BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM

    MDR report key: 18697526 · Received February 13, 2024

    Report

    Report Number
    3005099803-2024-00331
    Event Type
    Injury
    Date Received
    February 13, 2024
    Date of Event
    August 20, 2020
    Report Date
    February 13, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    PCU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H3: 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: KRAFFT, M., ET AL. "SHORTENED-INTERVAL DUAL-SESSION EDGE REDUCES THE RISK OF LAMS DISLODGEMENT WHILE FACILITATING TIMELY ERCP" DIG DIS SCI. 2021 AUGUST; 66(8): 2776-2785. DOI:10.1007/S10620-020-06551-5. BLOCK H6: IMDRF DEVICE CODE A1502 CAPTURES THE REPORTABLE EVENT OF STENT POSITIONING ISSUE. IMDRF DEVICE CODE A010402 CAPTURES THE REPORTABLE EVENT OF STENT MIGRATION. IMDRF PATIENT CODE E1002 CAPTURES PATIENT COMPLICATION OF ABDOMINAL PAIN. IMDRF PATIENT CODE E2114 CAPTURES PATIENT COMPLICATION OF PERFORATION. IMDRF IMPACT CODE F08 CAPTURES THE REPORTABLE EVENT OF PROLONGED HOSPITALIZATION. IMDRF IMPACT CODE F2301 CAPTURES THE ADDITIONAL STENT IMPLANTED TO COMPLETE THE PROCEDURE. IMDRF IMPACT CODE F2202 CAPTURES THE ADDITIONAL ENDOSCOPIC PROCEDURE. IMDRF IMPACT CODE F2303 CAPTURES POST-PROCEDURAL ANTIMICROBIAL THERAPY FOR COMPLETE LAMS DISLODGEMENT.

