BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLSTENT BILIARY

    MDR report key: 19556876 · Received June 18, 2024

    Report

    Report Number
    3005099803-2024-02901
    Event Type
    Injury
    Date Received
    June 18, 2024
    Date of Event
    April 4, 2023
    Report Date
    June 17, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MUM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EXACT DATE OF EVENT WAS NOT REPORTED. THE ARTICLE PUBLISHED DATE IS USED FOR THE ESTIMATED DATE OF EVENT. THE LITERATURE ARTICLE DID NOT PROVIDE THE SUSPECT DEVICE UPN AND LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. INITIAL REPORTER'S HEALTH CARE FACILITY NAME: (B)(6). INITIAL REPORTER'S NAME AND EMAIL ADDRESS: DR. (B)(6). BLOCK G2: LITERATURE SOURCE: YE SHENG ET AL. "SAFETY AND EFFICACY OF SELF-EXPANDABLE METALLIC STENT COMBINED WITH 125I BRACHYTHERAPY FOR THE TREATMENT OF MALIGNANT OBSTRUCTIVE JAUNDICE" CANCER IMAGING (2023) 23:33; DOI.ORG/10.1186/S40644-023-00551-0. IMDRF PATIENT CODE E1002 CAPTURES THE REPORTED PATIENT COMPLICATION OF ABDOMINAL PAIN. IMDRF PATIENT CODE E172001 CAPTURES THE REPORTED PATIENT COMPLICATION OF LIVER ABSCESS. IMDRF PATIENT CODE E1109 CAPTURES THE REPORTED PATIENT COMPLICATION OF CHOLANGITIS. IMDRF PATIENT CODE E233701 CAPTURES THE REPORTED PATIENT COMPLICATION OF RESTENOSIS. IMDRF IMPACT CODE F2303 CAPTURES THE MEDICATIONS USED TO TREAT THE LIVER ABSCESS AND PATIENT'S ABDOMINAL PAIN. IMDRF IMPACT CODE F23 CAPTURES THE REINTERVENTION TO TREAT THE RESTENOSIS.

    Description of Event or Problem · 0

    BOSTON SCIENTIFIC BECAME AWARE OF THE FOLLOWING EVENT THAT INVOLVES A WALLSTENT BILIARY UNCOVERED STENT THROUGH AN ARTICLE TITLED, "SAFETY AND EFFICACY OF SELF-EXPANDABLE METALLIC STENT COMBINED WITH 125I BRACHYTHERAPY FOR THE TREATMENT OF MALIGNANT OBSTRUCTIVE JAUNDICE" BY, HAN QI, ET AL. THE STUDY AIMED TO FURTHER EVALUATE THE SAFETY AND EFFICACY OF SEMS COMBINED WITH BRACHYTHERAPY IN THE MANAGEMENT OF UNRESECTABLE MALIGNANT OBSTRUCTIVE JAUNDICE (MOJ). A COMPREHENSIVE SEARCH WAS CONDUCTED BETWEEN (B)(6), 2021. THERE WERE 137 PATIENTS DIAGNOSED WITH MALIGNANT OBSTRUCTIONS. SEVENTY- EIGHT PATIENTS WERE ELIMINATED FROM THE STUDY DUE TO THE FOLLOWING: PREVIOUS BILIARY INTERVENTIONAL TREATMENT BEFORE ADMISSION, PATIENTS WITH ENDOSCOPIC OR PERCUTANEOUS BILIARY DRAINAGE WITHOUT STENT PLACEMENT AND INCOMPLETE MEDICAL RECORDS AND LOST FOLLOW UP. AMONG THE 59 PATIENTS INCLUDED (39 MEN AND 20 WOMEN), 34 PATIENTS CHOSE THE COMBINED THERAPY (125I BRACHYTHERAPY GROUP) INCLUDING 20 PATIENTS UNDERWENT STENT PLACEMENT WITH INTRALUMINAL 125I SEED STRAND INSERTION, AND 14 UNDERWENT STENT PLACEMENT WITH INTRATUMORAL 125I SEED IMPLANTATION UNDER CT-GUIDANCE. TWENTY-FIVE PATIENTS WERE TREATED WITH THE BILIARY STENT ALONE (THE CONTROL GROUP). THE ETIOLOGIES INCLUDED CHOLANGIOCARCINOMA (N=22), HEPATOCELLULAR CARCINOMA (N=13), AND METASTASES ASSOCIATED WITH DIFFERENT MALIGNANCIES (N=23). THE OBSTRUCTION SITE WAS THE HILAR BILIARY TRACT IN 52 INDIVIDUALS AND THE INTERMEDIATE AND DISTAL BILIARY TRACT IN 7 INDIVIDUALS. THE CLINICAL SUCCESS RATE WAS 94% (32/34) IN THE BRACHYTHERAPY GROUP AND 92% (23/25) IN THE CONTROL GROUP. AMONG THE FOUR INDIVIDUALS WHO FAILED TO ACHIEVE CLINICAL SUCCESS, ONE IN THE BRACHYTHERAPY GROUP WHO DEVELOPED LIVER ABSCESS RECEIVED ANTI-INFECTIVE THERAPY (WITH ANTIBIOTICS), TWO WITH POST-PROCEDURE CHOLANGITIS (ONE IN THE BRACHYTHERAPY GROUP AND THE OTHER ONE IN THE CONTROL GROUP) WERE TREATED MEDICALLY, AND THE OTHER PATIENT IN THE CONTROL GROUP UNDERWENT REINTERVENTION BECAUSE OF STENT RESTENOSIS. NO PROCEDURE-RELATED MAJOR COMPLICATIONS WERE OBSERVED IN THE 125I BRACHYTHERAPY GROUP AND THE CONTROL GROUP. SEVERE ABDOMINAL PAIN WAS NOTED IN FIVE PATIENTS IN THE TWO GROUPS WHICH WAS RELIEVED AFTER TAKING ANALGESICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1009428 WALLSTENT BILIARY CATHETER, BILIARY, DIAGNOSTIC MUM BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention