ENS 58096
ENS Event | |
|---|---|
17:39 Dec 19, 2025 | |
| Title | Medical Event |
| Event Description | The following information was provided by the licensee via phone and email:
A patient was treated for metastatic disease of the liver, involving bilobar treatments with Y-90 microspheres (TheraSpheres). The right lobe was treated on 11/18/25, without complication. The left lobe was treated on 12/19/25 (1239 EST) with 1.77 GBq (47.8 mCi) of Y-90 microspheres. Pre-treatment coil embolization of the accessory left hepatic artery coming from the left gastric artery was performed, to prevent gastric activity that was observed on the Tc-99m macroaggregated albumin (MAA) mapping study (11/4/25). Proper catheter placement in the hepatic artery was verified by digital subtraction angiography (DSA), and the Y-90 microspheres were administered. Following the standard of care for Y-90 microsphere administrations, single photon emission computed tomography (SPECT/CT) was performed after the administration to confirm proper distribution of the microspheres. Approximately 2 hours2.314815e-5 days <br />5.555556e-4 hours <br />3.306878e-6 weeks <br />7.61e-7 months <br /> post-administration (after the patient had been discharged), nuclear medicine physicians evaluating the SPECT/CT results notified the prescribing physician of abnormal uptake into the stomach wall and to a lesser extent the upper left quadrant (not organ-specific). Retrospective review (with enhancement) of DSA showed a possible small accessory right gastric artery branch that potentially provided a path for extrahepatic distribution of the Y-90 microspheres, though it is diminutive in size relative to the left hepatic artery and its branches (and was not expected to contribute to extraheptic uptake). However, this was not observable on the initial DSA (without enhancement). Initial estimates of the extrahepatic uptake were approximately 70 percent of the administered dose. The authorized user physician, authorized medical physicist, and radiation safety officer were immediately notified, and the prescribing physician contacted the patient to evaluate clinical status; the patient noted fatigue, decreased appetite, and some left upper quadrant pain. The prescribing physician informed the patient of the extrahepatic uptake (predominantly in the stomach) and asked the patient to return to the emergency department (ED) for examination. In the ED, the prescribing physician discussed plans for monitoring, administering a proton-pump inhibitor and sucralfate (Pepto) to ameliorate any developing gastritis, recommended avoiding non-steroidal anti-inflammatory drugs (NSAID), and instructed to return to the ED if any food intolerance (because the patient hadn't eaten since before the procedure) or worsening abdominal pain. The prescribing physician made arrangements to repeat SPECT/CT imaging at day 3 post-administration to confirm distribution of the microspheres and help determine the percentages distributed intra-hepatically and extrahepatically. Potential causes were (1) catheter placement within the left hepatic artery such that preferential flow went into the diminutive branch, which may provide flow to the stomach, (2) possible dislodgement or advancement of the catheter into the diminutive branch between angiogram confirmation within the larger left hepatic artery and Y-90 administration, resulting in dominant flow into the small accessory branch, or (3) catheter dislodgement after spot film (fluoroscopy) but prior to administration due to respiratory variation or tension. Of note, Tc-99m MAA administration on 11/4 (during treatment planning) did detect extrahepatic uptake to the stomach. This was initially credited to an accessory left hepatic artery (observed on CT-angiography and confirmed with angiography) and close proximity of supraduodenal and gastroduodenal arteries observed on angiography and intra-arterial liver CT-angiography. While treatment of these putative extrahepatic sources was performed prior to the administration of Y-90, there was no information or data to definitively exclude other potential collaterals that may result in extrahepatic distribution. All involved parties agreed that this event may meet the definition of a medical event in 35.3045(a)(2)(iii)(C) - and possibly (2)(i) and (2)(ii) - assuming the microspheres went directly into the stomach wall and were not implanted in the liver. Discussions of corrective actions are ongoing. The licensee will follow up with the required 15-day report. A Medical Event may indicate potential problems in a medical facility's use of radioactive materials. It does not necessarily result in harm to the patient. |
| Where | |
|---|---|
| University Of Michigan Hospital Ann Arbor, Michigan (NRC Region 3) | |
| License number: | 21-00215-04 |
| Organization: | University Of Michigan Hospital |
| Reporting | |
| 10 CFR 35.3045(a)(2)(iii) | |
| Time - Person (Reporting Time:+26.22 h1.093 days <br />0.156 weeks <br />0.0359 months <br />) | |
| Opened: | Karl Fischer 19:52 Dec 20, 2025 |
| NRC Officer: | Josue Ramirez |
| Last Updated: | Dec 20, 2025 |
| 58096 - NRC Website | |
University Of Michigan Hospital with 10 CFR 35.3045(a)(2)(iii) | |
WEEKMONTHYEARENS 580962025-12-19T17:39:00019 December 2025 17:39:00
[Table view]10 CFR 35.3045(a)(2)(iii) Medical Event 2025-12-19T17:39:00 | |