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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIRTEX TECHNOLOGY PTY LTD / SIRTEX MEDICAL LIMITED SIR-SPHERES® Y-90 RESIN MICROSPHERES
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SIRTEX TECHNOLOGY PTY LTD / SIRTEX MEDICAL LIMITED SIR-SPHERES® Y-90 RESIN MICROSPHERES Back to Search Results
Lot Number NA405V12
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abscess (1690); Neurological Deficit/Dysfunction (1982); Jaundice (2187); Ascites (2596); Test Result (2695); No Code Available (3191)
Event Date 04/23/2019
Event Type  Injury  
Manufacturer Narrative
The adverse event of hepatic decompensation was classified as serious since it required hospitalization of a (b)(6) male patient about 3 months after sir-spheres microspheres implantation and about 1 month after last administration of nivolumab.The event is expected for sir-spheres microspheres and unexpected for procedures as well as nivolumab.The temporal relationship is implausible for mapping and implant procedures and considered plausible for nivolumab due to its long elimination half-life (~25 days) and also considered plausible for sir-spheres microspheres taking into account latency time and cumulative effects.Noteworthy, the patient's underlying hepatocellular carcinoma provides a plausible explanation for the event and about 30 days prior to the hospitalization the patient terminated the study due to disease progression, which further supports a causal role of the underlying malignant disease.Of note, the initially reported increased bilirubin and increased alp and ggt in the linked case (b)(4) supports a contributing role of sir-spheres, although ast is usually not elevated as seen in this patient.The investigator assessed the event as possibly related to sir-spheres microspheres and did not specify the relationship regarding related procedures and nivolumab.Based on the information available, the sponsor assessed a contributing role of sir-spheres microspheres as possible and assessed the event as not related to procedures and nivolumab.
 
Event Description
This report combines information received on 28-apr-2019 and (b)(6) 2019.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 (b)(6).Initial report was received on 28-apr-2019.Initially the event term was "bilirubin elevation".With additional information received on (b)(6) 2019 the reported event term was changed to "liver decompensation".At the time of the event onset the patient was (b)(6).This case is linked to (b)(4) (sae of "anal abscess").The patient's medical history was significant for hepatocellular carcinoma.Concomitant medication was not reported.The patient received a combined treatment modality of sir-spheres microspheres + nivolumab chemotherapy.Implantation of sir-spheres microspheres was performed on (b)(6) 2019.Implanted activity of sir-spheres microspheres was 1.4 gbq, sublobar.Nivolumab, 240 mg, i.V., was started on (b)(6) 2019.Date of last nivolumab administration was reported as (b)(6) 2019.Study participation of the patient was terminated on (b)(6) 2019 due to disease progression.The patient presented with jaundice, choluria, acholia, and ascites.He showed analytical deterioration.On (b)(6) 2019 the patient was hospitalized for symptomatic treatment.Evacuation paracentesis was performed and albumin treatment was started.The event was severe.The patient was treated with rifaximin (edetate disodium), 400 mg, oral, every 8 h, starting on (b)(6) 2019, ongoing; and albumin (albumin), 20 g, every 8 h, starting on (b)(6) 2019, both for ascites.On (b)(6) 2019 the patient was discharged from hospital.The outcome was provided as resolved with sequelae.Reporter's comments: the investigator assessed the event as possibly related sir spheres microspheres (medical device), but did not specify the relatedness in regards to sir-spheres microspheres (mapping procedure and implant procedure) and nivolumab.
 
Event Description
A serious adverse event report, (case number: (b)(4), was received from an investigator in spain regarding a male patient (patient no: (b)(6) enrolled in "a multicenter, open-label, single-arm study of the safety and antitumoral efficacy of nivolumab after selective internal radiation therapy (sirt) using sir-spheres for the treatment of patients with hepatocellular carcinoma that are candidates for locoregional therapies (nasir-hcc)", study code: ca209-992.Initial report was received on 28-apr-2019.Initially the event term was "bilirubin elevation".With additional information received on 29-apr-2019 the reported event term was changed to "liver decompensation".At the time of the event onset the patient was 72-year-old.This case is linked to (b)(4) (sae of "anal abscess").The patient's medical history was significant for hepatocellular carcinoma.Concomitant medication was not reported.The patient received a combined treatment modality of sir-spheres microspheres + nivolumab chemotherapy.Implantation of sir-spheres microspheres was performed on (b)(6) 2019.Implanted activity of sir-spheres microspheres was 1.4 gbq, sublobar.Nivolumab, 240 mg, i.V., was started on (b)(6) 2019.Date of last (b)(6) administration was reported as on (b)(6) 2019.Study participation of the patient was terminated on (b)(6) 2019 due to disease progression.The patient presented with jaundice, choluria, acholia, and ascites.He showed analytical deterioration.On (b)(6) 2019, the patient was hospitalized for symptomatic treatment.Evacuation paracentesis was performed and albumin treatment was started.The event was severe.The patient was treated with rifaximin (edetate disodium), 400 mg, oral, every 8 h, starting on (b)(6) 2019, ongoing; and albumin (albumin), 20 g, every 8 h, starting on (b)(6) 2019 until on (b)(6) 2019, both for ascites.On (b)(6) 2019 the patient was discharged from hospital.The outcome was provided as resolved with sequelae.Follow-up information was received on 07-may-2019: sir-spheres microspheres mapping procedure was performed on (b)(6) 2019.Details on the dose of sir-spheres microspheres administration were reported as: "target liver volume was 650 ml and tumor volume was 50 ml".Nivolumab has been administered every two weeks.The patient's medical history was significant for a pre-existing liver disease specified as enolic cirrhosis with compensated portal hypertension.Hepatocellular carcinoma was treated with hepatectomy in 2013 prior to radioembolization.The following laboratory values were provided: baseline lab data on (b)(6) 2019: bilirubin 1.05, ggt 286 and alp 152 (no units provided).Lab data after insertion on (b)(6) 2019: bilirubin 1.2, ggt 268, alp 163 (no units provided).Follow-up information was received on 14-may-2019: further information on patient's medication was provided.Treatment with rifaximin was stopped on (b)(6) 2019, the indication was updated to ascites and liver decompensation.For treatment of liver decompensation the patient received prednisone 10 mg, daily, oral from on (b)(6) 2019 and ursobilane (ursodeoxycholic acid) 900 mg, every 8 hours from on (b)(6) 2019.Reporter's comments: the investigator assessed the event as possibly related sir spheres microspheres (medical device), but did not specify the relatedness in regards to sir-spheres microspheres (mapping procedure and implant procedure) and nivolumab.With follow-up information received on 07-may-2019, the investigator assessed the event as possibly related sir-spheres microspheres (medical device) and nivolumab but did not specify the relatedness in regard to sir-spheres mapping and implant procedure.With follow-up information received on 14-may-2019, the investigator assessed the event as not related to sir-spheres microspheres mapping and implant procedure.
 
Manufacturer Narrative
The adverse event of hepatic decompensation was classified as serious since it required hospitalization of a 72-year old male patient about 3 months after sir-spheres microspheres implantation and about 1 month after last administration of nivolumab.The event is expected for sir-spheres microspheres and unexpected for procedures as well as nivolumab.The temporal relationship is implausible for mapping and implant procedures and considered plausible for nivolumab due to its long elimination half-life (~25 days) and also considered plausible for sir-spheres microspheres taking into account latency time and cumulative effects.Noteworthy, the patient's underlying hepatocellular carcinoma provides a plausible explanation for the event and about 30 days prior to the hospitalization the patient terminated the study due to disease progression, which further supports a causal role of the underlying malignant disease.Of note, the initially reported increased bilirubin and increased alp and ggt in the linked case: (b)(4) supports a contributing role of sir-spheres, although ast is usually not elevated as seen in this patient.The investigator assessed the event as possibly related to sir-spheres microspheres and did not specify the relationship regarding related procedures and nivolumab.Based on the information available, the sponsor assessed a contributing role of sir-spheres microspheres as possible and assessed the event as not related to procedures and nivolumab.With follow-up information received on 07-may-2019 further laboratory values and details on the dose of sir-spheres microspheres and on the dose interval of nivolumab were provided.The patient has a pre-existing liver cirrhosis with compensated portal hypertension, which most likely contributed to the development of the event.The investigator assessed the causality of the event as possibly related to sir-spheres microspheres and nivolumab but did not specify the relationship regarding related procedures.Hepatic decompensation is formally unexpected for nivolumab, however according to the ib of nivolumab drug-induced liver injury may rarely occur.Thus, in view of the plausible temporal relationship and the plausible pharmacological mechanism the sponsor concurs and assesses the causality of the event as possibly related to sir-spheres microspheres and nivolumab.Thesponsor's causality assessment for the event remains unchanged as not related to the procedures.With follow-up report received on 14-may-2019 information on the treatment of the event was provided.Furthermore, the investigator assessed the causality of the event as not related to sir-spheres microspheres mapping and implant procedure, which supports the sponsor's causality assessment.
 
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Brand Name
SIR-SPHERES® Y-90 RESIN MICROSPHERES
Type of Device
MICROSPHERES
Manufacturer (Section D)
SIRTEX TECHNOLOGY PTY LTD / SIRTEX MEDICAL LIMITED
shop 6
207 pacific highway
st leonards, 2065
AS  2065
MDR Report Key8598436
MDR Text Key144672960
Report Number3005579300-2019-00002
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 05/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/10/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Lot NumberNA405V12
Date Manufacturer Received05/08/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
NIVOLUMAB
Patient Outcome(s) Hospitalization;
Patient Age72 YR
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