BEUDAMED
    FDA Adverse Event Death Summary report: N

    AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM

    MDR report key: 19684827 · Received July 5, 2024

    Report

    Report Number
    3005099803-2024-03219
    Event Type
    Death
    Date Received
    July 5, 2024
    Date of Event
    June 1, 2024
    Report Date
    July 5, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    PCU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: THE EXACT DATE OF THE EVENT IS UNKNOWN. THE PROVIDED EVENT DATE WAS CHOSEN AS A BEST ESTIMATE BASED ON THE DATE THAT THE MANUFACTURER BECAME AWARE OF THE EVENT. BLOCK E1: INITIAL REPORTER FIRST NAME: MARIA CRISTINA CONTI INITIAL REPORTER EMAIL: [email protected] OR [email protected]. BLOCK G2: LITERATURE SOURCE: MARIA CRISTINA CONTI BELLOCCHI ET AL. "ENDOSCOPIC ULTRASOUND-GUIDED GASTROENTEROSTOMY VERSUS ENTERAL STENTING FOR MALIGNANT GASTRIC OUTLET OBSTRUCTION: A RETROSPECTIVE PROPENSITY SCORE-MATCHED STUDY" CANCERS 2024,16, 724. HTTPS://DOLORG/10.3390/CANCERS16040724 BLOCK H6: IMDRF IMPACT CODE F02 CAPTURES THE REPORTABLE EVENT OF DEATH. IMDRF PATIENT CODE E1109 CAPTURES THE REPORTABLE EVENT OF CHOLANGITIS.

    Description of Event or Problem · 0

    BOSTON SCIENTIFIC CORPORATION BECAME AWARE OF THE FOLLOWING EVENT THAT INVOLVES AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM THROUGH THE ARTICLE TITLED, "ENDOSCOPIC ULTRASOUND-GUIDED GASTROENTEROSTOMY VERSUS ENTERAL STENTING FOR MALIGNANT GASTRIC OUTLET OBSTRUCTION: A RETROSPECTIVE PROPENSITY SCORE-MATCHED STUDY", BY M.C. CONTI BELLOCCHI, ET AL. THE STUDY AIMS TO COMPARE TWO ENDOSCOPIC PROCEDURES FOR MANAGING MALIGNANT GASTRIC OUTLET OBSTRUCTION. THIS IS A RETROSPECTIVE OBSERVATIONAL STUDY INVOLVING TWO REFERRAL (MORE THAN 100 INTERVENTIONAL ENDOSCOPIC ULTRASOUND PROCEDURES/YEAR) ITALIAN CENTERS (THE ENDOSCOPY UNIT OF UNIVERSITY HOSPITAL OF VERONA AND THE ENDOSCOPY UNIT OF FONDAZIONE POLICLINICO UNIVERSITARIO CAMPUS BIO-MEDICO OF ROME). ALL CONSECUTIVE ADULT PATIENTS REFERRED FOR ENDOSCOPIC TREATMENT (ENDOSCOPIC ULTRASOUND-GUIDED GASTROENTEROSTOMY (EUS-GE) OR ENTERAL STENTING (ES)) OF MALIGNANT GASTRIC OUTLET OBSTRUCTION BETWEEN JUNE 2017 AND JUNE 2023 WERE RETROSPECTIVELY EVALUATED. EUS-GE PROCEDURES WERE PERFORMED BY ENDOSONOGRAPHERS WITH MORE THAN 5 YEARS OF EXPERIENCE IN INTERVENTIONAL EUS-GUIDED PROCEDURES. EUS-GE WERE PERFORMED IN A SUITE EQUIPPED WITH FLUOROSCOPY WITH PATIENTS UNDER GENERAL ANESTHESIA AND OROTRACHEAL INTUBATION, IN A SUPINE POSITION, USING CARBON DIOXIDE INSUFFLATION. ELECTROCAUTERY-ENHANCED LUMEN APPOSING METAL STENTS (LAMS) OF 20 MM LUMEN DIAMETER (HOT-AXIOS) WERE USED TO CREATE THE ANASTOMOSIS UNDER BOTH FLUOROSCOPY AND EUS GUIDANCE. IN ALL CASES, THE ANTEGRADE DIRECT FREE-HAND TECHNIQUE WAS USED FOR EUS-GE. ES PROCEDURES WERE PERFORMED BY EXPERT ENDOSCOPISTS WITH PATIENTS UNDER CONSCIOUS OR DEEP SEDATION IN A SUPINE POSITION. AFTER PASSING A 0.035-INCH GUIDEWIRE THROUGH THE STENOSIS AND ESTIMATING THE STENOSIS LENGTH THROUGH THE INJECTION OF CONTRAST MEDIUM, A NITINOL UNCOVERED SELF-EXPANDING METAL STENT (ENTERAL WALLFLEX) WAS CAREFULLY ADVANCED OVER THE WIRE UNDER FLUOROSCOPY AND DEPLOYED ACROSS THE STENOSIS. ALL SELF-EXPANDING METAL STENTS (SEMS) WERE 22 MM WIDE, WHILE SEMS LENGTH (6, 9, OR 12 CM) WAS CHOSEN ACCORDING TO THE EXTENT AND MORPHOLOGY OF THE STENOSIS. AT THE END OF THE PROCEDURE, THE POSITION AND THE EFFICACY OF THE SEMS WERE SYSTEMATICALLY CHECKED BY CONTRAST INJECTION UNDER FLUOROSCOPY. TECHNICAL SUCCESS WAS DEFINED AS THE CORRECT PLACEMENT OF LAMS FOR EUS-GE (EVIDENCE OF BLUE STAINED FLUID FLOWING INTO THE STOMACH) OR SEMS FOR ES (COVERING THE FULL LENGTH OF THE STENOSIS). ACCORDING TO THE STUDY, IN TWO PATIENTS, CHOLANGITIS OCCURRED AFTER PERCUTANEOUS BILIARY DRAINAGE WHICH RESULTED TO DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466744 AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM PANCREATIC STENT, COVERED, METALLIC, REMOVABLE PCU BOSTON SCIENTIFIC CORPORATION M00553560

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention