BEUDAMED
    FDA Adverse Event Injury Summary report: N

    Y-90 THERASPHERE

    MDR report key: 15998350 · Received December 16, 2022

    Report

    Report Number
    2124215-2022-52782
    Event Type
    Injury
    Date Received
    December 16, 2022
    Date of Event
    July 1, 2022
    Report Date
    February 6, 2023
    Manufacturer
    BIOCOMPATIBLES UK LIMITED
    Product Code
    NAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER ADDRESS 1: (B)(4). MFR SITE ADDRESS 1: MFR SITE ZIP/POST CODE:

    Additional Manufacturer Narrative · 0

    (B)(6).

    Description of Event or Problem · 0

    PROACTIF CLINICAL STUDY IT WAS REPORTED THAT THIS PATIENT WAS HOSPITALIZED FOR HEPATIC ABSCESS AND ESOPHAGEAL FISTULA SECONDARY TO TREATMENT. ON (B)(6) 2022, THE SUBJECT WAS ENROLLED INTO THE PROACTIF STUDY AND THE TREATMENT WITH THERASPHERE WAS PERFORMED ON THE SAME DAY TO THE LEFT LIVER. THE THERASPHERE INFUSION OF 1.87 GBQ WAS ADMINISTERED THROUGH LEFT HEPATIC ARTERY WITHOUT FLOW TO MEDIAL LOBE (SEGMENTS II/III). POST-TREATMENT DOSIMETRY RESULTS WERE NOT DETERMINED. ON (B)(6) 2022, 44 DAYS POST-INDEX PROCEDURE, SITE REPORTED AN EVENT OF HEPATIC ABSCESS. ON (B)(6) 2022, THE SUBJECT WAS HOSPITALIZED RELATED TO HEPATIC ABSCESS AND ESOPHAGEAL FISTULA SECONDARY TO TREATMENT WITH THERASPHERE EMBOLIZATION WAS NOTED. THE CORRECTIVE ACTION TAKEN, WAS TREATMENT WITH MEDICATION AND SURGERY OR INTERVENTIONAL RADIOLOGY PROCEDURE WAS ALSO PERFORMED. ON (B)(6) 2022, THE EVENT WAS CONSIDERED RESOLVED.

    Description of Event or Problem · 0

    PROACTIF CLINICAL STUDY IT WAS REPORTED THAT THIS PATIENT WAS HOSPITALIZED FOR HEPATIC ABSCESS AND ESOPHAGEAL FISTULA SECONDARY TO TREATMENT. ON 18-MAY-2022, THE SUBJECT WAS ENROLLED INTO THE PROACTIF STUDY AND THE TREATMENT WITH THERASPHERE WAS PERFORMED ON THE SAME DAY TO THE LEFT LIVER. THE THERASPHERE INFUSION OF 1.87 GBQ WAS ADMINISTERED THROUGH LEFT HEPATIC ARTERY WITHOUT FLOW TO MEDIAL LOBE (SEGMENTS II/III). POST-TREATMENT DOSIMETRY RESULTS WERE NOT DETERMINED. ON (B)(6) 2022 44 DAYS POST-INDEX PROCEDURE, SITE REPORTED AN EVENT OF HEPATIC ABSCESS. ON (B)(6) 2022 THE SUBJECT WAS HOSPITALIZED RELATED TO HEPATIC ABSCESS AND ESOPHAGEAL FISTULA SECONDARY TO TREATMENT WITH THERASPHERE EMBOLIZATION WAS NOTED. THE CORRECTIVE ACTION TAKEN, WAS TREATMENT WITH MEDICATION AND SURGERY OR INTERVENTIONAL RADIOLOGY PROCEDURE WAS ALSO PERFORMED. ON (B)(6) 2022 THE EVENT WAS CONSIDERED RESOLVED. UPON REVIEW OF THE RADIOLOGICAL IMAGES ON (B)(6) 2022 THE RADIOLOGIST HAD IDENTIFIED AN ARTERIAL BRANCH TO THE LOWER 1/3 OF THE ESOPHAGUS ORIGINATED FROM THE LEFT HEPATIC ARTERY. THE RADIOLOGIST ADMINISTERED THERASPHERE UPSTREAM OF THIS EMERGENCE AND, AS A RESULT THE MICROSPHERES HAVE CAUSED A RADIATION NECROSIS OF THE ESOPHAGUS. IT WAS NOTED THAT THE PATIENT HAS A HUGE TUMOR WITH HIGH UPTAKE OF MAA/Y90, AND AS A RESULT A TINY DEPOSITION COULD HAVE BEEN MISSED. THE ESOPHAGEAL NECROSIS WAS ON 2/3 OF THE CIRCUMFERENCE OF THE LOWER ESOPHAGUS FROM 36 TO 39 CM OF THE DENTAL ARCHES. NO FISTULA WAS SEEN IN FIBROSCOPY, HOWEVER, WAS DESCRIBED ON RADIOLOGICAL EXAMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2011095 Y-90 THERASPHERE MICROSPHERES RADIONUCLIDE NAW BIOCOMPATIBLES UK LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Required Intervention| H