BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLSTENT ENTERNAL PROSTHESIS

    MDR report key: 16126078 · Received January 9, 2023

    Report

    Report Number
    3005099803-2022-07880
    Event Type
    Injury
    Date Received
    January 9, 2023
    Date of Event
    January 1, 2015
    Report Date
    January 9, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MQR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: EXACT DATE UNKNOWN, EVENT OCCURRED BETWEEN (B)(6) 2015 TO (B)(6) 2020. LITERATURE SOURCE: RUBEN S-A., JOSE CARLOS I., BELEN MARTINEZ M., JOAN G., ET AL. EIJS-GUIDED GASTROENTEROSTOMY VERSUS DUODENAL SELF-EXPANDABLE METAL STENT FOR MALIGNANT GASTRIC OUTLET OBSTRUCTION: RESULTS FROM A NATIONWIDE MULTICENTER RETROSPECTIVE STUDY. GASTROINTESTINAL ENDOSCOPY; 2022; 96:1012-20. INITIAL REPORTER ADDRESS 1: (B)(6). (B)(4).

    Description of Event or Problem · 0

    BOSTON SCIENTIFIC CORPORATION BECAME AWARE OF THE FOLLOWING EVENT FROM REFERENCED LITERATURE ARTICLE "EUS-GUIDED GASTROENTEROSTOMY VERSUS DUODENAL SELF-EXPANDABLE METAL STENT FOR MALIGNANT GASTRIC OUTLET OBSTRUCTION: RESULTS FROM A NATIONWIDE MULTICENTER RETROSPECTIVE STUDY." ACCORDING TO THE LITERATURE, A WALLFLEX DUODENAL STENT WAS IMPLANTED TO TREAT A GASTRIC OUTLET OBSTRUCTION DURING A DUODENAL STENTING PROCEDURE PERFORMED ON AN UNKNOWN DATE. IT WAS REPORTED THAT THE PATIENT EXPERIENCED TUMOR IN OR OVERGROWTH, MIGRATION AND PANCREATITIS AND/OR CHOLANGITIS. UNSPECIFIED WALLFLEX MALFUNCTIONS OCCURRED DURING PATIENT SURVEILLANCE WHICH WERE TREATED WITH 1:1 PLACEMENT OF A SECOND WALLFLEX STENT, ENDOSCOPIC ULTRASOUND GUIDED GASTROENTEROSTOMY, AND SURGICAL GASTROJEJUNOSTOMY. IT WAS FURTHER REPORTS THAT THE PATIENT EXPERIENCED PERFORATION, WHICH WAS TREATED WITH PALLIATIVE CARE, SEVERE BLEEDING REQUIRING BLOOD TRANSFUSION AND ADMISSION TO THE INTENSIVE CARE UNIT. NOTE: IT WAS REPORTED THAT THE WALLFLEX ENTERAL STENT WAS INTENDED TO BE PLACED TO TREAT A GASTRIC OUTLET OBSTRUCTION. HOWEVER, PER THE THE WALLFLEX ENTERAL DUODENAL STENT WITH ANCHOR LOCK DELIVERY SYSTEM IS INDICATED FOR THE PALLIATIVE TREATMENT OF GASTRODUODENAL OBSTRUCTIONS PRODUCED BY MALIGNANT NEOPLASMS. THE WALLFLEX ENTERAL STENT IS NOT INDICATED TO BE IMPLANTED IN GASTRIC OUTLET OBSTRUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1424366 WALLSTENT ENTERNAL PROSTHESIS STENT, COLONIC, METALIC, EXPANDABLE MQR BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention