The following information was provided by the
Illinois Emergency Management Agency (the Agency) via phone and email:
On December 4, 2024, while administering Y-90 microspheres to a patient for radioembolization of the liver, a portion was shunted to the gastrointestinal tract. The shunting was not identified in the licensee's pre-administration macroaggregated albumin (MAA) mapping. The shunting is estimated to have resulted in approximately 100 cGy (rem) to the patient's stomach. The patient and physician have been notified. The licensee has not been reachable for additional details and a site visit is being coordinated.
- * * RETRACTION ON 12/16/2024 AT 1448 FROM GARY FORSEE TO IAN HOWARD * * *
The Agency conducted a reactive inspection on 12/11/24. Inspectors spoke with the authorized user (AU) to determine if shunting to non-treatment sites had been assessed in advance of the administration in accordance with the manufacturer's instructions. Proper shunting calculations had been performed for the lung and no additional non-treatment sites were identified. The licensee had performed an angiogram to evaluate GI flow on the day of procedure with nothing unique noted. Specifically, no GI flow was observed. The AU continued with administration to segment 4 of the liver using a Progreat 2.4Fr by 130 cm microcatheter, lot numbers: 240701 (exp. 6/30/26) and 240619 (exp. 5/31/26). No pressure, blockage or other abnormalities were encountered during administration. Nothing new or unique about the target or delivery was reported or identified. However, upon performing post-administration PET scans, uptake to the stomach was observed. The Agency has seen an increased number of licensees performing post administration PET scans and as a result, licensees are now able to visualize shunting to other organs. For example, in this case, without the post administration scan, the uptake to the stomach would not be known.
The inspector's reactive inspection memorandum is pending and this report will be updated with additional details. However, at this point, both the physician and the inspectors believe the shunting to the stomach was due to the vasculature of the patient and not improper catheter placement. As a result, this medical event is being requested for retraction. This report is being kept open pending addition of the inspector's detailed findings.
Notified R3DO (Stoedter), NMSS (Allen), and NMSS Events Notification (Email)
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.