MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-10 for SIR-SPHERES? Y-90 RESIN MICROSPHERES manufactured by Sirtex Technology Pty Ltd / Sirtex Medical Limited.
[144942699]
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 nearly 4 weeks 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 12 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. The investigator assessed the event as not related although the relatedness in regard to the single imps/ procedures was not specified. Considering the available information and the alternative explanation, the sponsor assesses the event as not related to nivolumab, mapping and implant procedures and as unlikely related to sir-spheres microspheres. With follow-up information received on 28-apr-2019 the event term was amended to anal abscess. The event is unexpected for sir-spheres, microspheres, mapping and implant procedures as well as nivolumab. The temporal relationship is plausible for nivolumab and sir-spheres microspheres and implausible for the procedures. Development of an anal abscess can be promoted by various factors, such as anal fissures, inflammatory bowel diseases, diarrhoea, constipation and a compromised immune system. In addition, anal abscess is among the most common diseases encountered in adults and men are affected twice as often as women (abcarian 2011). The investigator assessed the event as possibly related to sir-spheres microspheres and did not provide a causality assessment for nivolumab and mapping and implant procedures. Based on the limited information available and in absence of any information supporting a causal role of sir-spheres microspheres, the sponsor assessed the event of anal abscess as not related to sir-spheres microspheres, related procedures and nivolumab.
Patient Sequence No: 1, Text Type: N, H10
[144942700]
This case became reportable with follow-up information received on 28-apr-2019: a serious adverse event report, (case number (b)(4)), was received from an investigator in spain regarding a male patient (patient no. 01010) enrolled in "(b)(6)", study code (b)(6). Initial report was received on (b)(6) 2019. The reported event term was "liver decompensation". At the time of the event onset the patient was (b)(6). 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. Nivolumab therapy was started on (b)(6) 2019, the last administration prior to event onset was on (b)(6) 2019. Study participation of the patient was terminated on (b)(6) 2019 due to disease progression. The patient was evaluated for diarrhea and sphincter pain. He presented with jaundice, choluria, acholia, and ascites. He showed analytical deterioration. On (b)(6) 2019 the patient was hospitalized for symptomatic treatment of liver decompensation. The event was of moderate severity. Relevant laboratory tests revealed bilirubin elevation, hypoalbuminemia, hypertransaminasemia, and high level of c-reactive protein (for further information please refer to structured information). The patient was treated with nolotil (metamizole magnesium), 2 g, i. V. , as needed, tramadol, 50 mg, i. V. , as needed, and paracetamol, 1 g, i. V. , as needed all started on (b)(6) 2019 and ongoing. At the time of the report, the outcome was unknown. Follow-up information was received on 28-apr-2019: the event term was changes to "anal abscess". Implanted activity of sir-spheres microspheres was 1. 4 gbq, sublobar. Last administration of nivolumab prior to the event was provided as (b)(6) 2019. On (b)(6) 2019, an anal endoscopy was performed diagnosing anal abscess. On (b)(6) 2019, an anal examination was performed in the operating room to drain the abscess, no complications were observed. The patient received antibiotic and analgesic treatment and was discharged on (b)(6) 2019. Details on antibiotic treatment included metronidazole 500 mg oral, every 8 hours, start date (b)(6) 2019 and augmentin (amoxicillin/ clavulanic acid) 875 mg oral, every 8 hours, start date (b)(6) 2019, both ongoing. The event resolved without sequelae. Reporter's comment: the investigator assessed the event as not related but did not specify the relatedness in regards to sir-spheres microspheres (mapping procedure, implant procedure, and medical device) and nivolumab. With follow-up information received on 28-apr-2019, the investigator assessed the event of anal abscess as possibly related sir-spheres microspheres (medical device) and did not provide the relationship for the mapping and implant procedure as well as nivolumab.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005579300-2019-00003 |
| MDR Report Key | 8598454 |
| Date Received | 2019-05-10 |
| Date of Report | 2019-05-22 |
| Date of Event | 2019-04-15 |
| Date Mfgr Received | 2019-05-14 |
| 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 | 0 |
| 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 |