MAUDE Adverse Event Report: SIRTEX TECHNOLOGY PTY LTD / SIRTEX MEDICAL LIMITED SIR-SPHERES® Y-90 RESIN MICROSPHERES

Lot Number NF45V10

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Abdominal Pain (1685); Nausea (1970); Vomiting (2144); Discomfort (2330)

Event Date 07/01/2019

Event Type  Injury  

Manufacturer Narrative

Sender's comments: the adverse event of vomiting was classified as serious due to hospitalization of a (b)(6) year old female patient 5 days after mapping procedure and on the day the implant procedure was conducted.No chemotherapy had been administered yet.Vomiting is expected for sir-spheres microspheres and implant procedure and unexpected for mapping procedure.The temporal relationship is implausible for the mapping procedure but plausible for implant procedure and sir-spheres microspheres.Already during the implant procedure, the patient started feeling nauseous and subsequently vomited.Although vomiting is a common side effect of the patient's concomitant medication including carvedilol, the temporal course is indicative for a causal role of implant procedures and sir-spheres microspheres.Therefore, the sponsor concurs with the investigator and assesses the event of vomiting as probably related to implant procedure and sir-spheres microspheres and as not related to mapping procedure.

Event Description

A serious adverse event report, (case number (b)(4)), was received from an investigator in (b)(6) regarding a female patient (patient no.(b)(6) enrolled in (b)(6).Initial report was received on 02-jul-2019.The reported event term was vomiting.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 and ischemic heart disease in 2006.Concomitant medication included adiro (acetylsalicylic acid) tablets, 100 mg daily, since 2006, for ischemic heart disease; coropres (carvedilol) tablets, 6.25 mg daily, since 2006, for ischemic heart disease; and trankimazin (alprazolam) tablets, 0.25 mg daily, since unknown date, for anxiety, 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 (1.24 gbq, batch no.Nf45v10) was performed on (b)(6) 2019 via intrahepatic artery.At the time of the event treatment with chemotherapy agents (cisplatin-gemcitabine) was not yet started.On (b)(6) 2019, the patient presented with vomiting and was hospitalized.During sir-spheres microspheres implantation the patient started with nausea and pain.Once the treatment had been finished, she was moved to the observation ward.The patient continued with pain (abdominal) and vomiting.Ondansetron and paracetamol were given but around 7 pm the patient was still feeling discomfort and pain.It was decided that the patient was hospitalized.On the next morning she was feeling better although still having had 2 episodes of vomiting.The event was of moderate severity.At the time of the report, the patient was recovering.Reporter's comments: the investigator assessed the event as not related to sir-spheres microspheres (mapping procedure) and as probably/likely related to sir-spheres microspheres (implant procedure) and sir-spheres microspheres (medical device).

Manufacturer Narrative

Sender's comments: the adverse event of vomiting was classified as serious due to hospitalization of a 67-year old female patient 5 days after mapping procedure and on the day the implant procedure was conducted.No chemotherapy had been administered yet.Vomiting is expected for sir-spheres microspheres and implant procedure and unexpected for mapping procedure.The temporal relationship is implausible for the mapping procedure but plausible for implant procedure and sir-spheres microspheres.Already during the implant procedure, the patient started feeling nauseous and subsequently vomited.Although vomiting is a common side effect of the patient's concomitant medication including carvedilol, the temporal course is indicative for a causal role of implant procedures and sir-spheres microspheres.Therefore, the sponsor concurs with the investigator and assesses the event of vomiting as probably related to implant procedure and sir-spheres microspheres and as not related to mapping procedure.With follow-up information received on 29-jul-2019 the serious event pain was added.Pain is unexpected for sir-spheres microspheres and related procedures but of note abdominal pain, to which pain likely refers considering the information provided in the initial report, is expected for sir-spheres microspheres and implant procedures.The temporal relationship is plausible for sir-spheres microspheres and implant procedure and implausible for the mapping procedure.Occurrence of abdominal pain after the implantation procedure is well known and initially it was reported that the patient suffered from vomiting and abdominal pain, thus it is likely that pain occurred in this context.The investigator did not provide a causality assessment for the newly added event of pain.Considering the information provided overall, the sponsor assesses pain as possibly related to implant procedure and sir-spheres microspheres and as not related to mapping procedure.Therefore, the sponsor concurs with the investigator and assesses the event of vomiting as probably related to implant procedure and sir-spheres microspheres and as not related to mapping procedure.

