BEUDAMED
    FDA Adverse Event Death Summary report: N

    WALLFLEX ¿ DUODENAL

    MDR report key: 2276032 · Received October 5, 2011

    Report

    Report Number
    3005099803-2011-03355
    Event Type
    Death
    Date Received
    October 5, 2011
    Date of Event
    September 4, 2011
    Report Date
    September 10, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    MUM
    PMA / PMN Number
    K062750
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO REPORT THE LOT NUMBER; THEREFORE THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. A VISUAL AND FUNCTIONAL EXAMINATION OF THE COMPLAINT DEVICE COULD NOT BE PERFORMED SINCE THE DEVICE REMAINS IMPLANTED, AND WAS NOT RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD (DHR) AND A REVIEW OF SIMILAR COMPLAINTS COULD NOT BE PERFORMED AS THE DEVICE UPN AND LOT NUMBER IS UNKNOWN. A LABELING REVIEW WAS PERFORMED, AND FROM THE INFORMATION AVAILABLE THIS DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL. PERFORATION AND DEATH ARE LISTED IN THE DFU FOR THIS PRODUCT AS POTENTIAL POST-STENT PLACEMENT COMPLICATIONS ASSOCIATED WITH THE USE OF THIS DEVICE. THEREFORE, 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 DUODENAL STENT WAS PLACED WITHIN A PATIENT'S DUODENUM IN ORDER TO TREAT A STENOSIS ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, AFTER THE STENT WAS IMPLANTED "THE PATIENT EXPIRED DUE TO PERFORATION". DESPITE NUMEROUS ATTEMPTS BOSTON SCIENTIFIC HAS BEEN UNABLE OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL DUODENAL STENT WAS PLACED WITHIN A PATIENT'S DUODENUM IN ORDER TO TREAT A STENOSIS ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, AFTER THE STENT WAS IMPLANTED THE PATIENT EXPIRED DUE TO PERFORATION. DESPITE NUMEROUS ATTEMPTS BOSTON SCIENTIFIC HAS BEEN UNABLE OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED. *** SINCE (B)(6), 2011, THE FOLLOWING NEW INFORMATION WAS RECEIVED. *** IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL DUODENAL STENT WAS IMPLANTED WITHIN A DUODENAL STENOSIS OF A CANCER PATIENT, ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, THE PATIENT UNDERWENT CHEMO-RADIATION THERAPY (CRT) FOR TREATMENT OF PANCREATIC CANCER ON (B)(6), 2011. AFTER CRT, THE STENT WAS IMPLANTED AGAINST THE STENOSIS FROM THE DESCENDING PART OF THE DUODENUM UNTIL THE INFERIOR THIRD PART OF THE DUODENUM. REPORTEDLY, AFTER THE STENT WAS IMPLANTED, THE STENT EDGE WAS SEEN AT BELLY SIDE. THREE DAYS LATER, THE STENT EDGE WAS IN THE INFERIOR FLEXURE OF THE DUODENUM. POST PROCEDURE, THE PATIENT PRESENTED WITH ABDOMINAL PAIN AND INCREASED C-REACTIVE PROTEIN. A COMPUTED TOMOGRAPHY (CT) SCAN AND RADIOGRAPHIC IMAGING CONFIRMED THAT THE PATIENT HAD A PERFORATION AROUND THE INFERIOR FLEXURE OF THE DUODENUM. THE PHYSICIAN THOUGHT THAT THE PERFORATION WAS CAUSED BY THE CONTACT BETWEEN THE STENT EDGE AND INFERIOR FLEXURE OF THE DUODENUM. HOWEVER, THE PHYSICIAN ALSO STATED THAT THE PATIENT HAD DECREASED HEALING TIME, IN SUCH IT WOULD BE EASY FOR THE TISSUE TO SPLIT DUE TO SCARRING, AS A RESULT OF THE CRT. THE RESTORATIVE CAPACITY OF THE PATIENT TISSUE WAS LOW, THUS, THE RISK OF PERFORATION WAS HIGH. ON (B)(6), 2011, ONE HUNDRED AND FOURTEEN DAYS POST STENT PLACEMENT, THE PATIENT EXPIRED DUE TO THE PERFORATION OF THE INFERIOR FLEXURE OF THE DUODENUM. AN AUTOPSY WAS NOT PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLFLEX ¿ DUODENAL STENT,METALLIC,EXPANDABLE,DUODENAL MUM BOSTON SCIENTIFIC - GALWAY M00565020

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death