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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIRTEX TECHNOLOGY PTY LTD SIR-SPHERES® Y-90 RESIN MICROSPHERES; MICEOSPHERES
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SIRTEX TECHNOLOGY PTY LTD SIR-SPHERES® Y-90 RESIN MICROSPHERES; MICEOSPHERES Back to Search Results
Lot Number NI403V09
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fall (1848); Fatigue (1849); Pain (1994); Cognitive Changes (2551); Confusion/ Disorientation (2553)
Event Date 11/13/2019
Event Type  Injury  
Manufacturer Narrative
The adverse events of general physical health deterioration and neurological disorder nos were classified as serious since they led to hospitalization of a (b)(6) year old male patient about 2 months after implantation of sir-spheres and 8 days after last administration of chemotherapy.Both events are unexpected for sir-spheres microspheres, related procedures and chemotherapy.The temporal relationship is considered plausible for cisplatin and sir-spheres microspheres and implausible for related procedures and gemcitabine, considering its short elimination half-life.The elderly patient presented to hospital with general status deterioration and unspecified neurological disorders and an egg was consistent with metabolic or toxic encephalopathy.Laboratory investigations show increasing bilirubin alkaline phosphatase and gamma glutamyl transpeptidase levels but overall, exploration of neurological disorders did not reveal a cause for the patient's confusion.Based on the information available no definite cause for the neurological disorder and general physical health deterioration could be identified but of note the patient was treated successfully with methylprednisolone.The investigator assessed the events as not related to sir-spheres microspheres, related procedure and chemotherapy.Based on the limited information available, the sponsor concurs and assesses both events as unlikely related to sir-spheres microspheres and cisplatin and not related to procedures and chemotherapy.With follow-up information received on 19-dec-2019 the investigator changed his causality assessment for the event general physical health deterioration to possibly related to chemotherapy (verbatim: perhaps due to chemotherapy).In addition, neurological disorder was specified as cognitive disorder with space-time disorientation during the night although the exact diagnosis remains unknown.No further details on the event general physical health deterioration was provided but of note asthenia and malaise are known side effects of chemotherapy.Overall, the information available is limited and it remains unclear how reduced general state exactly manifested and whether the neurological disorder may have occurred secondary to reduced general state.Based on the currently available information, the sponsor assesses a contributing role of chemotherapy to the event general physical health deterioration as possible.The event remains assessed as unlikely related to sir-spheres microspheres and not related to the procedures.Neurological disorder is assessed as unlikely related to chemotherapy and sir-spheres microspheres and not related to the procedures.With follow-up information received on 31-jan-2020 the event term neurological disorder nos was amended to cognitive disorder, which is also unexpected for sir-spheres microspheres, related procedures and chemotherapy.In addition, it was clarified that general status deterioration occurred probably in the context of reild (see also linked case (b)(4)).Since reild is expected for sir-spheres microspheres, in this case the event general status deterioration as symptom of reild is considered as expected as well for sir-spheres microspheres.According to this linked case the patient also suffered from concurrently occurring encephalopathy, which the investigator also considered as related to sir-spheres microspheres.However, as it remains unclear whether the cognitive disorder was an early symptom thereof or an independent episode since the outcome of cognitive disorder had been reported to be resolved, the causality assessment remains unchanged.Based on the newly available information, the sponsor changes the causality of general physical health deterioration as related to sir-spheres microspheres, not related to procedures and unlikely related to chemotherapy.
 
Event Description
This report combines information received on 03-dec-2019, 19-dec-2019 and 31-jan-2020.This case report became reportable with follow-up information received on 31-jan-2020.A serious adverse event report, (case number (b)(4)), was received from an investigator in (b)(6) regarding a male patient (patient no.(b)(6)) enrolled in "a prospective, multicentre, randomised, controlled study evaluating sir-spheres® y-90 resin microspheres preceding standard cisplatin-gemcitabine (cis-gem) chemotherapy versus cis-gem chemotherapy alone as first-line treatment of patients with unresectable intrahepatic cholangiocarcinoma (sircca)", study code stx0115.Initial report was received on 03-dec-2019: the reported event terms were general status deterioration and neurological disorders.At the time of the event onset the patient was (b)(6) year-old.The patient's medical history was significant for unresectable intrahepatic cholangiocarcinoma, cardiac arrhythmia, diagnosed on (b)(6) 2004, and high blood pressure, all ongoing.The patient received a combined treatment modality of sir-spheres microspheres + cis-gem chemotherapy.Mapping procedure was performed on (b)(6) 2019.Implantation of sir-spheres microspheres (1.87 gbq, batch no.Ni403v09) was performed on (b)(6) 2019 via right and left hepatic arteries.The event occurred during chemotherapy cycle 03 started on (b)(6) 2019.The second administration was not yet performed.On (b)(6) 2019, the patient was hospitalised for general status deterioration and neurological disorders.The events were severe.For laboratory values please see structured information.An eeg, performed on (b)(6) 2019, showed a "globally slowed electrogenesis consistent with metabolic or toxic encephalopathy".Results of a lumbar puncture were negative.Neurological disorders were explored but no response could be found to explain the patient's confusion.The patient was treated with methylprednisolone with success.Furthermore, the patient received oxycontin lp (oxycodone hydrochloride), 15 times 2mg daily, per oral from (b)(6) 2019, oxycodone, 