Event Description

A serious adverse event report, (case number (b)(4)), was received from an investigator in spain regarding a female 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 02-jul-2019.The reported event term was vomiting.At the time of the event onset the patient was 67-year-old.The patient's medical history was significant for unresectable intrahepatic cholangiocarcinoma and ischemic heart disease in 2006.Concomitant medication included adiro (acetylsalicylic acid) tablets, 100 mg daily, since 2006, for ischemic heart disease; coropres (carvedilol) tablets, 6.25 mg daily, since 2006, for ischemic heart disease; and trankimazin (alprazolam) tablets, 0.25 mg daily , since unknown date, for anxiety, 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 (1.24 gbq, batch no.Nf45v10) was performed on (b)(6) 2019 via intrahepatic artery.At the time of the event treatment with chemotherapy agents (cisplatin-gemcitabine) was not yet started.On (b)(6) 2019, the patient presented with vomiting and was hospitalized.During sir-spheres microspheres implantation the patient started with nausea and pain.Once the treatment had been finished, she was moved to the observation ward.The patient continued with pain (abdominal) and vomiting.Ondansetron and paracetamol were given but around 7 pm the patient was still feeling discomfort and pain.It was decided that the patient was hospitalized.On the next morning she was feeling better although still having had 2 episodes of vomiting.The event was of moderate severity.At the time of the report, the patient was recovering.Follow-up information was received on 29-jul-2019: the event of vomiting stopped on (b)(6) 2019.The investigator confirmed that pain was considered as additional sae.No further information was provided.Reporter's comments: the investigator assessed the event as not related to sir-spheres microspheres (mapping procedure) and as probably/likely related to sir-spheres microspheres (implant procedure) and sir-spheres microspheres (medical device).Follow-up information received on 29-jul-2019: the investigator did not provide a causality assessment for the event of pain.

Manufacturer Narrative

Sender's comments: the adverse event of vomiting was classified as serious due to hospitalization of a 67-year-old female patient 5 days after mapping procedure and on the day the implant procedure was conducted.No chemotherapy had been administered yet.Vomiting is expected for sir-spheres microspheres and implant procedure and unexpected for mapping procedure.The temporal relationship is implausible for the mapping procedure but plausible for implant procedure and sir-spheres microspheres.Already during the implant procedure, the patient started feeling nauseous and subsequently vomited.Although vomiting is a common side effect of the patient's concomitant medication including carvedilol, the temporal course is indicative for a causal role of implant procedures and sir-spheres microspheres.Therefore, the sponsor concurs with the investigator and assesses the event of vomiting as probably related to implant procedure and sir-spheres microspheres and as not related to mapping procedure.With follow-up information received on 29-jul-2019 the serious event pain was added.Pain is unexpected for sir-spheres microspheres and related procedures but of note abdominal pain, to which pain likely refers considering the information provided in the initial report, is expected for sir-spheres microspheres and implant procedures.The temporal relationship is plausible for sir-spheres microspheres and implant procedure and implausible for the mapping procedure.Occurrence of abdominal pain after the implantation procedure is well known and initially it was reported that the patient suffered from vomiting and abdominal pain, thus it is likely that pain occurred in this context.The investigator did not provide a causality assessment for the newly added event of pain.Considering the information provided overall, the sponsor assesses pain as possibly related to implant procedure and sir-spheres microspheres and as not related to mapping procedure.Therefore, the sponsor concurs with the investigator and assesses the event of vomiting as probably related to implant procedure and sir-spheres microspheres and as not related to mapping procedure.With follow-up information received on 06-aug-2019 it was clarified that pain refers to abdominal pain, thus the event term was amended accordingly.Abdominal pain is expected for sir-spheres microspheres and implant procedure and unexpected for mapping procedure.The temporal relationship is implausible for the mapping procedure but plausible for implant procedure and sir-spheres microspheres.The investigator assessed the event as not related to mapping procedure and not related to sir-spheres microspheres and as possibly related to implant procedure.Considering the temporal course and known safety profile, the sponsor assesses the event of abdominal pain as not related to mapping procedure and as possibly related to implant procedure and sir-spheres microspheres.

Event Description

A serious adverse event report, (case number (b)(4)), was received from an investigator in spain regarding a female 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 02-jul-2019.The reported event term was vomiting.At the time of the event onset the patient was 67-year-old.The patient's medical history was significant for unresectable intrahepatic cholangiocarcinoma and ischemic heart disease in 2006.Concomitant medication included adiro (acetylsalicylic acid) tablets, 100 mg daily, since 2006, for ischemic heart disease; coropres (carvedilol) tablets, 6.25 mg daily, since 2006, for ischemic heart disease; and trankimazin (alprazolam) tablets, 0.25 mg daily , since unknown date, for anxiety, 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 (1.24 gbq, batch no.Nf45v10) was performed on (b)(6) 2019 via intrahepatic artery.At the time of the event treatment with chemotherapy agents (cisplatin-gemcitabine) was not yet started.On (b)(6) 2019, the patient presented with vomiting and was hospitalized.During sir-spheres microspheres implantation the patient started with nausea and pain.Once the treatment had been finished, she was moved to the observation ward.The patient continued with pain (abdominal) and vomiting.Ondansetron and paracetamol were given but around 7 pm the patient was still feeling discomfort and pain.It was decided that the patient was hospitalized.On the next morning she was feeling better although still having had 2 episodes of vomiting.The event was of moderate severity.At the time of the report, the patient was recovering.Follow-up information was received on 29-jul-2019: the event of vomiting stopped on (b)(6) 2019.The investigator confirmed that pain was considered as additional sae.No further information was provided.Follow-up information was received on 06-aug-2019: the investigator clarified that pain referred to abdominal pain (moderate).Abdominal pain started on (b)(6) 2019 and stopped on (b)(6) 2019, the outcome was recovered.Reporter's comments: the investigator assessed the event as not related to sir-spheres microspheres (mapping procedure) and as probably/likely related to sir-spheres microspheres (implant procedure) and sir-spheres microspheres (medical device).Follow-up information received on 29-jul-2019: the investigator did not provide a causality assessment for the event of pain.Follow-up information received on 06-aug-2019.The investigator assessed the event of abdominal pain as not related to sir-spheres microspheres mapping procedure, as possibly related to sir-spheres microspheres implant procedure and as not related to sir-spheres microspheres medical device.

• 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 Key: 8775309
• MDR Text Key: 150554882
• Report Number: 3005579300-2019-00006
• Device Sequence Number: 1
• Product Code: NAW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Type of Report: Initial,Followup,Followup
• Report Date: 08/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: NF45V10
• Initial Date Manufacturer Received: 07/02/2019
• Initial Date FDA Received: 07/10/2019
• Supplement Dates Manufacturer Received: 07/29/2019; 08/06/2019
• Supplement Dates FDA Received: 08/06/2019; 08/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACETYLSALICYCLIC ACID.; ACETYLSALICYCLIC ACID.; ACETYLSALICYCLIC ACID.; ALPRAZOLAM.; ALPRAZOLAM.; ALPRAZOLAM.; CARVEDILOL.; CARVEDILOL.; CARVEDILOL.; ACETYLSALICYCLIC ACID; ALPRAZOLAM; CARVEDILOL
• Patient Outcome(s): Hospitalization
• Patient Age: 67 YR
• Patient Weight: 87