MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,s report with the FDA on 2019-05-10 for SIR-SPHERES? Y-90 RESIN MICROSPHERES manufactured by Sirtex Technology Pty Ltd / Sirtex Medical Limited.
[144672960]
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.
Patient Sequence No: 1, Text Type: N, H10
[144672961]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005579300-2019-00002 |
| MDR Report Key | 8598436 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,S |
| Date Received | 2019-05-10 |
| Date of Report | 2019-05-22 |
| Date of Event | 2019-04-23 |
| Date Mfgr Received | 2019-05-08 |
| Date Added to Maude | 2019-05-10 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | SHOP 6 207 PACIFIC HIGHWAY |
| Manufacturer City | ST LEONARDS, 2065 |
| Manufacturer Country | AS |
| Manufacturer Postal | 2065 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SIR-SPHERES? Y-90 RESIN MICROSPHERES |
| Generic Name | MICROSPHERES |
| Product Code | NAW |
| Date Received | 2019-05-10 |
| Lot Number | NA405V12 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIRTEX TECHNOLOGY PTY LTD / SIRTEX MEDICAL LIMITED |
| Manufacturer Address | SHOP 6 207 PACIFIC HIGHWAY ST LEONARDS, 2065 AS 2065 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2019-05-10 |