BEUDAMED
    FDA Adverse Event Death Summary report: N

    WALLFLEX ENTERAL COLONIC STENT WITH ANCHOR LOCK DELIVERY SYSTEM

    MDR report key: 1705786 · Received June 2, 2010

    Report

    Report Number
    3005099803-2010-02435
    Event Type
    Death
    Date Received
    June 2, 2010
    Date of Event
    May 7, 2010
    Report Date
    May 10, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    MQR
    PMA / PMN Number
    K061877
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (6). 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. 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

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL COLONIC STENT WAS USED DURING A COLONOSCOPY WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B) (6) 2010. ACCORDING TO THE COMPLAINANT, THE STENT WAS BEING PLACED AS PALLIATION FOR A MALIGNANT OBSTRUCTION. THE STENT PROCEDURE AND PLACEMENT WERE REPORTED AS GOING WELL, AND NO ISSUES WERE REPORTED WITH THE STENT. IT WAS STATED THAT THE PATIENT BENEFITED FROM THE STENT PLACEMENT INITIALLY. AFTER THE PROCEDURE, IT WAS REPORTED THAT THE PATIENT HAD A PERFORATION IN THE BOWEL AND DIED THE SAME DAY, ON (B) (6) 2010. THE CAUSE OF DEATH WAS COLONIC WALL PERFORATION. THE COMPLAINANT STATED THAT "THEY DON'T FEEL THAT IT WAS THE STENT BUT MORE THE PROCEDURE". ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLFLEX ENTERAL COLONIC STENT WITH ANCHOR LOCK DELIVERY SYSTEM STENT, COLONIC, METALIC, EXPANDABLE MQR BOSTON SCIENTIFIC - GALWAY M00565050

    Patients

    Seq Age Sex Outcome Treatment
    1 Death