BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM

    MDR report key: 16611627 · Received March 24, 2023

    Report

    Report Number
    3005099803-2023-01580
    Event Type
    Injury
    Date Received
    March 24, 2023
    Date of Event
    January 1, 2019
    Report Date
    March 24, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    PCU
    PMA / PMN Number
    K220112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ONE OF THE THIRTEEN PATIENTS WITH STENT POSITIONING ISSUE IS A 58-YEAR-OLD, FEMALE. APPROXIMATED BASED ON THE YEAR THE DATA ON ALL PATIENTS WITH SYMPTOMATIC SIMPLE HEPATIC CYSTS (SHCS) OF THE RIGHT OR LEFT LIVER LOBE WERE RETROSPECTIVELY ANALYZED. THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. LITERATURE SOURCE: D'ERRICO F., DERHY S., FAZI M., MEMEO, R., DECEMBRINO, F., DE PALMA, G., AND DONATELLI G. (2022). EUS-GUIDED ENDOSCOPIC INTERNAL DRAINAGE WITH LUMEN-APPOSING METAL STENT FOR SYMPTOMATIC HEPATIC CYSTS: A CASE SERIES (WITH VIDEO). ENDOSCOPY INTERNATIONAL OPEN 2023; 11(01): 76 - 80. DOI:10.1055/A-1968-7596. IMDRF DEVICE CODE A1502 CAPTURES THE REPORTABLE EVENT OF STENT POSITIONING ISSUE. IMDRF PATIENT CODE E0301 CAPTURES THE REPORTABLE PATIENT COMPLICATION OF ANEMIA. IMPACT CODE F2301 IS BEING USED TO CAPTURE THE ADDITIONAL DEVICE REQUIRED TO REMOVE THE STENT AND THE USED OF AN OVESCO CLIP TO CLOSE THE PUNCTURE SITE. IMPACT CODE F23 IS BEING USED TO CAPTURE THE ADDITIONAL INTERVENTION OF IMMEDIATE DRAINAGE UNDER RADIOLOGIC GUIDANCE AFTER STENT REMOVAL. IMPACT CODE F2302 IS BEING USED TO CAPTURE BLOOD TRANSFUSION.

    Description of Event or Problem · 0

    BOSTON SCIENTIFIC BECAME AWARE OF AN EVENT INVOLVING AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM THROUGH THE ARTICLE, "EUS-GUIDED ENDOSCOPIC INTERNAL DRAINAGE WITH LUMEN-APPOSING METAL STENT FOR SYMPTOMATIC HEPATIC CYSTS: A CASE SERIES (WITH VIDEO)" BY GIANFRANCO DONATELLI, ET AL. ACCORDING TO THE LITERATURE, THE AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS USED TO TREAT A SIMPLE HEPATIC CYST (SHC) OF THE RIGHT AND LEFT LIVER. ON AVERAGE, THE SIZE OF THE CYSTS TREATED WAS 22.2CM AND THE BIGGEST WAS 40CM (11-40CM). THEY WERE UNILOCULAR WITH MOSTLY LIQUID CONTENT WITH ABOUT 30% OF THE TOTAL VOLUME CORPUSCULAR AND THICK. A PREOPERATIVE CT SCAN WAS PERFORMED IN ALL PATIENTS AS WELL AS A POSTOPERATIVE ONE AT 1 WEEK AND 3 WEEKS AFTER LAMS PLACEMENT. THIRTEEN PATIENTS (9 MALE, 4 FEMALE) WITH AN AVERAGE AGE OF 71.9 YEARS (45-98) UNDERWENT ENDOSCOPIC ULTRASOUND (EUS)-GUIDED LAMS CYST DRAINAGE BECAUSE OF SIGNIFICANT SYMPTOMS. THE TECHNIQUE USED WAS THE FREE-HAND ONE. A TRANSESOPHAGEAL APPROACH WAS USED IN FIVE CASES, TRANSGASTRIC IN FIVE, AND TRANSDUODENAL IN THREE OF THEM. FLUOROSCOPY WAS NOT USED IN ALL CASES. IN ALL PATIENTS, ASPIRATION OF LIQUID WAS PERFORMED FOR CULTURAL AND BIOCHEMICAL EXAMINATIONS. ACCORDING TO THE STUDY, ONLY 12 OF 13 (92.3%) AXIOS REMAINED IN PLACE. IN ONE PATIENT WHO UNDERWENT TRANSESOPHAGEAL DRAINAGE FOR A HUGE LEFT LIVER CYST, AFTER DEPLOYMENT OF THE AXIOS STENT AND ASPIRATION OF THE LIQUID FOR BACTERIOLOGY, THE PROXIMAL FLANGE SLIPPED INTO THE PERITONEAL CAVITY BETWEEN THE CARDIA AND THE LEFT LIVER CYST. THE ACCESS CAUTERY DEFECT WAS PROMPTLY CATHETERIZED (NATURAL ORIFICE TRANSLUMINAL ENDOSCOPIC SURGERY), WHICH WOULD ALLOW FOR THE LAMS ANCHORED IN THE HEPATIC PARENCHYMA (CYST) TO BE FOUND, GRASPED, AND PULLED WITH THE AIM OF REPOSITIONING IT. HOWEVER, THIS WAS TECHNICALLY DIFFICULT, SO THE DECISION WAS MADE TO REMOVE THE LAMS AND CLOSE THE ESOPHAGEAL DEFECT WITH AN OVESCO CLIP. IMMEDIATE DRAINAGE UNDER RADIOLOGIC GUIDANCE WAS PERFORMED. WHEN THE SHC RECURRED 7 MONTHS LATER, EUS-GUIDED LAMS DRAINAGE AGAIN WAS PERFORMED, AND IT WAS SUCCESSFUL. ONE (1) OUT OF TWELVE (12) PATIENTS PRESENTED MELENA WITH ANEMIA WITHOUT ACTIVE BLEEDING ON CT SCAN, 3 WEEKS AFTER INDEX EUS. PATIENT REQUIRED BLOOD TRANSFUSION. LAMS WAS EXCHANGED FOR A PIGTAIL STENT AS SCHEDULED, AT 4 WEEKS. DRAINAGE WAS SUCCESSFUL IN THE OTHER 12 PATIENTS (100% ) WITH DISCHARGE FROM THE HOSPITAL WITHIN THE NEXT FEW DAYS ON A NORMAL DIET. ALL PATIENTS UNDERWENT A CT SCAN 7 TO 21 DAYS AFTER THE DRAINAGE AND THEY WERE SCHEDULED FOR LAMS REMOVAL AT 4 WEEKS. IN ALL 12 PATIENTS, SYMPTOMS IMPROVED, AND SEPSIS RESOLVED; HOWEVER, ONLY SEVEN PATIENTS (58.3% ) UNDERWENT ENDOSCOPIC RE-LOOK IN ORDER TO REMOVE LAMS AND REPLACE IT WITH A DOUBLE PIGTAIL STENT FOR 3 MONTHS. FOR THE OTHER FIVE PATIENTS, CONSIDERING THEIR AGE, COMORBIDITIES, AND SUCCESSFUL RECOVERY POST PROCEDURE, LAMS WAS LEFT IN PLACE UNTIL DEATH, WITH AN AVERAGE FOLLOW-UP OF 9 MONTHS WITHOUT ADVERSE EVENTS (AES) OR INFLAMMATORY SYNDROME. AT AN AVERAGE OF 10.5 MONTHS (2- 20) FROM EUS-GUIDED LAMS DRAINAGE, NONE OF THE PATIENTS HAD A RECURRENCE, INCLUDING THOSE WITH LAMS LEFT IN PLACE (6.6; 2-13). NONE OF THE PATIENTS NEEDED A NECROSECTOMY OR DEBRIDEMENT; HOWEVER, IT WAS ALWAYS POSSIBLE TO ENTER THE CYSTIC CAVITY THROUGH THE LAMS AT THE 1-MONTH CONTROL. NOTE: IT WAS REPORTED THAT THE AXIOS STENT AND ELECTROCAUTERY- ENHANCED DELIVERY SYSTEM WAS USED TO TREAT A SIMPLE HEPATIC CYST (SHC) OF THE RIGHT AND LEFT LIVER. ADDITIONALLY, A TRANSESOPHAGEAL APPROACH WAS USED IN FIVE CASES. PER THE AXIOS STENT AND ELECTROCAUTERY-ENHANCED DELIVERY SYSTEM INSTRUCTIONS FOR USE (IFU), THE STENT IS INDICATED FOR USE TO FACILITATE TRANSGASTRIC OR TRANSDUODENAL ENDOSCOPIC DRAINAGE OF A PANCREATIC PSEUDOCYST OR A WALLED-OFF NECROSIS WITH >= 70% FLUID CONTENT, THE GALLBLADDER IN PATIENTS WITH ACUTE CHOLECYSTITIS WHO ARE AT HIGH RISK OR UNSUITABLE FOR SURGERY, AND THE BILE DUCT AFTER A FAILED ERCP IN PATIENTS WITH BILIARY OBSTRUCTION DUE TO A MALIGNANT STRICTURE. THE STENT IS NOT INDICATED FOR SIMPLE HEPATIC CYSTS (SHC) OF THE RIGHT OR LEFT LIVER NEITHER TO USE A TRANSESOPHAGEAL APPROACH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379561 AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM PANCREATIC STENT, COVERED, METALLIC, REMOVABLE PCU BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention