BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLFLEX PARTIALLY COVERED ESOPHAGEAL STENT SYSTEM

    MDR report key: 2139825 · Received June 25, 2011

    Report

    Report Number
    3005099803-2011-02166
    Event Type
    Injury
    Date Received
    June 25, 2011
    Report Date
    June 1, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    ESW
    PMA / PMN Number
    K073266
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE EXACT EVENT DATE IS UNKNOWN, IT WAS REPORTED THAT THE ISSUE WAS DETECTED TOWARDS THE END OF (B)(6) 2011. THE COMPLAINANT INDICATED THAT THE DEVICE WAS IMPLANTED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    (B)(4): A VISUAL AND FUNCTIONAL EXAMINATION OF THE COMPLAINT DEVICE COULD NOT BE PERFORMED SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A LABELING REVIEW WAS PERFORMED AND, FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL. IT IS NOTED THAT TUMOR INGROWTH THROUGH THE UNCOVERED PORTION OF THE STENT, TUMOR OVERGROWTH AROUND THE STENT ENDS, AND STENT MIGRATION ARE LISTED AS ADVERSE EVENTS ASSOCIATED WITH ESOPHAGEAL STENT PLACEMENT AS PER THE DFU. THEREFORE, THE MOST PROBABLE ROOT CAUSE CLASSIFICATION IS "ANTICIPATED PROCEDURAL COMPLICATION."

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX PARTIALLY COVERED ESOPHAGEAL STENT WAS IMPLANTED DURING A STENT PLACEMENT PROCEDURE ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, THE INITIAL STENT PLACEMENT WAS COMPLETED SUCCESSFULLY TO TREAT A TUMOR IN THE GASTROESOPHAGEAL JUNCTION (OEG JUNCTION). AT THE END OF (B)(6) 2011, AT A DIFFERENT FACILITY, THE PATIENT COMPLAINED OF DISCOMFORT AND IT WAS NOTED THAT TUMOR INGROWTH WAS PRESENT AT BOTH ENDS OF THE STENT. ON (B)(6), 2011, A NON-BSC STENT WAS IMPLANTED THROUGH THE WALLFLEX STENT TO RESTORE PATENCY OF THE STRICTURE. AT A LATER DATE, THIS NON-BSC STENT MIGRATED. AS A RESULT, ON (B)(6), 2011 A SECOND NON-BSC STENT WAS PLACED INSIDE THE WALLFLEX. THERE ARE REPORTS THAT THIS STENT MIGRATED AS WELL. HOWEVER, IT WAS CONFIRMED THAT THE WALLFLEX STENT REMAINED IMPLANTED AND IN THE CORRECT POSITION. THIS EVENT WAS MENTIONED BY THE COMPLAINANT IN CONVERSATION WITH THE SALES REP AND THE COMPLAINANT FEELS STRONGLY THAT THERE WAS NO ISSUE WITH THE WALLFLEX STENT. THE PATIENT'S CONDITION WAS REPORTED TO BE SATISFACTORY, BUT PENDING INTERVENTION TO REMOVE THE NON-BSC STENTS THAT MIGRATED. AS THE COMPLAINANT FEELS THERE IS NO ISSUE WITH THE WALLFLEX, NO FURTHER INFORMATION APPEARS FORTHCOMING. CORRECTION: UPON FURTHER REVIEW OF THE INFORMATION AVAILABLE, IT IS NOT CLEAR WHETHER THE WALLFLEX STENT MIGRATED IN ADDITION TO THE NON-BSC STENTS OR WHETHER THE STENT REMAINED IMPLANTED IN THE CORRECT POSITION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX PARTIALLY COVERED ESOPHAGEAL STENT WAS IMPLANTED DURING A STENT PLACEMENT PROCEDURE ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, THE INITIAL STENT PLACEMENT WAS COMPLETED SUCCESSFULLY TO TREAT A TUMOR IN THE GASTROESOPHAGEAL JUNCTION (OEG JUNCTION). AT THE (B)(6) 2011, AT A DIFFERENT FACILITY, THE PATIENT COMPLAINED OF DISCOMFORT AND IT WAS NOTED THAT TUMOR INGROWTH WAS PRESENT AT BOTH ENDS OF THE STENT. ON (B)(6), 2011, A NON-BSC STENT WAS IMPLANTED THROUGH THE WALLFLEX STENT TO RESTORE PATENCY OF THE STRICTURE. AT A LATER DATE, THIS NON-BSC STENT MIGRATED. AS A RESULT, ON (B)(6), 2011 A SECOND NON-BSC STENT WAS PLACED INSIDE THE WALLFLEX. THERE ARE REPORTS THAT THIS STENT MIGRATED AS WELL. HOWEVER, IT WAS CONFIRMED THAT THE WALLFLEX STENT REMAINED IMPLANTED AND IN THE CORRECT POSITION. THIS EVENT WAS MENTIONED BY THE COMPLAINANT IN CONVERSATION WITH THE SALES REP AND THE COMPLAINANT FEELS STRONGLY THAT THERE WAS NO ISSUE WITH THE WALLFLEX STENT. THE PATIENT'S CONDITION WAS REPORTED TO BE SATISFACTORY, BUT PENDING INTERVENTION TO REMOVE THE NON-BSC STENTS THAT MIGRATED. AS THE COMPLAINANT FEELS THERE IS NO ISSUE WITH THE WALLFLEX, NO FURTHER INFORMATION APPEARS FORTHCOMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLFLEX PARTIALLY COVERED ESOPHAGEAL STENT SYSTEM PROSTHESIS, ESOPHAGEAL ESW BOSTON SCIENTIFIC - GALWAY M00516900

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Required Intervention