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Lot Number NI403V09
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Encephalopathy (1833); Confusion/ Disorientation (2553)
Event Date 01/30/2020
Event Type  Death  
Manufacturer Narrative
The adverse events of radiation-induced liver disease (reild) and encephalopathy were classified as serious since the (b)(6)-year old male patient was hospitalized about 2 months after start of the 3rd chemotherapy cycle and nearly 5 months after implantation of sir-spheres microspheres. Reild is expected for sir-spheres microspheres and unexpected for related procedures and chemotherapy. Encephalopathy is unexpected for sir-spheres microspheres (only hepatic encephalopathy expected), related procedures and chemotherapy. The temporal relationship is implausible regarding the procedures and plausible for chemotherapy and sir-spheres microspheres considering latency effects and the previous hospitalization. Usually reild occurs 4-8 weeks after sirt and of note, general status deterioration, which was later considered to be caused by reild, led to hospitalization about 2 months after implantation procedure (see linked case (b)(4)). The concurrently reported cognitive impairment may have been an early symptom of the event encephalopathy, however according to the linked case the event had resolved about 3 weeks after onset and therefore it remains unclear whether this was a symptom or an independent episode. The test results provided were consistent with what is typically seen in reild since the patient showed elevation of bilirubin above 3mg/dl as well as increased alp, increased ggt and hepatic ultrasound did not show biliary duct expansion. Of note, no further information on clinical picture and details on further diagnostic work-up were available. An eeg revealed that the patient suffered from metabolic encephalopathy. The patient's advanced age is associated with an increased risk and hepatic insufficiency and imbalances such as hyperglycaemia have been associated with the development of the metabolic encephalopathy (berisavac et al. , 2017). Of note, metabolic encephalopathy is unexpected for sir-spheres microspheres, whereas hepatic encephalopathy is expected and may be the more specific diagnosis here, although this was not confirmed and no further details were available. The investigator assessed the events as probably related to sir-spheres microspheres, unlikely related to procedures and not related to chemotherapy. Based on the information available and as the encephalopathy occurred concurrently with reild, the sponsor concurs and assesses the events as related to sir-spheres microspheres and not related to procedures and chemotherapy.
Event Description
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), study code (b)(4). Initial report was received on 31-jan-2020: the reported event terms were radioembolization induced liver disease (reild) and encephalopathy. At the time of the event onset the patient was (b)(6)-year-old. This case is linked to case number (b)(4) (sae terms: general physical health deterioration and cognitive disorder). The patient's medical history was significant for unresectable intrahepatic cholangiocarcinoma, cardiac arrhythmia, diagnosed on (b)(6) 2004, and high blood pressure, all ongoing, as well as ascites, status unknown. Concomitant medication included methylprednisolone tablets, 20 mg per day, orally, from (b)(6) 2020 for reild, aldactone tablets (spironolactone), 50 mg per day, orally, since (b)(6) 2020 for ascites, lasilix tablets (furosemide), at an unknown dose, orally, from (b)(6) 2020 for ascites and delursan tablets (ursodeoxycholic acid), 250 mg per day, orally, since (b)(6) 2020 for reild. 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 events occurred during chemotherapy cycle 03 started on (b)(6) 2019. The second administration was not yet performed. On (b)(6) 2020, the patient was hospitalized due to an important general status deterioration (oms4) and worsening confusion without waking up and loss of autonomy. The event of reild was life-threatening, the encephalopathy was severe. A hepatic ultrasound was done but did not show a biliary duct expansion. An eeg was performed, revealing a metabolic encephalopathy. Further relevant laboratory/diagnostic tests included total bilirubin
63 um (reference range: 1-17 um), ggt
848 ui/l (reference range: 8-61 ui/l), apl
298 ui/l (reference range: 40-130 ui/l) and glycemia
3. 8 g/l (reference range: 0. 65-1. 15 g/l). The patient was treated with an increase of methylprednisolone to 1 mg/kg/day. At the time of the report, the events were ongoing. Reporter's comments: the investigator assessed the events as unlikely related to the sir-spheres microspheres mapping and implant procedure, as probably related to sir-spheres microspheres (medical device) and as not related to cisplatin and gemcitabine.
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Manufacturer (Section D)
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Manufacturer Contact
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MDR Report Key9738549
MDR Text Key193030320
Report Number3005579300-2020-00002
Device Sequence Number1
Product Code NAW
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,s
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/21/2020
Is this an Adverse Event Report? Yes
Device Operator
Device Lot NumberNI403V09
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/09/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 02/21/2020 Patient Sequence Number: 1