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The following information was received fro … The following information was received from the State of Georgia via email:</br>Event Narrative: A patient was treated with Y-90 microspheres for cholangiocarcinoma. This was a bilateral disease that would require the treatment of both lobes of the liver. Significant tumor burden was in the central (segment IV) and medial sections. The medical team decided to treat the left lobe first as a result.</br>For the first treatment, 54.05 mCi was to be delivered to the left lobe. It had an expected dose of 69.0 Gy to the liver. Due to issues with hepatic arterial anatomy not previously anticipated, the medical team could not properly position the catheter. Because it was a bilateral disease that would eventually require the treatment of both lobes, they decided to move forward with the procedure. </br>Of the calibrated activity of 52.6 mCi, a post-therapy survey of the vial showed 88% of the dose or 46.3 mCi was delivered. A post-delivery Bremsstrahlung scan showed excellent coverage of Segment IV, with some minor coverage in the right lobe due to the arterial anatomy. 21.8 mCi was localized to Segment IV, and the approximate remainder, 24.5 mCi, ended up in the right lobe. There was no significant extrahepatic activity seen.</br>The medical team considered the treatment to be successful due to the patient's bilateral disease. The authorized user intended to treat the right lobe next, and the team reports that the treatment plan will be adjusted to take into account the diseased areas which were treated. There should be no adverse reaction from this initial treatment.</br>Cause and Corrective Actions: Occurred due to an arterial aberration causing a the interventional radiologist to be unable to canulate the artery. The hepatic arterial anatomy was different the day of treatment than the initial shunt study suggested on 5 February 2014. The patient's medical team decided to proceed with the catheter orifice just at the origin of the segment IV hepatic artery. The shunt fractions then resulted differently from the intended treatment for that day.</br>The medical team and RSO are continuing to discuss if any preventative actions can be achieved. Treatment with Y-90 microspheres is reported to be complicated by the degree that the disease and prior treatments have affected liver vasculature. This makes it hard to plan for these scenarios pre-treatment. </br>Generic Implications: Post treatment scans for Y-90 were reported by the licensee not to be a common practice, but they seem vital for determining if a treatment meets reportable limits. </br>Procedure Administered: Bilateral radioembolization of liver with Y-90 microspheres.</br>Intended Dose: 54.05 mCi (69.0 Gy) to left lobe of liver.</br>Actual Dose: 21.8 mCi to Segment IV of left lobe and 24.5 mCi to the right lobe.</br>Patient and Referring Physician Notified: Informed following the procedure's post-delivery Bremsstrahlung scan.</br>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.necessarily result in harm to the patient.
04:00:00, 27 February 2014 +
49,917 +
16:48:00, 14 March 2014 +
04:00:00, 27 February 2014 +
The following information was received fro … The following information was received from the State of Georgia via email:</br>Event Narrative: A patient was treated with Y-90 microspheres for cholangiocarcinoma. This was a bilateral disease that would require the treatment of both lobes of the liver. Significant tumor burden was in the central (segment IV) and medial sections. The medical team decided to treat the left lobe first as a result.</br>For the first treatment, 54.05 mCi was to be delivered to the left lobe. It had an expected dose of 69.0 Gy to the liver. Due to issues with hepatic arterial anatomy not previously anticipated, the medical team could not properly position the catheter. Because it was a bilateral disease that would eventually require the treatment of both lobes, they decided to move forward with the procedure. </br>Of the calibrated activity of 52.6 mCi, a post-therapy survey of the vial showed 88% of the dose or 46.3 mCi was delivered. A post-delivery Bremsstrahlung scan showed excellent coverage of Segment IV, with some minor coverage in the right lobe due to the arterial anatomy. 21.8 mCi was localized to Segment IV, and the approximate remainder, 24.5 mCi, ended up in the right lobe. There was no significant extrahepatic activity seen.</br>The medical team considered the treatment to be successful due to the patient's bilateral disease. The authorized user intended to treat the right lobe next, and the team reports that the treatment plan will be adjusted to take into account the diseased areas which were treated. There should be no adverse reaction from this initial treatment.</br>Cause and Corrective Actions: Occurred due to an arterial aberration causing a the interventional radiologist to be unable to canulate the artery. The hepatic arterial anatomy was different the day of treatment than the initial shunt study suggested on 5 February 2014. The patient's medical team decided to proceed with the catheter orifice just at the origin of the segment IV hepatic artery. The shunt fractions then resulted differently from the intended treatment for that day.</br>The medical team and RSO are continuing to discuss if any preventative actions can be achieved. Treatment with Y-90 microspheres is reported to be complicated by the degree that the disease and prior treatments have affected liver vasculature. This makes it hard to plan for these scenarios pre-treatment. </br>Generic Implications: Post treatment scans for Y-90 were reported by the licensee not to be a common practice, but they seem vital for determining if a treatment meets reportable limits. </br>Procedure Administered: Bilateral radioembolization of liver with Y-90 microspheres.</br>Intended Dose: 54.05 mCi (69.0 Gy) to left lobe of liver.</br>Actual Dose: 21.8 mCi to Segment IV of left lobe and 24.5 mCi to the right lobe.</br>Patient and Referring Physician Notified: Informed following the procedure's post-delivery Bremsstrahlung scan.</br>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.necessarily result in harm to the patient.
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Y-90 + and Yttrium 90 +
00:00:00, 14 March 2014 +
GA 153-1 +
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23:09:37, 24 November 2018 +
16:48:00, 14 March 2014 +
15.575 d (373.8 hours, 2.225 weeks, 0.512 months) +
04:00:00, 27 February 2014 +
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