MAUDE Adverse Event Report: BIOCOMPATIBLES UK LTD THERASPHERE; YTTRIUM-90 GLASS MICROSPHERES, PRODUCT CODE: NAW

Model Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Death (1802); Encephalopathy (1833); Hepatitis (1897); Ascites (2596); Test Result (2695)

Event Type  Death  

Manufacturer Narrative

Btg medical assessment: a (b)(6) male patient with a centrally located cholangiocarcinoma in segment iv and intrahepatic metastases had disease progression after two lines of systemic chemotherapy and was referred for radioembolization.Ct and work-up angiography showed normal hepatic arterial anatomy and no arteries were coil embolized in this session.99mtc-maa was injected in the lha and rha.The lsf was negligible (3.5%), and spect/ct showed high deposition of activity in the segment iv tumor.During y90 angiography, a right gastric artery arising from the lha was newly visualized and embolized with microcoils: more distally in the lha, another gastric vessel was discovered, but could not be catheterized.Thus, the decision was made to move the injection position more distally in the lha, beyond the ostium of the gastric vessel, and to embolize the tumor feeding segment i branch arising proximally to the new injection position in the lha to achieve redistribution of blood flow into the left liver glass 90y microspheres were administered in the rha (3.4 gbq), glass 90y microspheres were administered in the lha (1.2 gbq).The average whole liver absorbed dose of 120 gy, because of the good tumor targeting on 99mtc-maa-spect/ct.However,90y-pet/ct revealed a poor tumor targeting and no redistribution of activity into segment i.Post-treatment dosimetry was performed on 90y-pet/ct and revealed that segment i received an absorbed dose of 19.5 gy, confirming the failure of redistribution.As a result of this, the (whole liver) average normal tissue absorbed dose was 125.3 gy, while the tumor absorbed dose was only 86.5 gy.The patient was discharged in a good clinical state.One month after treatment, the patient complained of increasing pain in the right side of the abdomen and therefore, ct and 18f-fdg-pet/ct was performed.At 2 months post-treatment, the tumor showed partial metabolic response on 18f-fdg-pet/ct.However, cect showed a hypodense aspect of the healthy liver, splenomegaly, and ascites.These findings are consistent with radioembolization-induced liver disease (reild).The patient also developed hepatic encephalopathy, with an increase in serum values of bilirubin had (from 10 to 64 umol/l), decrease in albumin (from 42.5 to 29.7 g/l), and increase in the inr (from 1 to 1.23).Four months after treatment, the patient died due to reild.In this case, 90y-pet/ct dosimetry showed that the tumor absorbed dose was low, even lower than the healthy liver dose.In addition, 90y-pet/ct demonstrated that the attempt to induce redistribution to segment i had failed.Reild was to be expected based on a 125 gy healthy liver absorbed dose.No batch review was possible for this case as the batch number(s) could not be ascertained and the product was not returned for evaluation (devices remain implanted in the patients and information was obtained via a literature review).No product malfunction/deficiency has been identified or reported.No corrective/preventative action has been identified.Should we receive any information to enable further investigations, a follow-up report will be submitted.At this time this report is considered final.

Event Description

Review of literature article: the value of yttrium-90 pet/ct after hepatic radioembolization:a pictorial essay.Authors: ahmed a alsultan et al.Case #4: 90y-pet/ct to assess the success of flow redistribution and prediction of reild.A (b)(6) male patient with a centrally located cholangiocarcinoma in segment iv and intrahepatic metastases had disease progression after two lines of systemic chemotherapy and was referred for radioembolization.Ct and work-up angiography showed normal hepatic arterial anatomy and no arteries were coil embolized in this session.99mtc-maa was injected in the lha and rha.The lsf was negligible (3.5%), and spect/ct showed high deposition of activity in the tumor.During y90 angiography, a previously undetected rga arising from the lha was visualized and decision was made to o embolize the tumor feeding segment i branch arising proximally to the new injection position in the lha to achieve redistribution of blood flow o glass 90y microspheres were administered in the lha (1.2 gbq).More distally in the lha, another gastric vessel was discovered, but could not be catheterized.Thus, the decision was made to move the injection position more distally in the lha, beyond the ostium of the gastric vessel, and (2) to embolize the tumor feeding segment i branch arising proximally to the new injection position in the lha to achieve redistribution of blood flow.O glass 90y microspheres were administered in the rha (3.4 gbq), the average whole liver absorbed dose of 120 gy, because of the good tumor targeting on 99mtc-maa-spect/ct.However,90y-pet/ct revealed a poor tumor targeting and no redistribution of activity into segment i.Post-treatment dosimetry was performed on 90y-pet/ct and revealed that segment i received an absorbed dose of 19.5 gy, confirming the failure of redistribution.As a result of this, the (whole liver) average normal tissue absorbed dose was 125.3 gy, while the tumor absorbed dose was only 86.5 gy.The patient was discharged in a good clinical state.One month after treatment, the patient complained of increasing pain in the right side of the abdomen and therefore, ct and 18f-fdg-pet/ct was performed.At 2 months post-treatment, the tumor showed partial metabolic response on 18f-fdg-pet/ct.However, cect showed a hypodense aspect of the healthy liver, splenomegaly, and ascites.These findings are consistent with radioembolization-induced liver disease (reild).The patient also developed hepatic encephalopathy, with an increase in serum values of bilirubin had (from 10 to 64 umol/l), decrease in albumin (from 42.5 to 29.7 g/l), and increase in the inr (from 1 to 1.23).Four months after treatment, the patient died due to reild.In this case, 90y-pet/ct dosimetry showed that the tumor absorbed dose was low, even lower than the healthy liver dose.In addition, 90y-pet/ct demonstrated that the attempt to induce redistribution to segment i had failed.Reild was to be expected based on a 125 gy healthy liver absorbed dose.Abdominal pain; ascites; hepatic encephalopathy; blood bilirubin increased; albumin decreased; inr increased; death and non-target distribution are anticipated events listed in the ifu/risk management documentation.