    Description of Event or Problem · 0

    BOSTON SCIENTIFIC CORPORATION BECAME AWARE OF THE FOLLOWING EVENT THAT INVOLVES A 20 MM AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM THROUGH THE ARTICLE "SHORTENED-INTERVAL DUAL-SESSION EDGE REDUCES THE RISK OF LAMS DISLODGEMENT WHILE FACILITATING TIMELY ERCP" BY KRAFFT, M., ET. THE STUDY AIMS TO FIND AN ALTERNATE TIME INTERVAL THAT BALANCES THE DILEMMAS FACING BOTH SINGLE-SESSION AND DUAL-SESSION EDGE. A SINGLE-CENTER RETROSPECTIVE STUDY OF 21 PATIENTS WITH ROUX-EN-Y GASTRIC BYPASS (RYGB) ANATOMY WHO UNDERWENT ENDOSCOPIC ULTRASOUND DIRECTED TRANSGASTRIC ERCP (EDGE), VIA 20-MM ELECTROCAUTERY-ENHANCED LUMEN-APPOSING METAL STENT WAS CONDUCTED BETWEEN MARCH 2018 AND FEBRUARY 2020. PATIENTS IN THE STUDY UNDERWENT ONE OF TWO FORMS OF EDGE, DISTINGUISHED BY DIFFERING TIME INTERVALS BETWEEN STEPS 1 AND 2. "SINGLE-SESSION" EDGE REFERRED TO COMPLETION OF STEPS 1 AND 2 IN TANDEM, WITHIN THE SAME (INDEX) ENDOSCOPIC SESSION. "SHORTENED-INTERVAL DUAL-SESSION" EDGE REFERRED TO ENDOSCOPIC ULTRASOUND DIRECTED GASTRO-GASTROSTOMY EUS-GG (STEP 1) PERFORMED DURING THE INDEX ENDOSCOPY, FOLLOWED BY TRANSGASTRIC ERCP (STEP 2), COMPLETED 2-4 DAYS AFTER STEP 1. THE GASTROGASTRIC FISTULA (GGF)/ JEJUNOGASTRIC FISTULA (JGF) WAS IMMATURE IN BOTH STUDY ARMS. PER THE LITERATURE, A TOTAL OF 11 PATIENTS (SIX FEMALES; MEAN AGE 54.9 YEARS) UNDERWENT SINGLE-SESSION EDGE VIA GGF (N = 7, 64%) OR JGF (N = 4, 36%), DURING THE STUDY PERIOD. INDICATIONS FOR SINGLE-SESSION EDGE WERE CHOLEDOCHOLITHIAIS (N = 6, 55%), MALIGNANT BILIARY STRICTURE (N = 3, 27%), CHOLANGITIS (N = 1, 9%), AND POSTOPERATIVE BILE LEAK (N = 1, 9%). TECHNICAL SUCCESS OF SINGLE-SESSION EDGE WAS 91% (N = 10). LAMS DISLODGEMENT OCCURRED IN 5/11 CASES (45%) OF SINGLE-SESSION EDGE. IN THE THREE CASES OF INCOMPLETE LAMS DISLODGEMENT (3/5; 60%), PHYSICIANS WERE UNABLE TO SUCCESSFULLY REPOSITION THE LAMS USING GRASPING FORCEPS, A BRIDGING ESOPHAGEAL FULLY COVERED SELF-EXPANDING METAL STENT (FCSEMS) WAS DEPLOYED OVER THE GUIDEWIRE (OTW) THROUGH THE INDWELLING LAMS. COMPLETE LAMS DISLODGEMENT (ACUTE PERFORATION) OCCURRED IN 2/5 (40%) CASES (JGF N = 1, GGF N = 1). IN BOTH CASES, THE COMPLETELY DISPLACED LAMS WAS EXTRACTED PRIOR TO DEPLOYMENT OF A BRIDGING ESOPHAGEAL FCSEMS. ADVERSE EVENTS OF MILD SEVERITY (POST-PROCEDURAL ABDOMINAL PAIN NECESSITATING PROLONGATION OF HOSPITALIZATION) OCCURRED IN 2/11 (18%) OF SINGLE-SESSION EDGE CASES; BOTH ADVERSE EVENTS OCCURRED IN PATIENTS WITH COMPLETE LAMS DISLODGEMENT. THE FIRST ADVERSE EVENT OF MILD SEVERITY OCCURRED IN THE PATIENT WHO EXPERIENCED COMPLETE LAMS DISLODGEMENT, REQUIRING NOTES TO FACILITATE DEPLOYMENT OF A BRIDGING ESOPHAGEAL FULLY COVERED SELF-EXPANDING METAL STENT (FCSEMS). THE SECOND ADVERSE EVENT OF MILD SEVERITY OCCURRED IN CONJUNCTION WITH TECHNICAL FAILURE OF EDGE. DURING THE WITHDRAWAL OF THE DUODENOSCOPE, INCOMPLETE LAMS DISLODGEMENT WAS DETECTED AND SALVAGED USING A BRIDGING ESOPHAGEAL FCSEMS, PLACED OTW AND THROUGH THE INDWELLING LAMS. REPEAT TRANSGASTRIC ERCP WAS SUCCESSFUL 2 DAYS LATER IN THIS PATIENT. A TOTAL OF TEN PATIENTS (EIGHT FEMALES; MEAN AGE 60.5 YEARS) UNDERWENT SHORTENED-INTERVAL DUAL-SESSION EDGE VIA GGF (N = 6, 60%) OR JGF (N = 4, 40%), DURING THE STUDY PERIOD. THE MEDIAN INTERVAL BETWEEN EUS-GG AND TRANSGASTRIC ERCP WAS 2 DAYS (RANGE 2-4). INDICATIONS FOR SHORTENED-INTERVAL DUAL-SESSION EDGE WERE CHOLEDOCHOLITHIAIS (N = 6, 60%), MALIGNANT BILIARY STRICTURE (N = 1, 10%), CHOLANGITIS (N = 1, 10%), POSTOPERATIVE BILE LEAK (N = 1, 10%), AND ACUTE-ON-CHRONIC PANCREATITIS (N = 1, 10%). TECHNICAL SUCCESS WAS 100% (N = 10/10). INCOMPLETE LAMS DISLODGEMENT (GGF) OCCURRED IN ONE CASE (10%) AND WAS SUCCESSFULLY MANAGED USING A BRIDGING ESOPHAGEAL FCSEMS DEPLOYED OTW AND THROUGH THE INDWELLING LAMS. TECHNICAL SUCCESS WAS 100%, INCLUDING THE PATIENT WITH INCOMPLETE LAMS DISLODGEMENT. NO ADVERSE EVENTS OCCURRED IN THIS GROUP. DELAYED STENT MIGRATION DID NOT OCCUR IN THIS COHORT. POST-PROCEDURAL ANTIMICROBIAL THERAPY OF 5-DAY DURATION WAS ADMINISTERED TO PATIENTS WHO EXPERIENCED COMPLETE LAMS DISLODGEMENT (I.E., TRANSIENT PERFORATION) DURING THE PROCEDURE. THE DECISION TO ADMINISTER A 5-DAY COURSE OF PROPHYLACTIC ANTIBIOTICS FOLLOWING AN EPISODE OF LAMS DISLODGEMENT WAS EXTRAPOLATED FROM ASGE RECOMMENDATIONS TO ADMINISTER ANTIBIOTICS FOR 3-5 DAYS AFTER EUS-FNA OF CYSTIC LESIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2157717 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 Hospitalization| R