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Serious adverse events of liver pain and pleuritic pain led to hospitalization of a (b)(6 ) year-old female patient 6 days after implantation of sir-spheres microspheres and 13 days after sir-spheres mapping procedure.
The temporal relationship is plausible for sir-spheres microspheres and implantation procedure, but implausible for mapping procedure for both events.
Liver pain and pleuritic pain are expected for sir-spheres microspheres (in terms of abdominal pain which can radiate to chest, groin and back) and implantation procedure (in terms of pain) but unexpected for the mapping procedure.
Liver pain and pleuritic pain (verbatim: liver capsule or pleuritic pain) might be caused by the patient's underlying intrahepatic cholangiocarcinoma, which is known for a high degree of malignancy.
Furthermore, abdominal pain is a known side effect of the patient's concomitant medication including oxycodone hydrochloride, fentanyl and omeprazole.
Oxycodone is known to induce pain in general (e.
G.
Chest pain).
However, sir-spheres microspheres and implantation procedure, both, might also have contributed to liver pain and pleuritic pain as a consequence of tissue injury and irritation.
The investigator assessed the events as unrelated to sir-spheres microspheres and mapping procedure and as probably related to implantation procedure.
In view of the known safety profile and temporal relationship the sponsor assesses the events as possibly related to sir-spheres microspheres and implantation procedure and as unrelated to mapping procedure.
With follow-up information received on 12-jul-2017, pleuritic pain was deleted as adverse event.
The causality assessment for the event liver pain remains unchanged.
By follow-up information received on 14-aug-2017 the investigator's causality assessment was reported as probably/likely for sir-spheres microspheres, not related for sir-spheres microspheres mapping procedure and unlikely for sir-spheres microspheres implant procedure.
The causality assessment remains unchanged.
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This report combines information received between 25-may-2017 and 14-aug-2017.
This is the initial medical device report submitted to the fda.
A serious adverse event report was received on 25-may-2017 from an investigator in australia regarding a (b)(6) year-old female patient (patient no.
(b)(6)) enrolled in "a (b)(6) 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)(6).
The reported event term was liver capsule or pleuritic pain.
The patient received combined modality treatment sir-spheres microspheres + cis-gem chemotherapy.
Sir-spheres mapping procedure took place on (b)(6) 2017, implant procedure took place on (b)(6) 2017.
The patient received a total dose of 2.
03 gbq (batch number le209v13) via the right common femoral artery.
Treatment with chemotherapy agents (cisplatin-gemcitabine) was not started yet at the time of the event.
The patient's medical history included intrahepatic cholangiocarcinoma, right mastectomy, and hypotension.
Concomitant medication included: prochlorperazine, 5 mg, prn, oral, since (b)(6) 2017 ongoing for nausea.
Oxycodone hydrochloride/naloxone hydrochloride, 5-10 mg, twice daily, oral, since (b)(6)2017 ongoing for pain.
Fentanyl, 100 mg, prn, sublingual, since (b)(6) 2017 ongoing for pain.
Omeprazole, 20 mg, daily, oral, since unknown date, ongoing.
On (b)(6) 2017, the patient developed liver capsule or pleuritic pain.
On (b)(6) 2017, the patient was hospitalized for right base neck/shoulder pain (positional and pleuritic).
She had no shortness of breath, cough or pulmonary embolism.
The patient had an episode of hypotension and was reviewed by cmo.
The event was treated with tramadol hydrochloride (oral) 100 mg four times a day on (b)(6) 2017 and ibuprofen (oral) 400 mg three times a day from (b)(6) 2017.
The patient was not withdrawn from the study due to this event.
The patient was discharged from hospital on (b)(6) 2017.
Follow-up information was received on 12-jul-2017: the event term was changed from "liver capsule or pleuritic pain" to "liver capsular pain".
The investigator considered the event as serious with hospitalization on (b)(6) 2017.
No complications during the implantation procedure were reported.
The intrahepatic application site of sir-spheres microspheres was specified as bilobal.
Follow-up information was received on 14-aug-2017: the investigator considered the event as an effect of radiation and possible vaso-spasm.
Reporter's comments: the investigator assessed the events as not related to sir-spheres microspheres (medical device), as not related to the sir-spheres microspheres (mapping procedure), and as probably related to the sir-spheres microspheres (implant procedure).
Follow up information received on 12-jul-2017.
The investigator reported the event as "due to spheres".
Follow up will be requested regarding the contradictory information provided.
With follow up information received on 14-aug-2017 the causality assessment was confirmed as "probably/likely" for sir-spheres microspheres (device), as "not related" for sir-spheres microspheres (mapping procedure) and as "unlikely" for sir-spheres microspheres (implant procedure).
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