BEUDAMED
    FDA Adverse Event Death Summary report: N

    WALLFLEX ENTERAL COLONIC STENT WITH ANCHOR LOCK DELIVERY SYSTEM

    MDR report key: 1739001 · Received June 28, 2010

    Report

    Report Number
    3005099803-2010-00244
    Event Type
    Death
    Date Received
    June 28, 2010
    Date of Event
    July 18, 2008
    Report Date
    May 22, 2009
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    MQR
    PMA / PMN Number
    K061877
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (6). (B) (4) (MEDICAL INTERVENTION REQUIRED). (B) (4). AS THE UNIT HAS NOT BEEN RETURNED, THE COMPLAINT INVESTIGATION SITE COULD NOT PERFORM A TECHNICAL ANALYSIS. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT. A LABELING REVIEW WAS PERFORMED AND NO ANOMALY WAS FOUND. THE MOST PROBABLE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL COLONIC STENT WAS USED DURING A STENT PLACEMENT PROCEDURE FOR TREATMENT OF A COLORECTAL STRICTURE AT THE RECTUM DUE TO MALIGNANT NEOPLASM, PERFORMED ON (B) (6) 2008. ACCORDING TO THE COMPLAINANT, 80 DAYS POST STENT PLACEMENT, THE PATIENT EXPERIENCED OBSTRUCTION DUE TO FECAL IMPACTION. THE PATIENT UNDERWENT SURGICAL TREATMENT OF ENDOSCOPIC REPERMEABILIZATION. THE PATIENT DIED ON (B) (6) 2008 WITH A REPORTED CAUSE OF DEATH AS SYSTEMIC INFECTION, PROBABLY URINARY RELATED, WITHIN THE CONTEXT OF THE EVOLUTION OF DISSEMINATED NEOPLASIA. THE PATIENT'S DEATH WAS REPORTED AS NOT RELATED TO A COMPLICATION OF THE STENT, BUT DUE TO A COMPLICATION WITH THE DISSEMINATED NEOPLASIA.

    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 11535291

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death| R