BEUDAMED
    FDA Adverse Event Death Summary report: N

    WALLFLEX ENTERAL COLONIC STENT WITH ANCHOR LOCK DELIVERY SYSTEM

    MDR report key: 1738967 · Received June 28, 2010

    Report

    Report Number
    3005099803-2010-00241
    Event Type
    Death
    Date Received
    June 28, 2010
    Date of Event
    June 15, 2008
    Report Date
    May 22, 2009
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    MQR
    PMA / PMN Number
    K061877
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (6) . (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 DUE TO MALIGNANT NEOPLASM, PERFORMED ON (B) (6) 2007. ACCORDING TO THE COMPLAINANT, 334 DAYS POST STENT PLACEMENT, THE PATIENT DIED. THE CAUSE OF DEATH WAS REPORTED AS "NOT COLORECTAL CANCER RELATED". THE PHYSICIAN REPORTED THAT THE PATIENT WAS NOT SEEN AT THE HOSPITAL AFTER DISCHARGE FOR STENT PLACEMENT, THE DEATH DID NOT OCCUR AT THE HOSPITAL, AND THE ONLY INFORMATION AVAILABLE WAS PROVIDED BY THE PATIENT'S FAMILY. HE STATED THAT "IT IS CLEAR THAT THE DEATH IS NOT RELATED WITH THE PROSTHESIS AND THAT THE CAUSE OF DEATH WAS NOT PROGRESSION OF THE DISEASE, BUT WE CANNOT SAY THE EXACT CAUSE OF DEATH."

    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 DUE TO MALIGNANT NEOPLASM, PERFORMED ON (B) (6) 2007. ACCORDING TO THE COMPLAINANT, 334 DAYS POST STENT PLACEMENT, THE PATIENT DIED. THE CAUSE OF DEATH WAS REPORTED AS "NOT COLORECTAL CANCER RELATED". THE PHYSICIAN REPORTED THAT THE PATIENT WAS NOT SEEN AT THE HOSPITAL AFTER DISCHARGE FOR STENT PLACEMENT, THE DEATH DID NOT OCCUR AT THE HOSPITAL, AND THE ONLY INFORMATION AVAILABLE WAS PROVIDED BY THE PATIENT'S FAMILY. HE STATED THAT "IT IS CLEAR THAT THE DEATH IS NOT RELATED WITH THE PROSTHESIS AND THAT THE CAUSE OF DEATH WAS NOT PROGRESSION OF THE DISEASE, BUT WE CANNOT SAY THE EXACT CAUSE OF DEATH."

    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 9734808

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death