BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLFLEX ENTERAL COLONIC STENT

    MDR report key: 1062510 · Received June 18, 2008

    Report

    Report Number
    3005099803-2008-00765
    Event Type
    Injury
    Date Received
    June 18, 2008
    Report Date
    May 22, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MQR
    PMA / PMN Number
    K042065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IMPLANTED BETWEEN LATE 2004 AND EARLY 2006. DEVICE ANALYSIS: THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; 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 PROD FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS PUBLISHED IN THE ENDOSCOPY 2008 JOURNAL ARTICLE "EARLY CLOSURE OF A MULTICENTER RANDOMIZED CLINICAL TRIAL OF ENDOSCOPIC STENTING VERSES SURGERY FOR STAGE IV LEFT-SIDED COLORECTAL CANCER" BY J.E. VAN HOOFT ET AL THAT FOLLOWING A COLONIC STENTING TREATMENT PROCEDURE, PAIN AND A COLONIC PERFORATION OCCURRED. AN UNSPECIFIED SIZED WALLFLEX ENTERAL STENT WAS IMPLANTED FOR THE TREATMENT OF AN UNSPECIFIED COLONIC LESION. THE DAY AFTER IMPLANT, THE PT DEVELOPED SEVERE PAIN REQUIRING HOSPITALIZATION. NO PERFORATION WAS FOUND AND THE PT'S PAIN LESSENED SPONTANEOUSLY AFTER 6 DAYS. AT AN UNSPECIFIED TIME >30 DAYS AFTER IMPLANT, THE PT EXPERIENCED A COLONIC PERFORATION. THE PT'S OUTCOME WAS UNSPECIFIED PER THE PUBLISHED ARTICLE. THE PT'S CURRENT CONDITION IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLFLEX ENTERAL COLONIC STENT MQR STENT, COLONIC, METALIC EXPANDABLE MQR BOSTON SCIENTIFIC

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other