0.4 mg/h daily, intravenously, from (b)(6) 2019 and oxycodone, 10 times 2 mg and 1.6 times 5 mg per day, per oral since (b)(6) 2019, all against pain.At the time of the report, the events were ongoing.Follow-up information was received on 19-dec-2019: the investigator confirmed that start date for both events was (b)(6) 2019.The neurological disorder was specified as cognitive disorder, exact diagnosis unknown, and space-time disorientation during the night, but improved with cortico-therapy.Abdominal pain was due to underlying disease, and buttock pain was due to falls.General status deterioration was perhaps due to chemotherapy cycles and was improved until discharge.The outcome was reported as recovered for both events.The patient was discharged from hospital on (b)(6) 2019 with no more neurological disorder and general status improvement.Follow-up information was received on 31-jan-2020: general status deterioration manifested as the patient being very tired, confused and disoriented.The neurological disorder was not considered as a possible secondary effect to general status deterioration.Since the neurological disorder was previously specified as cognitive disorder, the sae term was changed to "cognitive disorder".The final cause for general status deterioration was provided as not related to chemotherapy but as probably related to a beginning radioembolisation induced liver disease.Reporter's comment: the investigator assessed the event as not related to sir-spheres microspheres (mapping and implant procedures and device) or chemotherapy.With follow-up information received on 31-jan-2020 the investigator changed the sae of "neurological disorders" to "cognitive disorder", which was assessed as not related to sir-spheres microspheres (mapping and implant procedures and device) or chemotherapy.The sae of general status deterioration was confirmed as not related to sir-spheres microspheres (mapping and implant procedures and device) or chemotherapy.
 
Manufacturer Narrative
The adverse events of general physical health deterioration and neurological disorder nos were classified as serious since they led to hospitalization of a 78-year old male patient about 2 months after implantation of sir-spheres and 8 days after last administration of chemotherapy.Both events are unexpected for sir-spheres microspheres, related procedures and chemotherapy.The temporal relationship is considered plausible for cisplatin and sir-spheres microspheres and implausible for related procedures and gemcitabine, considering its short elimination half-life.The elderly patient presented to hospital with general status deterioration and unspecified neurological disorders and an egg was consistent with metabolic or toxic encephalopathy.Laboratory investigations show increasing bilirubin alkaline phosphatase and gamma glutamyl transpeptidase levels but overall, exploration of neurological disorders did not reveal a cause for the patient's confusion.Based on the information available no definite cause for the neurological disorder and general physical health deterioration could be identified but of note the patient was treated successfully with methylprednisolone.The investigator assessed the events as not related to sir-spheres microspheres, related procedure and chemotherapy.Based on the limited information available, the sponsor concurs and assesses both events as unlikely related to sir-spheres microspheres and cisplatin and not related to procedures and chemotherapy.With follow-up information received on 19-dec-2019 the investigator changed his causality assessment for the event general physical health deterioration to possibly related to chemotherapy (verbatim: perhaps due to chemotherapy).In addition, neurological disorder was specified as cognitive disorder with space-time disorientation during the night although the exact diagnosis remains unknown.No further details on the event general physical health deterioration was provided but of note asthenia and malaise are known side effects of chemotherapy.Overall, the information available is limited and it remains unclear how reduced general state exactly manifested and whether the neurological disorder may have occurred secondary to reduced general state.Based on the currently available information, the sponsor assesses a contributing role of chemotherapy to the event general physical health deterioration as possible.The event remains assessed as unlikely related to sir-spheres microspheres and not related to the procedures.Neurological disorder is assessed as unlikely related to chemotherapy and sir-spheres microspheres and not related to the procedures.With follow-up information received on 31-jan-2020 the event term neurological disorder nos was amended to cognitive disorder, which is also unexpected for sir-spheres microspheres, related procedures and chemotherapy.In addition, it was clarified that general status deterioration occurred probably in the context of reild (see also linked case stx0115-2020-0002).Since reild is expected for sir-spheres microspheres, in this case the event general status deterioration as symptom of reild is considered as expected as well for sir-spheres microspheres.According to this linked case the patient also suffered from concurrently occurring encephalopathy, which the investigator also considered as related to sir-spheres microspheres.However, as it remains unclear whether the cognitive disorder was an early symptom thereof or an independent episode since the outcome of cognitive disorder had been reported to be resolved, the causality assessment remains unchanged.Based on the newly available information, the sponsor changes the causality of general physical health deterioration as related to sir-spheres microspheres, not related to procedures and unlikely related to chemotherapy.With follow-up information received on 09-mar-2020 it was clarified that the events were considered as symptoms of reild and hepatic encephalopathy, reported in the linked case stx0115-2020-0002, therefore this case will be nullified.As the underlying reild and hepatic encephalopathy are expected for sir-spheres microspheres, the events/ symptoms general physical health deterioration and cognitive disorder are considered expected for sir-spheres microspheres in this case.Based on the information, the event cognitive disorder is also assessed as possibly related to sir-spheres microspheres, as well as the general physical health deterioration.
