MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,study report with the FDA on 2019-04-15 for THERASPHERE UNKNOWN N/A manufactured by Biocompatibles Uk Ltd.
[141924634]
The events were reported through a retrospective clinical trial. The events are considered serious and related to therasphere administration and possibly to patient disease progression. Btg medical assessment: male (b)(6), hcc diagnosed the (b)(6) 2016 with a biopsy, one nodule in segment vii, afp 7661. 1 ng/ml, child a5, bclc c (ecog 1), therasphere? Administration the (b)(6) 2016, 3 vials administered, lobar administration, total activity administered= uk, lung shunt 16. 5%, second therasphere treatment administered for progression on the (b)(6) 2018, 2 vials, selective administration, location of administration unk, total activity administered= uk, lung shunt 7%. Patient developed upper abdominal pain after procedure (b)(6) 2018 and went to local ed (b)(6) 2018 and was admitted at the hospital (b)(6) 2018 and given oral pain medication and discharged. The patient was explored with ct scan of abdomen ((b)(6)) and angio ct for chest ((b)(6)), that does not show, any abdominal and pleural effusion, no gastric disease, no pancreas disease. Only images related to disease progression to lungs and progression of cirrhosis (splenomegaly, and esophagus varices). After discharge (b)(6) 2019 dull pain persisted and received celiac plexus block and followed by pain specialist who prescribed long acting pain medication. Due to progression of the disease out of the liver, the patient started another anticancer treatment (immunotherapy) no device malfunction was reported and no corrective and preventive action (capa) plan has been identified. The lot number associated with the therasphere administration was not reported, therefore no investigation could be performed. If additional information becomes available, a follow up report will be submitted. No other information is available that could confirm/deny the alleged event. Abdominal pain is an anticipated adverse event as per the ifu/risk management documentation. At this time this report is considered final.
Patient Sequence No: 1, Text Type: N, H10
[141924635]
Subject (b)(6) is a (b)(6) male patient enrolled in the (b)(6) study. This patient was diagnosed with hcc on (b)(6) 2016. Liver status: liver cirrhosis, hcc etiology: (b)(6), solitary lesion at: vii, bclc classification: bclc c (ecog 1), therasphere was administered on (b)(6) 2016 and the patient was discharged within 24 hours. 3 vials administered, lobar administration, total activity administered= uk, lung shunt 16. 5%. Second therasphere treatment administered for progression on the (b)(6) 2018, 2 vials, selective administration, location of administration unk, total activity administered= uk, lung shunt 7%. On an unknown date in (b)(6) 2018 - following 2nd treatment on (b)(6) 2018: patient developed upper abdominal pain after procedure (b)(6) 2018 and went to local ed (b)(6) 2018 and was admitted at the hospital (b)(6) 2018 and given oral pain medication and discharged. The patient was explored with ct scan of abdomen ((b)(6)) and angio ct for chest ((b)(6)), that does not show, any abdominal and pleural effusion, no gastric disease, no pancreas disease. Only images related to disease progression to lungs and progression of cirrhosis (splenomegaly, and esophagus varices). After discharge (b)(6) 2019 dull pain persisted and received celiac plexus block and followed by pain specialist who prescribed long acting pain medication. Due to progression of the disease out of the liver, the patient start another anticancer treatment (immunotherapy). The events were not reported to btg by the investigator in 2018.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002124543-2019-00034 |
| MDR Report Key | 8513365 |
| Report Source | HEALTH PROFESSIONAL,STUDY |
| Date Received | 2019-04-15 |
| Date of Report | 2019-03-21 |
| Date of Event | 2018-03-08 |
| Date Mfgr Received | 2019-03-21 |
| Date Added to Maude | 2019-04-15 |
| 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 Contact | MS SANDRA BAUSBACK-ABALLO |
| Manufacturer Street | 300 FOUR FALLS CORPORATE CENTE 300 CONSHOHOCKEN STATE ROAD |
| Manufacturer City | WEST CONSHOHOCKEN, PA 194282998 |
| Manufacturer Country | US |
| Manufacturer Postal | 194282998 |
| Manufacturer Phone | 6103311537 |
| Manufacturer G1 | BIOCOMPATIBLES UK |
| Manufacturer Street | CHAPMAN HOUSE WEYDON LANE |
| Manufacturer City | FARNHAM, SURREY GU9 8QL |
| Manufacturer Country | UK |
| Manufacturer Postal Code | GU9 8QL |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THERASPHERE |
| Generic Name | YTTRIUM-90 GLASS MICROSPHERES, PRODUCT CODE: NAW |
| Product Code | NAW |
| Date Received | 2019-04-15 |
| Model Number | UNKNOWN |
| Catalog Number | N/A |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOCOMPATIBLES UK LTD |
| Manufacturer Address | CHAPMAN HOUSE FARNHAM BUS PARK WEYDON LANE FARNHAM, SURREY GU9 8QL UK GU9 8QL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2019-04-15 |