BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM

    MDR report key: 16911985 · Received May 11, 2023

    Report

    Report Number
    3005099803-2023-02470
    Event Type
    Injury
    Date Received
    May 11, 2023
    Date of Event
    April 1, 2023
    Report Date
    May 11, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    PCU
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. BLOCK D4, H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER. THEREFORE, THE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. BLOCK G2: RIZZO G.E.M., ET AL. COMPLETE INTRA-PERITONEAL MALDEPLOYMENT OF A LAMS DURING EUS-GEA FOR MGOO: RESCUE RETRIEVAL WITH PERITONEOSCOPY THROUGH NOTES. DIGESTIVE AND LIVER DISEASE 2023: 55(SUPPLEMENT 2) P.S194. BLOCK H6: IMDRF DEVICE CODE A1502 CAPTURES THE REPORTABLE EVENT OF STENT POSITIONING ISSUE. IMDRF IMPACT CODE F19 CAPTURES THE REPORTABLE EVENT OF SURGERY PERFORMED FOR THE REMOVAL OF THE MISDEPLOYED STENT.

    Description of Event or Problem · 0

    BOSTON SCIENTIFIC CORPORATION BECAME AWARE OF THE FOLLOWING EVENT FROM REFERENCED LITERATURE ARTICLE "COMPLETE INTRA-PERITONEAL MALDEPLOYMENT OF A LAMS DURING EUS-GEA FOR MGOO: RESCUE RETRIEVAL WITH PERITONEOSCOPY THROUGH NOTES." ACCORDING TO THE LITERATURE, AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS IMPLANTED TO TREAT A GASTRIC OUTLET OBSTRUCTION (GOO) CONSEQUENT TO A DUODENAL MALIGNANCY DURING AN ENDOSCOPIC ULTRASOUND-GUIDED GASTRO-ENTERIC ANASTOMOSIS (EUS-GEA) PROCEDURE PERFORMED ON AN UNKNOWN DATE. IT WAS REPORTED THAT THE STENT FULLY DEPLOYED IN AN INCORRECT LOCATION. ANOTHER STENT WAS IMPLANTED, AND THE PATIENT WAS SENT TO SURGERY (NATURAL ORIFICE TRANSLUMINAL ENDOSCOPIC SURGERY) FOR THE REMOVAL OF THE MISDEPLOYED STENT. THE STENT WAS REMOVED USING A FOREIGN BODY FORCEPS AND THE IATROGENIC GASTRIC LEAK WAS CLOSED WITH THREE METALLIC CLIPS. NOTE: IT WAS REPORTED THAT THE AXIOS STENT WAS INTENDED TO BE PLACED TO TREAT A GASTRIC OUTLET OBSTRUCTION (GOO) CONSEQUENT TO A DUODENAL MALIGNANCY. 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
    2184140 AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM PANCREATIC STENT, COVERED, METALLIC, REMOVABLE PCU BOSTON SCIENTIFIC CORPORATION M00553560

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Required Intervention