BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM

    MDR report key: 19160265 · Received April 22, 2024

    Report

    Report Number
    3005099803-2024-01855
    Event Type
    Injury
    Date Received
    April 22, 2024
    Date of Event
    March 31, 2024
    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 DEVICE CODE A0106 CAPTURES THE REPORTABLE EVENT OF STENT OBSTRUCTION WITHIN DEVICE (STENT ADVERSE EVENTS). IMDRF PATIENT CODE E1024 CAPTURES THE REPORTABLE PATIENT COMPLICATION OF PERITONITIS. IMDRF PATIENT CODE E2015 CAPTURES THE REPORTABLE PATIENT COMPLICATION OF PNEUMOPERITONEUM. IMDRF PATIENT CODE E0306 CAPTURES THE REPORTABLE PATIENT COMPLICATION OF SEPSIS. IMDRF IMPACT CODE F2202 CAPTURES THE ENDOSCOPIC REINTERVENTION. BLOCK H11: BLOCK B5 HAS BEEN CORRECTED.

    Additional Manufacturer Narrative · 0

    THE EXACT DATE OF EVENT WAS NOT REPORTED. THE ARTICLE PUBLISHED DATE IS USED FOR THE ESTIMATED DATE OF EVENT. THE LITERATURE ARTICLE DID NOT PROVIDE THE SUSPECT DEVICE UPN AND LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. 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. IMDRF DEVICE CODE A0106 CAPTURES THE REPORTABLE EVENT OF STENT OBSTRUCTION WITHIN DEVICE (STENT ADVERSE EVENTS) IMDRF PATIENT CODE E1024 CAPTURES THE REPORTABLE PATIENT COMPLICATION OF PERITONITIS. IMDRF PATIENT CODE E2015 CAPTURES THE REPORTABLE PATIENT COMPLICATION OF PNEUMOPERITONEUM. IMDRF PATIENT CODE E0306 CAPTURES THE REPORTABLE PATIENT COMPLICATION OF SEPSIS. IMDRF IMPACT CODE F2202 CAPTURES THE ENDOSCOPIC REINTERVENTION.

    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 OCTOBER 2017 TO JUNE 2022 AND SGJ FROM MARCH 2005 TO JULY 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. IN TERMS OF SECONDARY OUTCOMES, THE RATES OF OVERALL ADVERSE EVENTS WERE LOWER IN THE EUS-GE GROUP. WHEN EVALUATING THE SPECIFIC ADVERSE EVENTS, EUS GE HAD HIGHER RATES OF STENT ADVERSE EVENTS BUT LOWER RATES OF FEVER OF UNKNOWN ORIGIN, POSTPROCEDURAL NAUSEA/VOMITING, SEPSIS. AND WOUND INFECTION. ADVERSE EVENTS OF BLEEDING, PERITONITIS AND PNEUMOPERITONEUM WERE ALSO NOTED FOR EUS-GE GROUP. HOWEVER, EUS-GE PATIENTS HAD HIGHER RATES OF POSTPROCEDURAL ENDOSCOPIC INTERVENTION. 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).

    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 OCTOBER 2017 TO JUNE 2022 AND SGJ FROM MARCH 2005 TO JULY 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. IN TERMS OF SECONDARY OUTCOMES, THE RATES OF OVERALL ADVERSE EVENTS WERE LOWER IN THE EUS-GE GROUP. WHEN EVALUATING THE SPECIFIC ADVERSE EVENTS, EUS GE HAD HIGHER RATES OF STENT ADVERSE EVENTS BUT LOWER RATES OF FEVER OF UNKNOWN ORIGIN, POSTPROCEDURAL NAUSEA/VOMITING, SEPSIS. AND WOUND INFECTION. ADVERSE EVENTS OF BLEEDING, PERITONITIS AND PNEUMOPERITONEUM WERE ALSO NOTED FOR EUS-GE GROUP. HOWEVER, EUS-GE PATIENTS HAD HIGHER RATES OF POSTPROCEDURAL ENDOSCOPIC INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    943560 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 Required Intervention