BEUDAMED
    FDA Adverse Event Death Summary report: N

    AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM

    MDR report key: 19146920 · Received April 19, 2024

    Report

    Report Number
    3005099803-2024-01826
    Event Type
    Death
    Date Received
    April 19, 2024
    Date of Event
    March 31, 2023
    Report Date
    April 25, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    PCU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: THE EXACT DATE OF EVENT WAS NOT REPORTED. THE ARTICLE PUBLISHED DATE IS USED FOR THE ESTIMATED DATE OF EVENT. BLOCK D4, H4: THE LITERATURE ARTICLE DID NOT PROVIDE THE SUSPECT DEVICE UPN AND LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. BLOCK G2: LITERATURE SOURCE: A. CANAKIS, ET AL. "BENEFITS OF EUS-GUIDED GASTROENTEROSTOMY OVER SURGICAL GASTROJEJUNOSTOMY IN THE PALLIATION OF MALIGNANT GASTRIC OUTLET OBSTRUCTION: A LARGE MULTICENTER EXPERIENCE" GASTROINTESTINAL ENDOSCOPY VOLUME 98, NO. 3:2023; DOI: HTTPS://DOI.ORG/10.1016/J.GIE.2023.03.022. BLOCK H6: IMDRF IMPACT CODE F02 CAPTURES THE REPORTABLE EVENT OF PATIENT DEATH.

    Additional Manufacturer Narrative · 0

    BLOCK B3: THE EXACT DATE OF EVENT WAS NOT REPORTED. THE ARTICLE PUBLISHED DATE IS USED FOR THE ESTIMATED DATE OF EVENT. BLOCK D4, H4: THE LITERATURE ARTICLE DID NOT PROVIDE THE SUSPECT DEVICE UPN AND LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. BLOCK G2: LITERATURE SOURCE: A. CANAKIS, ET AL. "BENEFITS OF EUS-GUIDED GASTROENTEROSTOMY OVER SURGICAL GASTROJEJUNOSTOMY IN THE PALLIATION OF MALIGNANT GASTRIC OUTLET OBSTRUCTION: A LARGE MULTICENTER EXPERIENCE" GASTROINTESTINAL ENDOSCOPY VOLUME 98, NO. 3:2023; DOI: HTTPS://DOI.ORG/10.1016/J.GIE.2023.03.022. BLOCK H6: IMDRF IMPACT CODE F02 CAPTURES THE REPORTABLE EVENT OF PATIENT DEATH. BLOCK H11: BLOCK B5 HAS BEEN CORRECTED.

    Description of Event or Problem · 0

    BOSTON SCIENTIFIC BECAME AWARE OF THE EVENT INVOLVING AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM THROUGH A LITERATURE ARTICLE TITLED, "BENEFITS OF EUS-GUIDED GASTROENTEROSTOMY OVER SURGICAL GASTROJEJUNOSTOMY IN THE PALLIATION OF MALIGNANT GASTRIC OUTLET OBSTRUCTION: A LARGE MULTICENTER EXPERIENCE" BY DR. (B)(6). THIS MULTICENTER, RETROSPECTIVE COMPARATIVE STUDY INCLUDED ADULT PATIENTS UNDERGOING PALLIATIVE SURGICAL GASTROJEJUNOSTOMY (SGJ) OR ENDOSCOPIC ULTRASOUND GUIDED GASTROENTEROSTOMY (EUS-GE) FOR MALIGNANT GASTRIC OUTLET OBSTRUCTION (MGOO) AT 6 CENTERS. EUS-GE PROCEDURES PERFORMED FROM (B)(6) 2017 TO (B)(6) 2022 AND SGJ FROM (B)(6) 2005 TO (B)(6) 2020 WERE INCLUDED. A TOTAL OF 310 PATIENTS WERE INCLUDED (EUS-GE, N = 187; SGJ, N = 123). THE 2 GROUPS PREDOMINANTLY HAD OBSTRUCTION AT THE SECOND PORTION OF THE DUODENUM FOLLOWED BY THE DUODENAL BULB AS THE SITE OF OBSTRUCTION. THE TYPE OF MALIGNANCY DID DIFFER BETWEEN THE 2 GROUPS, WITH EUS-GE GROUPS HAVING LOWER RATES OF PANCREATIC, GALLBLADDER, BILIARY, AND EXTRALUMINAL CANCERS BUT HIGHER RATES OF GASTRIC, DUODENAL, AND METASTATIC CANCER. THE RESULTS SHOW THAT WHEN CONSIDERING THE TIME VARIABILITY OF THE OUTCOME (RIGHT-CENSORING EVENT), THE ENDOSCOPIC ULTRASOUND GUIDED GASTROENTEROSTOMY HAD HIGHER RISK OF DEATH COMPARED TO SURGICAL GASTROJEJUNOSTOMY.