 
Event Description
This report combines information received on 03-dec-2019, 19-dec-2019 and 31-jan-2020.This case report became reportable with follow-up information received on 31-jan-2020.A serious adverse event report, (case number (b)(4)), was received from an investigator in france regarding a male patient (patient no.03307-003) enrolled in "a prospective, multicentre, randomised, controlled study evaluating sir-spheres® y-90 resin microspheres preceding standard cisplatin-gemcitabine (cis-gem) chemotherapy versus cis-gem chemotherapy alone as first-line treatment of patients with unresectable intrahepatic cholangiocarcinoma (sircca)", study code (b)(4).Initial report was received on 03-dec-2019: the reported event terms were general status deterioration and neurological disorders.At the time of the event onset the patient was 78-year-old.The patient's medical history was significant for unresectable intrahepatic cholangiocarcinoma, cardiac arrhythmia, diagnosed on (b)(6) 2004, and high blood pressure, all ongoing.The patient received a combined treatment modality of sir-spheres microspheres + cis-gem chemotherapy.Mapping procedure was performed on (b)(6) 2019.Implantation of sir-spheres microspheres (1.87 gbq, batch no.Ni403v09) was performed on (b)(6) 2019 via right and left hepatic arteries.The event occurred during chemotherapy cycle 03 started on (b)(6) 2019.The second administration was not yet performed.On (b)(6) 2019, the patient was hospitalised for general status deterioration and neurological disorders.The events were severe.For laboratory values please see structured information.An eeg, performed on (b)(6) 2019, showed a "globally slowed electrogenesis consistent with metabolic or toxic encephalopathy".Results of a lumbar puncture were negative.Neurological disorders were explored but no response could be found to explain the patient's confusion.The patient was treated with methylprednisolone with success.Furthermore, the patient received oxycontin lp (oxycodone hydrochloride), 15 times 2mg daily, per oral from (b)(6) 2019, oxycodone, 0.4 mg/h daily, intravenously, from (b)(6) 2019 and oxycodone, 10 times 2 mg and 1.6 times 5 mg per day, per oral since 25-nov-2019, all against pain.At the time of the report, the events were ongoing.Follow-up information was received on 19-dec-2019: the investigator confirmed that start date for both events was (b)(6) 2019.The neurological disorder was specified as cognitive disorder, exact diagnosis unknown, and space-time disorientation during the night, but improved with cortico-therapy.Abdominal pain was due to underlying disease, and buttock pain was due to falls.General status deterioration was perhaps due to chemotherapy cycles and was improved until discharge.The outcome was reported as recovered for both events.The patient was discharged from hospital on (b)(6) 2019 with no more neurological disorder and general status improvement.Follow-up information was received on 31-jan-2020: general status deterioration manifested as the patient being very tired, confused and disoriented.The neurological disorder was not considered as a possible secondary effect to general status deterioration.Since the neurological disorder was previously specified as cognitive disorder, the sae term was changed to "cognitive disorder." the final cause for general status deterioration was provided as not related to chemotherapy but as probably related to a beginning radioembolisation induced liver disease.Follow-up information was received on 09-mar-2020: the investigator confirmed that the reported event of general status deterioration was to be considered as a symptom of reild, whereas the event of cognitive disorder was to be considered as a symptom of an (hepatic) encephalopathy.Since saes of reild and hepatic encephalopathy are already processed within linked case stx0115-2020-0002, information will be transferred to linked case and this case will be nullified after reporting.Reporter's comment: the investigator assessed the event as not related to sir-spheres microspheres (mapping and implant procedures and device) or chemotherapy.With follow-up information received on 31-jan-2020 the investigator changed the sae of "neurological disorders" to "cognitive disorder", which was assessed as not related to sir-spheres microspheres (mapping and implant procedures and device) or chemotherapy.The sae of general status deterioration was confirmed as not related to sir-spheres microspheres (mapping and implant procedures and device) or chemotherapy.
 
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Brand Name
SIR-SPHERES® Y-90 RESIN MICROSPHERES
Type of Device
MICEOSPHERES
Manufacturer (Section D)
SIRTEX TECHNOLOGY PTY LTD
shop 6
207 pacific highway
st leonards, 2065
AS  2065
MDR Report Key9738521
MDR Text Key193043282
Report Number3005579300-2020-00003
Device Sequence Number1
Product Code NAW
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,s
Type of Report Initial,Followup
Report Date 03/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Lot NumberNI403V09
Initial Date Manufacturer Received 01/31/2020
Initial Date FDA Received02/21/2020
Supplement Dates Manufacturer Received03/09/2020
Supplement Dates FDA Received03/17/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
CISPLATIN; CISPLATIN; GEMCITABINE; GEMCITABINE; OXYCODONE; OXYCODONE; OXYCONTIN LP; OXYCONTIN LP
Patient Outcome(s) Hospitalization;
Patient Age78 YR
Patient Weight72
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