Event Description

Review of literature article: the value of yttrium-90 pet/ct after hepatic radioembolization:a pictorial essay.Authors: ahmed a alsultan et al.Case #4: 90y-pet/ct to assess the success of flow redistribution and prediction of reild.A 63-year-old male patient with a centrally located cholangiocarcinoma in segment iv and intrahepatic metastases had disease progression after two lines of systemic chemotherapy and was referred for radioembolization.Ct and work-up angiography showed normal hepatic arterial anatomy and no arteries were coil embolized in this session.99mtc-maa was injected in the lha and rha.The lsf was negligible (3.5%), and spect/ct showed high deposition of activity in the tumor.During y90 angiography, a previously undetected rga arising from the lha was visualized and decision was made to o embolize the tumor feeding segment i branch arising proximally to the new injection position in the lha to achieve redistribution of blood flow.O glass 90y microspheres were administered in the lha (1.2 gbq) more distally in the lha, another gastric vessel was discovered, but could not be catheterized.Thus, the decision was made to o move the injection position more distally in the lha, beyond the ostium of the gastric vessel, and (2) to embolize the tumor feeding segment i branch arising proximally to the new injection position in the lha to achieve redistribution of blood flow.O glass 90y microspheres were administered in the rha (3.4 gbq), the average whole liver absorbed dose of 120 gy, because of the good tumor targeting on 99mtc-maa-spect/ct.However,90y-pet/ct revealed a poor tumor targeting and no redistribution of activity into segment i.Post-treatment dosimetry was performed on 90y-pet/ct and revealed that segment i received an absorbed dose of 19.5 gy, confirming the failure of redistribution.As a result of this, the (whole liver) average normal tissue absorbed dose was 125.3 gy, while the tumor absorbed dose was only 86.5 gy.The patient was discharged in a good clinical state.One month after treatment, the patient complained of increasing pain in the right side of the abdomen and therefore, ct and 18f-fdg-pet/ct was performed.At 2 months post-treatment, the tumor showed partial metabolic response on 18f-fdg-pet/ct.However, cect showed a hypodense aspect of the healthy liver, splenomegaly, and ascites.These findings are consistent with radioembolization-induced liver disease (reild).The patient also developed hepatic encephalopathy, with an increase in serum values of bilirubin had (from 10 to 64 umol/l), decrease in albumin (from 42.5 to 29.7 g/l), and increase in the inr (from 1 to 1.23).Four months after treatment, the patient died due to reild.In this case, 90y-pet/ct dosimetry showed that the tumor absorbed dose was low, even lower than the healthy liver dose.In addition, 90y-pet/ct demonstrated that the attempt to induce redistribution to segment i had failed.Reild was to be expected based on a 125 gy healthy liver absorbed dose.Abdominal pain; ascites; hepatic encephalopathy; blood bilirubin increased; albumin decreased; inr increased; death and non-target distribution are anticipated events listed in the ifu/risk management documentation additional information received from author: 03-dec-2019; batch number 1699102, treatment date: (b)(6) 2016, perfused volume: right lobe, desired dose 120gy, ordered activity: 8500mgq, prescribed activity: 3350mgq, activity infused: 3017mbq, received dose: 2914mbq, perfused volume: left lobe, desired dose: 120gy, ordered activity: 3000mbq, prescribed activity:1170mbq, activity infused: 1094mbq, received dose:1062mbq.

Manufacturer Narrative

Additional information received from author included associated batch number.A device history review will be performed.Findings will be provided in a supplemental report.

Manufacturer Narrative

Device history records were reviewed 17-feb-2020 batch 1699102: a.No deviations were reported.B.Endotoxin testing results were <0.006 eu/mg; the limit is

• Brand Name: THERASPHERE
• Type of Device: YTTRIUM-90 GLASS MICROSPHERES, PRODUCT CODE: NAW
• Manufacturer (Section D): BIOCOMPATIBLES UK LTD; chapman house farnham bus park; weydon lane; farnham, GU9 8 QL; UK GU9 8QL
• MDR Report Key: 9346061
• MDR Text Key: 167112817
• Report Number: 3002124543-2019-00065
• Device Sequence Number: 1
• Product Code: NAW
• Combination Product (y/n): N
• PMA/PMN Number: H980006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup,Followup
• Report Date: 02/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 63 YR