BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OBSIDIO

    MDR report key: 23656017 · Received November 26, 2025

    Report

    Report Number
    2124215-2025-82797
    Event Type
    Injury
    Date Received
    November 26, 2025
    Date of Event
    May 1, 2023
    Report Date
    November 26, 2025
    Manufacturer
    OBSIDIO, INC.
    Product Code
    KRD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: GAD S, DU PISANIE L, MOHNASKY M, HARRIS B, VILLALOBOS A, KEEFE N, MODY P, CADDELL A, KOKABI N. EARLY EXPERIENCE USING TANTALUM-LOADED NANOCOMPOSITE HYDROGEL CONFORMABLE EMBOLIC FOR UPPER GASTROINTESTINAL BLEEDING-OPEN-SANDWICH TECHNIQUE. J CLIN MED. 2025 MAR 29;14(7):2345. DOI: 10.3390/JCM14072345. PMID: 40217796; PMCID: PMC11989852. A. PATIENT INFORMATION: TEN PATIENTS WITH AVERAGE AGE OF 67.3 +/- 15.2 YEARS, 20% WERE FEMALE B3: DATE OF EVENT: APPROXIMATED BASED ON ARTICLE NOTING PATIENTS WHO UNDERWENT GDA EMBOLIZATION FOR UGIB USING TA-OCE BETWEEN MAY 2023 AND JUNE 2024. D6A IMPLANT DATE: APPROXIMATED BASED ON ARTICLE NOTING PATIENTS WHO UNDERWENT GDA EMBOLIZATION FOR UGIB USING TA-OCE BETWEEN MAY 2023 AND JUNE 2024. DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. BASED ON THE NATURE OF THE INFORMATION PROVIDED TO BSC, IT IS NOT POSSIBLE TO PERFORM A GOOD FAITH EFFORT TO OBTAIN ADDITIONAL INFORMATION. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INSUFFICIENT FORMATION OCCURRED, RESULTING IN REBLEEDING, REQUIRING INTERVENTION. A RETROSPECTIVE OBSERVATIONAL STUDY WAS PERFORMED TO EVALUATE THE EFFICACY AND SAFETY OF USING TANTALUM LOADED OBSIDIO CONFORMABLE EMBOLIC (TA-OCE) IN GASTRODUODENAL ARTERY (GDA) EMBOLIZATION FOR UPPER GASTROINTESTINAL BLEEDING (UGIB), EMPLOYING AN OPEN-SANDWICH TECHNIQUE. OBSIDIO CONFORMABLE EMBOLIC WAS USED IN 10 PATIENTS WITH CONFIRMED GDA BLEED ON ENDOSCOPY. TWO PATIENTS EXPERIENCED REBLEEDING WITHIN 24 HOURS, AS INDICATED BY POSITIVE ANGIOGRAPHIC FINDINGS. IN THESE TWO CASES, INADEQUATE EMBOLIZATION WAS PERFORMED. THE GDA WAS NOT OCCLUDED PROXIMALLY TO ITS ORIGIN IN ONE PATIENT, LEADING TO REBLEEDING WHICH WAS SUBSEQUENTLY EMBOLIZED WITH COILS. THE SECOND PATIENT REQUIRED A SECOND EMBOLIZATION TO ADDRESS COLLATERAL FLOW FROM THE PANCREATICO DUODENAL ARCADE. THIS WAS THOUGHT TO BE DUE TO INADEQUATE DISTAL PLACEMENT OF THE BACKSTOP COIL INTO THE PROXIMAL RIGHT GASTROEPIPLOIC ARTERY (RGEA).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1946552 OBSIDIO VASCULAR EMBOLIZATION DEVICE KRD OBSIDIO, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention