BEUDAMED
    FDA Adverse Event Death Summary report: N

    AXIOS STENT AND DELIVERY SYSTEM

    MDR report key: 4863153 · Received June 16, 2015

    Report

    Report Number
    3008516478-2015-00002
    Event Type
    Death
    Date Received
    June 16, 2015
    Report Date
    May 18, 2015
    Manufacturer
    XLUMENA INC., BOSTON SCIENTIFIC CO
    Product Code
    PCU
    PMA / PMN Number
    K123250
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO REPORT THE LOT NUMBER; THEREFORE, THE MFR DATE AND EXPIRATION DATE ARE UNK. DEVICE COMPONENT CODE (B)(4) RELATES TO DEVICE PROBLEM CODE (B)(4)THE REPORTED EVENT OF STENT OCCLUDED. THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFO IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO XLUMENA INC, A BOSTON SCIENTIFIC CO, THAT AN AXIOS STENT AND DELIVERY SYSTEM WAS IMPLANTED ON (B)(6) 2015. THE PT WAS DOING WELL FOR THE FIRST SEVERAL WEEKS. PT BEGAN TO HAVE SYMPTOMS OF DIZZINESS AND FAINTING AND WAS RE-ADMITTED FOR EVALUATION. HE WAS FOUND TO BE HYPOTENSIVE AND ANEMIC WITH MELENIC STOOLS. AN INITIAL ENDOSCOPY WAS PERFORMED AND THE PSEUDOCYST WAS FOUND TO HAVE ORGANIZED CLOT PRESENT WITH NO ACTIVE BLEEDING. THE PT WAS NOT ON ANY ANTICOAGULANTS. THE PT WAS GIVEN 2-3 UNITS OF PACKED RED BLOOD CELLS AND STABILIZED. OVER THE ENSUING 2 WEEKS THE PT HAD RE-BLEEDING EPISODES AND ANEMIA THAT WAS BEING TREATED WITH INFUSION OF -2 UNITS OF PRBC'S EVERY OTHER DAY FOR A TOTAL OF ABOUT 30+ UNITS OF PRBC'S. MULTIPLE ENDOSCOPIES AND AN ANGIOGRAM WERE DONE DURING THIS TIME TO IDENTIFY THE EXACT SOURCE OF BLEEDING. THE ORIGIN OF THE BLEEDING COULD NOT BE CONFIRMED. THE PT WAS RECOMMENDED FOR SURGERY SINCE IT WAS FELT THAT REMOVING THE AXIOS STENT MAY FURTHER DISRUPT THE BLEEDING SITE. THE PT REFUSED SURGERY. AROUND THE MIDDLE OF MAY THE PT HAD A SUDDEN DEVELOPMENT OF PSEUDOCYST-DUODENAL FISTULA BELIEVED TO HAVE BEEN CAUSED FROM INCREASING PRESSURE IN THE PSEUDOCYST FROM ACTIVE RE-BLEEDING. THE STENT LUMEN WAS FOUND TO BE OCCLUDED WITH CLOT AND CONTAINED BRIGHT RED BLOOD WITHIN THE PSEUDOCYST. THE PT HAD A METAL BILIARY STENT PLACED IN THE PSEUDOCYST AND HE WAS TAKEN TO SURGERY FOR AN ANTERIOR GASTROTOMY ON (B)(6) 2015. THE AXIOS STENT WAS REMOVED AND THE PHYSICIAN CONFIRMED THAT THE STENT HAD ERODED THROUGH THE SPLENIC ARTERY. THE ARTERY WAS OVER SEWN SEVERAL TIMES WITHOUT SUCCESS. AN EMBOLIC COIL WAS THEN PLACED IN THE ARTERY WHICH SUCCEEDED IN STOPPING THE BLEEDING. OTHER FINDINGS WERE THAT THE PSEUDOCYST-DUODENAL FISTULA WAS COMPLETELY CONTAINED. THE PT CAME BACK ON (B)(6) 2015 IN SEPTIC SHOCK AND DIED 3 DAYS LATER ON (B)(6) 2015 AFTER THE FAMILY REQUESTED COMFORT MEASURES ONLY. ACCORDING TO THE PHYSICIAN, THE PT'S PRIMARY CAUSE OF DEATH WAS GRAM NEGATIVE SEPTIC SHOCK WITH A SECONDARY CAUSE OF DEATH DUE TO SPLENIC ARTERY BLEEDING. IN THE PHYSICIAN'S ASSESSMENT, HE FELT THAT THE PT COULD HAVE RECOVERED IF SUPPORTS WERE NOT REMOVED. THE PHYSICIAN ALSO NOTED THAT HE BELIEVED THAT THE STENT PERFORMED AS INDICATED AND FELT IT WAS NOT THE FAULT OF DESIGN ON THE PROCEDURE ITSELF. HE HAS SEEN PIGTAIL STENTS CAUSE EROSION OF THIS TYPE AS WELL, IT IS A KNOWN RISK. HE FELT THAT THE EROSION WAS CAUSED BY THE COLLAPSING OF THE PSEUDOCYST BRINGING THE BACK WALL IN CONTACT WITH THE AXIOS STENT. THIS AREA SEES A LOT OF MOVEMENT FROM THE DIAPHRAGM, INTER-ABDOMINAL ACTIVITY AND GENERAL BODY MOVEMENT. THIS SMALL BUT CONSTANT MOVEMENT CAUSE THE EROSION OF THE SPLENIC ARTERY WALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392621 AXIOS STENT AND DELIVERY SYSTEM PANCREATIC STENT, PCU XLUMENA INC., BOSTON SCIENTIFIC CO AXS-15-10

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death