULL THE STENT WITH (A) RAT TOOTH FORCEP SO AS TO COVER THE FISTULA, THE MESH OF THE STENT GOT BROKEN". THE STENT WAS PLACED SUCCESSFULLY OVER THE FISTULA. "DUE TO THE BROKEN MESHES, THE PT STARTED COMPLAINING ABOUT RETRO-STERNAL PAIN AND BREATHING PROBLEM(S)." THE PT'S CONDITION GOT WORSE AFTER 15-20 MINS; THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE STENT. THE PT'S CONDITION WAS REPORTED AS "NORMAL".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLYFLEX ESOPHAGEAL STENT ESW ESW RUSCH GMBH GERMANY / TELEFLEX MEDICAL M00514300 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention