BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 1894394 · Received November 9, 2010

    Report

    Report Number
    3005099803-2010-04596
    Event Type
    Injury
    Date Received
    November 9, 2010
    Date of Event
    October 12, 2010
    Report Date
    October 18, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    MUM
    PMA / PMN Number
    K062750
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - STOMACH ACHE, CONSERVATIVE MANAGEMENT. THE COMPLAINANT INDICATED THAT THE DEVICE REMAINS IMPLANTED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT 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 THERE WERE ISSUES INVOLVING TWO WALLFLEX ENTERAL DUODENAL STENTS USED TO TREAT A PATIENT. ACCORDING TO THE COMPLAINANT, A WALLFLEX ENTERAL DUODENAL STENT (THE SUBJECT OF MANUFACTURER REPORT # 3005099803-2010-04597) WAS IMPLANTED WITHIN THE ASCENDING PART OF THE DUODENUM ON AN UNKNOWN DATE. ON (B)(6) 2010, IN-GROWTH WAS OBSERVED IN THE STENT AND A SECOND WALLFLEX ENTERAL DUODENAL STENT WAS IMPLANTED WITHIN THE FIRST STENT. THE PATIENT REMAINED HOSPITALIZED FOR OTHER DISEASES. ON (B)(6) 2010, THE PATIENT COMPLAINED OF A STOMACH ACHE. FREE AIR WAS OBSERVED INSIDE THE PATIENT, AND A PERFORATION WAS NOTED WITHIN THE ASCENDING PART OF THE DUODENUM. IN THE PHYSICIAN'S ASSESSMENT, THE STENT DEVICES CAUSED THE PERFORATION. CONSERVATIVE MANAGEMENT WAS PERFORMED AND NOW THE PHYSICIAN IS TAKING A "WAIT-AND-SEE" APPROACH. ADDITIONAL FOLLOW-UP REPORTED THAT THE PATIENT WAS IN STABLE CONDITION; HOWEVER, IT IS UNCONFIRMED IF THE PERFORATION HAS HEALED. THE STENTS REMAIN IMPLANTED.

    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 M00565030

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention