BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLFLEX ENTERAL DUODENAL STENT WITH ANCHOR LOCK DELIVERY SYSTEM, MOD M00565010

    MDR report key: 2141271 · Received June 27, 2011

    Report

    Report Number
    3005099803-2011-02167
    Event Type
    Injury
    Date Received
    June 27, 2011
    Report Date
    June 2, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    MUM
    PMA / PMN Number
    K062750
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE EXACT PATIENT AGE IS UNKNOWN, THE PATIENT WAS REPORTED TO BE OVER 18 YEARS OF AGE. ALTHOUGH THE EXACT EVENT DATE IS UNKNOWN, THE STENT MIGRATION WAS DETECTED (B)(6), 2011. ALTHOUGH THE EXACT IMPLANTATION DATE IS UNKNOWN, THE STENT WAS IMPLANTED WITHIN (B)(6) 2011. ALTHOUGH THE EXACT EXPLANTATION DATE IS UNKNOWN, THE STENT WAS EXPLANTED (B)(6), 2011. THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL DUODENAL STENT WAS IMPLANTED DURING A STENTING PROCEDURE IN (B)(6) 2011. ACCORDING TO THE COMPLAINANT, THE PATIENT HAD A STRICTURE WITHIN THE DUODENUM DUE TO STOMACH CANCER. THE STRICTURE WAS APPROXIMATELY 3-4CM IN LENGTH AND LOCATED FROM THE PYLORUS INTO THE DUODENUM. THE STENT WAS SUCCESSFULLY IMPLANTED FROM THE PYLORUS INTO THE SECOND PORTION OF THE DUODENUM WITH NO COMPLICATIONS. FOLLOWING THE PROCEDURE (DATE UNKNOWN), AN MRI REVEALED THAT THE STENT HAD MIGRATED INTO THE THIRD PORTION OF THE DUODENUM. THE PATIENT WAS SCHEDULED FOR AN ADDITIONAL PROCEDURE TO REMOVE THE STENT. THE STENT WAS REMOVED SUCCESSFULLY AND NO FURTHER MEDICAL INTERVENTION WAS REQUIRED. THE PHYSICIAN ATTRIBUTED THE STENT MIGRATION TO BOTH THE RADIATION THERAPY AND ANTI-CANCER DRUGS ADMINISTERED TO THE PATIENT. FOLLOWING THE PROCEDURE, IT WAS NOTED THAT THE "PATIENT IS GETTING BETTER" AND THE PATIENT CONDITION WAS REPORTED TO BE "GOOD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLFLEX ENTERAL DUODENAL STENT WITH ANCHOR LOCK DELIVERY SYSTEM, MOD M00565010 STENT,METALLIC,EXPANDABLE,DUODENAL MUM BOSTON SCIENTIFIC - GALWAY M00565020

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention