BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLFLEX ENTERAL DUODENAL STENT

    MDR report key: 917632 · Received September 25, 2007

    Report

    Report Number
    6000050-2007-00116
    Event Type
    Injury
    Date Received
    September 25, 2007
    Date of Event
    August 30, 2007
    Report Date
    August 31, 2007
    Manufacturer
    BOSTON SCIENTIFIC CORP
    Product Code
    MUM
    PMA / PMN Number
    K980113
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED, BUT AN EVALUATION HAS NOT YET BEEN PERFORMED; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE AND THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT IS UNDETERMINED. A DEVICE HISTORY RECORD REVIEW AND PRODUCT FAMILY COMPLAINT TREND REVIEW ARE IN PROGRESS; RESULTS WILL BE PROVIDED IN A FOLLOW-UP MEDWATCH REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORP IN 2007, THAT A WALLFLEX ENTERAL DUODENAL STENT WAS USED IN A STENT PLACEMENT PROCEDURE ON A MALE PATIENT (AGE AND WEIGHT UNK) ON THE DAY BEFORE. ACCORDING TO THE COMPLAINANT, "THE WALLFLEX STENT COULD NOT BE RELEASED, HALF OF THE WALLFLEX [WAS] RELEASED. A NEW WALLFLEX WILL BE PLACED." REPORTEDLY, THIS "EVENT PROLONGED [THE PATIENT'S] HOSPITAL STAY." BOSTON SCIENTIFIC CORP HAS MADE NUMEROUS ATTEMPTS TO OBTAIN FURTHER DETAILS; HOWEVER, NO FURTHER INFO ABOUT THE EVENT OR THE PATIENT'S CONDITION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLFLEX ENTERAL DUODENAL STENT MUM BOSTON SCIENTIFIC CORP M00565030 9182128

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization