BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLFLEX ENTERAL DUODENAL STENT

    MDR report key: 1181142 · Received September 30, 2008

    Report

    Report Number
    3005099803-2008-04924
    Event Type
    Injury
    Date Received
    September 30, 2008
    Date of Event
    August 29, 2008
    Report Date
    September 1, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MUM
    PMA / PMN Number
    K062750
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFO FROM THE REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST A DUODENAL STENTING TREATMENT PROCEDURE, PT COMPLICATIONS OCCURRED. UNDER FLUOROSCOPY, THE WALLFLEX ENTERAL DUODENAL STENT WAS ADVANCED ACROSS THE OBSTRUCTION IN THE DUODENUM. WHEN THE PHYSICIAN DEPLOYED THE STENT, THE PT COMPLAINED OF PAIN. THE PHYSICIAN LOOKED WITH THE ENDOSCOPE AND X-RAY BUT DID NOT FIND ANYTHING "UNUSUAL". THE PHYSICIAN FELT THAT THE STENT WAS SUCCESSFULLY PLACED AND THE PT WAS TRANSFERRED BACK TO HIS ROOM. ABOUT 1/2 HOUR LATER, THE PHYSICIAN WAS NOTIFIED THAT THE PT'S "BELLY" WAS SWELLING AND THE PT WAS NOT CONSCIOUS. THE PHYSICIAN "DOUBTED" THAT A PERFORATION OF THE INTESTINE HAD OCCURRED. UNDER CT GUIDANCE, THE PHYSICIAN FOUND THAT "AIR" WAS COMING FROM THE LOCATION OF THE NEWLY IMPLANTED STENT. THE PT WAS NOT A SURGICAL CANDIDATE DUE TO HIS POOR CONDITION. THE PT'S VITAL SIGNS BECAME STABLE AFTER 'EMERGENCY TREATMENT" AND THE PT WAS CARED FOR IN THE ICU. NO FURTHER COMPLICATIONS OCCURRED. PT STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLFLEX ENTERAL DUODENAL STENT MUM BOSTON SCIENTIFIC M00565030 11595305

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other