BEUDAMED
    FDA Adverse Event Death Summary report: N

    WALLFLEX ENTERAL COLONIC STENT

    MDR report key: 1324160 · Received February 25, 2009

    Report

    Report Number
    3005099803-2008-01691
    Event Type
    Death
    Date Received
    February 25, 2009
    Date of Event
    March 21, 2007
    Report Date
    July 17, 2007
    Manufacturer
    BOSTON SCIENTIFIC IRELAND LTD.
    Product Code
    MQR
    PMA / PMN Number
    K042065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE OF THIS EVENT IS UNDETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED ON THE PERTINENT LOT; NO ANOMALIES WERE NOTED.

    Description of Event or Problem · 1

    NOTE: THIS EVENT WAS REPORTED IN MANUFACTURER REPORTS 6000050-2007-00095 AND 6000050-2007-00094, SUBMITTED ON AUGUST 16, 2007. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JULY 17, 2007 THAT A WALLFLEX ENTERAL COLONIC STENT WAS USED IN A PROCEDURE TO TREAT COLONIC STRICTURE (FEMALE PATIENT). ACCORDING TO THE COMPLAINANT, THE INITIAL WALLFLEX ENTERAL COLONIC STENT (9 CM, LOT #9412747; PLACED ON APPROX SIX MONTHS PRIOR) WAS POORLY POSITIONED (TOO LOW), SO THE PHYSICIAN DEPLOYED A SECOND WALLFLEX ENTERAL COLONIC STENT (6 CM, LOT #9371301; OVERLAPPING THE FIRST). THERE WERE NO PATIENT COMPLICATIONS REPORTED DURING THE PROCEDURE OR WITHIN 6 HOURS POST-PROCEDURE, AND NO ANOMALIES WERE DETECTED DURING A POST-PROCEDURE CAT SCAN. A FOLLOW UP CAT SCAN TWO DAYS LATER, REVEALED THAT "THE CATHETER OF THE SECOND [STENT] PASSED THROUGH THE CELLS OF THE FIRST [STENT] DURING INSERTION." THE PHYSICIAN REMOVED THE OVERLAPPED WALLFLEX ENTERAL COLONIC STENT AND DEPLOYED ANOTHER WALLFLEX ENTERAL COLONIC STENT. THE PATIENT PRESENTED SIX DAYS LATER, WITH CONSTIPATION, DIARRHEA, ABDOMINAL PAIN AND BLOATING, AND WAS ADMITTED. THE PHYSICIAN DIAGNOSED "OCCLUSION." BASED ON THE INFORMATION FROM THE COMPLAINANT, IT IS UNKNOWN IF THE DEVICE CAUSED, OR CONTRIBUTED TO, THE OCCLUSION. THE PHYSICIAN THEN DIAGNOSED A PERFORATION TWO DAYS LATER, THOUGH HE "HAD NO ADDITIONAL INFORMATION ON THE LOCATION OF THE PERFORATION" IN RELATION TO THE STENTS (SEE RELATED MEDWATCH 6000050-2007-00094). THE PHYSICIAN NOTED THAT IT MIGHT HAVE OCCURRED IN A DIFFERENT PORTION OF THE BOWEL. ACCORDING TO THE PHYSICIAN, THE PATIENT DIED OF "COLO-RECTAL CANCER-RELATED" CAUSES THREE DAYS LATER. AN AUTOPSY WAS NOT PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLFLEX ENTERAL COLONIC STENT STENT, COLONIC, METALIC, EXPANDABLE MQR BOSTON SCIENTIFIC IRELAND LTD. M00565050 9412747

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death