BEUDAMED
    FDA Adverse Event Death Summary report: N

    JAGWIRE

    MDR report key: 1474683 · Received September 16, 2009

    Report

    Report Number
    3005099803-2009-04404
    Event Type
    Death
    Date Received
    September 16, 2009
    Date of Event
    August 13, 2009
    Report Date
    August 19, 2009
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EZB
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    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.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO COMPLAINTS THAT OCCURRED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT #3005099803-2009-04403 FOR THE OTHER ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL COLONIC STENT AND JAGWIRE GUIDEWIRE WERE USED DURING A COLONOSCOPY WITH COLONIC STENT PLACEMENT PERFORMED IN 2009. ACCORDING TO THE COMPLAINANT, THE PATIENT HAD A LARGE BOWEL OBSTRUCTION DUE TO A FIBROTIC ILEOCOLONIC ANASTOMOTIC STRICTURE. THE PATIENT HAD A HISTORY OF INFLAMMATORY BOWEL DISEASE (IBD) AND HAD UNDERGONE A PREVIOUS SURGERY AT THE STRICTURE SITE. THE PATIENT'S SURGEON HAD MADE A REQUEST TO A GASTROENTEROLOGIST TO PLACE A STENT. THE STENT WAS DEPLOYED SUCCESSFULLY AND EXPANDED WELL DURING THE INITIAL PROCEDURE. A .035" JAGWIRE GUIDEWIRE WAS USED DURING STENT PLACEMENT. THERE WERE NO PROBLEMS OR COMPLICATIONS NOTED POST PROCEDURE. NO DAMAGE WAS NOTED TO THE GUIDEWIRE POST PROCEDURE NOR WAS ANY DAMAGE NOTED TO THE STENT SYSTEM. ONE DAY POST STENT PLACEMENT, THE PATIENT COMPLAINED OF ABDOMINAL PAIN. FROM THE NEXT DAY FOR TWO DAYS, X-RAYS WERE PERFORMED AND REVEALED NO VISIBLE FREE AIR IN THE PATIENT. FOUR DAYS LATER, ANOTHER X-RAY WAS PERFORMED AT WHICH TIME FREE AIR WAS VISIBLE INSIDE THE PATIENT. THE SAME DAY, THE PATIENT WAS TAKEN TO THE OR WHERE AN ABDOMINAL X-RAY REVEALED A PERFORATION AT WHICH TIME A PORTION OF THE ILEOCOLONIC ANASTOMOSIS WAS EXCISED AND THE STENT REMOVED. FOLLOWING REMOVAL OF THE IMPLANTED STENT, NO DAMAGE WAS NOTED TO THE STENT. IT WAS ALSO NOTED THAT THE SITE OF THE ILEOCOLONIC ANASTOMOSIS (WHERE THE STENT WAS ORIGINALLY PLACED), HAD A TRANSMURAL WALL EDEMA AND NECROSIS SUGGESTIVE OF UNDERLYING UNDIAGNOSED IBD. THE ILEAL LOOP WAS DENSELY ADHERENT TO THE RETROPERITONEUM. IT WAS BELIEVED THAT PORTION OF THE ILEUM WAS DISEASED TO BEGIN WITH AND THE STENT CAUSED THE IMPINGEMENT OF THE ILEAL LOOP AGAINST THE DENSE RETROPERITONEUM CAUSING ISCHEMIC NECROSIS OF THAT SEGMENT AND SUBSEQUENT PERFORATION. THE PATIENT SUBSEQUENTLY EXPIRED THREE DAYS LATER. THE LIKELY CAUSE OF DEATH RESULTED FROM PERFORATION OF THE COLON CAUSED BY THE COLONIC STENT RESULTING IN SUBSEQUENT SEPTIC PERITONITIS AND SHOCK. AN AUTOPSY WILL NOT BE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JAGWIRE EZB BOSTON SCIENTIFIC CORPORATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death WALLFLEX ENTERAL COLONIC STENT