BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLSTENT BILIARY

    MDR report key: 19556764 · Received June 18, 2024

    Report

    Report Number
    3005099803-2024-02902
    Event Type
    Malfunction
    Date Received
    June 18, 2024
    Date of Event
    April 4, 2023
    Report Date
    June 17, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MUM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: 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 E1: INITIAL REPORTER'S HEALTH CARE FACILITY NAME: SUN YAT-SEN UNIVERSITY CANCER CENTER AND SUN YAT-SEN UNIVERSITY STATE KEY LABORATORY OF ONCOLOGY IN SOUTH CHINA. 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. BLOCK H6: IMDRF DEVICE CODE A010402 CAPTURES THE REPORTABLE EVENT OF STENT MIGRATION.

    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) 2018, TO (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. ACCORDING TO THE LITERATURE, STENT OR SEED STRAND MIGRATION IN THE 125I BRACHYTHERAPY DEVELOPED IN ONE PATIENT (1.7%). CONSIDERING THAT THE DISLOCATED SEED STRAND STILL COVERED MOST OF THE STENOSIS SITE, A REINTERVENTION PROCEDURE WAS NOT PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1650905 WALLSTENT BILIARY CATHETER, BILIARY, DIAGNOSTIC MUM BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown