BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLFLEX ENTERAL COLONIC STENT

    MDR report key: 1153348 · Received September 5, 2008

    Report

    Report Number
    3005099803-2008-04364
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    July 29, 2008
    Report Date
    August 6, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MQR
    PMA / PMN Number
    K042065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    SAME CASE AS MFR REPORT #: 3005099803-2008-04365, -04366. WALLFLEX=ER COLONIC REGISTRY. IT WAS REPORTED THAT 340 DAYS FOLLOWING PLACEMENT OF A WALLFLEX ENTERAL COLONIC STENT, THE PATIENT DEVELOPED A PERFORATION. THE PATIENT WAS TREATED INITIALLY DUE TO AN INTRINSIC TUMOR OF THE SIGMOID COLON CONSISTENT WITH COLO-RECTAL CANCER INCLUDING METASTASES IN THE LIVER. THE PATIENT WAS SELECTED FOR PALLIATIVE TREATMENT USING THE WALLFLEX ENTERAL COLONIC STENT. THE 9CMX25 / 30MM WALLFLEX STENT WAS PLACED IN A MEDIUM TORTUOSITY INTESTINAL SEGMENT. THERE WERE NO COMPLICATIONS DURING STENT PLACEMENT OR WITHIN THE SIX HOURS FOLLOWING THE PROCEDURE. THE PATIENT WAS DISCHARGED FOUR DAYS POST PROCEDURE. THE PATIENT PRESENTED 312 DAYS FOLLOWING THE INITIAL PROCEDURE WITH POOR ABILITY TO PASS STOOL, CONSTIPATION, AND INGROWTH/OVERGROWTH OF THE PATIENT'S TUMOR RESULTING IN RE-OBSTRUCTION OF THE STENT. AT TUMOR RESULTING IN RE-OBSTRUCTION OF THE STENT. AT THAT TIME, TWO ADDITIONAL WALLFLEX ENTERAL COLONIC STENTS WERE PLACED INSIDE THE INITIAL STENT, ONE FROM THE MID POINT UP AND ONE FROM THE MID POINT DOWN. THE PATIENT WAS ASYMPTOMATIC 340 DAYS POST PROCEDURE WHEN A CONTROL CT SCAN SHOWED A PERFORATION. THE PATIENT UNDERWENT SURGICAL REPAIR AND A COLOSTOMY. THE PATIENT IS REPORTED TO BE STABLE. ACCORDING TO THE PHYSICIAN, THE PRIMARY CAUSE OF THE PERFORATION WAS ADVANCING DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLFLEX ENTERAL COLONIC STENT MQR - ENTERAL ENDOPROSTHESIS MQR BOSTON SCIENTIFIC CORPORATION M00565050 9664977

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R