    Description of Event or Problem · 0

    BOSTON SCIENTIFIC BECAME AWARE OF THE EVENT INVOLVING AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM THROUGH A LITERATURE ARTICLE TITLED, "BENEFITS OF EUS-GUIDED GASTROENTEROSTOMY OVER SURGICAL GASTROJEJUNOSTOMY IN THE PALLIATION OF MALIGNANT GASTRIC OUTLET OBSTRUCTION: A LARGE MULTICENTER EXPERIENCE" BY DR. ANDREW CANAKIS, ET AL. THIS MULTICENTER, RETROSPECTIVE COMPARATIVE STUDY INCLUDED ADULT PATIENTS UNDERGOING PALLIATIVE SURGICAL GASTROJEJUNOSTOMY (SGJ) OR ENDOSCOPIC ULTRASOUND GUIDED GASTROENTEROSTOMY (EUS-GE) FOR MALIGNANT GASTRIC OUTLET OBSTRUCTION (MGOO) AT 6 CENTERS. EUS-GE PROCEDURES PERFORMED FROM (B)(6) 2022 AND SGJ FROM (B)(6) 2005 TO (B)(6)2020 WERE INCLUDED. A TOTAL OF (B)(4) PATIENTS WERE INCLUDED (EUS-GE, N = 187; SGJ, N = 123). THE 2 GROUPS PREDOMINANTLY HAD OBSTRUCTION AT THE SECOND PORTION OF THE DUODENUM FOLLOWED BY THE DUODENAL BULB AS THE SITE OF OBSTRUCTION. THE TYPE OF MALIGNANCY DID DIFFER BETWEEN THE 2 GROUPS, WITH EUS-GE GROUPS HAVING LOWER RATES OF PANCREATIC, GALLBLADDER, BILIARY, AND EXTRALUMINAL CANCERS BUT HIGHER RATES OF GASTRIC, DUODENAL, AND METASTATIC CANCER. THE RESULTS SHOW THAT WHEN CONSIDERING THE TIME VARIABILITY OF THE OUTCOME (RIGHT-CENSORING EVENT), THE ENDOSCOPIC ULTRASOUND GUIDED GASTROENTEROSTOMY HAD HIGHER RISK OF DEATH COMPARED TO SURGICAL GASTROJEJUNOSTOMY. NOTE: IT WAS REPORTED THAT THE AXIOS STENT WAS INTENDED TO BE PLACED TO TREAT A MALIGNANT GASTRIC OUTLET OBSTRUCTION (GOO). HOWEVER, PER THE AXIOS STENT AND ELECTROCAUTERY- ENHANCED DELIVERY SYSTEM DIRECTIONS FOR USE, THE STENT IS INDICATED FOR USE TO FACILITATE TRANSGASTRIC OR TRANSDUODENAL ENDOSCOPIC DRAINAGE OF PANCREATIC PSEUDOCYST OR A WALLED-OFF NECROSIS WITH >= 70% FLUID CONTENT, GALLBLADDER IN PATIENTS WITH ACUTE CHOLECYSTITIS WHO ARE AT HIGH RISK OR UNSUITABLE FOR SURGERY AND BILE DUCT AFTER FAILED ERCP IN PATIENTS WITH BILIARY OBSTRUCTION DUE TO A MALIGNANT STRICTURE. THE DEVICE IS NOT INDICATED FOR PLACEMENT FOR GASTRIC OUTLET OBSTRUCTION (GOO).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1842346 AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM PANCREATIC STENT, COVERED, METALLIC, REMOVABLE PCU BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death