BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLFLEX BILIARY

    MDR report key: 25272641 · Received May 25, 2026

    Report

    Report Number
    3005099803-2026-02064
    Event Type
    Injury
    Date Received
    May 25, 2026
    Date of Event
    April 1, 2017
    Report Date
    May 25, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    PNB
    PMA / PMN Number
    K240464
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: THE DATE OF THE EVENT IS APPROXIMATED BASED ON THE MONTH AND YEAR THE STUDY WAS CONDUCTED. BLOCK D4, H4: THE ARTICLE DID NOT PROVIDE THE COMPLAINT DEVICE UPN AND LOT NUMBER. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. BLOCK G2: LITERATURE SOURCE: SHOHEI ASADA, ET AL., "EFFICACY OF MULTI-HOLE SELF-EXPANDABLE METALLIC STENTS VERSUS PARTIALLY COVERED SELF-EXPANDABLE METALLIC STENTS IN PATIENTS WITH MALIGNANT DISTAL BILIARY OBSTRUCTION CAUSED BY UNRESECTABLE PANCREATIC CANCER: A RETROSPECTIVECOMPARATIVE COHORT STUDY IN JAPAN." CLINICAL ENDOSCOPY 2025; 58: 744-756. HTTPS://DOI.ORG/10.5946/CE.2024.340 BLOCK H6: IMDRF DEVICE CODE A150101 CAPTURES THE REPORTABLE EVENT OF STENT FAILURE TO EXPAND. IMDRF DEVICE CODE A010402 CAPTURES THE REPORTABLE EVENT OF STENT MIGRATION. IMDRF DEVICE CODE A0106 CAPTURES THE REPORTABLE EVENT OF STENT OBSTRUCTION. IMDRD DEVICE CODE A22 CAPTURES THE REPORTABLE EVENT OF STENT OVERGROWTH. IMDRF PATIENT CODE E1021 CAPTURES THE REPORTABLE PATIENT COMPLICATION OF PANCREATITIS. IMDRF PATIENT CODE E2326 CAPTURES THE REPORTABLE PATIENT COMPLICATION OF CHOLECYSTITIS. IMDRF PATIENT CODE E1109 CAPTURES THE REPORTABLE PATIENT COMPLICATION OF CHOLANGITIS. IMDRF PATIENT CODE E172001 CAPTURES THE REPORTABLE PATIENT COMPLICATION OF LIVER ABSCESS. IMDRF PATIENT CODE E0506 CAPTURES THE REPORTABLE PATIENT COMPLICATION OF HEMORRHAGE. IMDRF IMPACT CODE F2202 CAPTURES THE ADDITIONAL ENDOSCOPIC PROCEDURE. IMDRF IMPACT CODE F2301 CAPTURES THE USED OF ADDITIONAL DEVICE TO COMPLETE THE PROCEDURE. IMDRF IMPACT CODE F0101 CAPTURES THE REPORTABLE EVENT OF RECURRENT BILIARY OBSTRUCTION.

    Description of Event or Problem · 0

    BOSTON SCIENTIFIC BECAME AWARE OF AN EVENT INVOLVING A WALLFLEX BILIARY PARTIALLY COVERED STENT THROUGH THE ARTICLE "EFFICACY OF MULTI-HOLE SELF-EXPANDABLE METALLIC STENTS IN PATIENTS WITH MALIGNANT DISTAL BILIARY OBSTRUCTION CAUSED BY UNRESECTABLE PANCREATIC CANCER: A RETROSPECTIVE COMPARATIVE COHORT STUDY IN JAPAN" BY SHOHEI ASADA, ET AL. THE STUDY AIMED TO COMPARE THE STENT PATENCY BETWEEN THE NOVEL MULTI-HOLE SELF-EXPANDABLE METALLIC STENT AND CONVENTIONALLY PARTIALLY COVERED SEMS FOR MALIGNANT DISTAL BILIARY OBSTRUCTION IN PATIENTS WITH PANCREATIC CARCINOMA. BETWEEN APRIL 2017 AND DECEMBER 2022, 94 PATIENTS UNDERWENT PC-SEMS PLACEMENT. A 10 MM-DIAMETER WALLFLEX BILIARY PARTIALLY COVERED STENT WAS IMPLANTED DURING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP). THE ARTICLE REPORTS THE FOLLOWING DEVICE-RELATED PROBLEMS AND ADVERSE EVENTS AMONG STUDY PARTICIPANTS: STENT EXPANSION FAILURE, LATER CORRECTED USING A 10 MM BALLOON CATHETER, STENT OBSTRUCTION DUE TO SLUDGE OR FOOD IMPACTION, RECURRENT BILIARY OBSTRUCTION, STENT OVERGROWTH, STENT MIGRATION, PANCREATITIS, CHOLECYSTITIS, LIVER ABSCESS, AND HEMORRHAGE. PLEASE SEE THE REFERENCED ARTICLE FOR FULL DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489470 WALLFLEX BILIARY BILIARY STENT SYSTEM FOR BENIGN STRICTURES PNB BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1