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 2019-05-09 for THERASPHERE UNKNOWN N/A manufactured by Biocompatibles Uk Ltd.
[144560071]
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: subject (b)(6) is a (b)(6) male patient. Diagnosed with hcc on an unknown date in (b)(6) 2017. Etiologic associations: liver cirrhosis related to alcohol abuse. Ongoing (b)(6) and diabetes. No prior sorafenib treatment or disease specific surgery prior to therasphere? Treatment. Baseline bclc: stage c. Biochemistry and tumour marker - bilirubin 0. 70, albumine 41g/l, afp 75ng/ml, ggt 260ui/l. Hcc in the right liver lobe, 120mm largest diameter, one tumor. Therasphere? Treatment: (b)(6) 2017. Activity at start of infusion: 5. 56gbq. Residual in delivery set 0. 013gbq. Lung shunt fraction 3. 2%. Target lesion: right liver lobe, treated volume 79% of total liver volume. Dose to the perfused liver: 125gy. Dose to whole liver: 90gy. Concomitant medications: pantoprazole 20 mg ((b)(6) 2017). Tramadol 100mg/ml ((b)(6) 2017). Paracetamol 1000 mg ((b)(6) 2017). The patient developed ascites (grade 1) (b)(6) 2017; aspartate aminotransferase increased (grade 3) (b)(6) 2017; 206ui/l, bilirubin creased (grade 3) (b)(6) 2017; 3. 3 mg/l, gamma glutamyl transferase increased (grade 3) (b)(6) 2017 - 495ui/l. All non-serious events. On (b)(6) 2017 the patient experienced hepatic failure (grade 4) resulting in death (grade 5 ). The reporter assessed the event of hepatic failure as related to therasphere treatment. Conclusion: hepatic failure, related to therasphere? Administration in a patient with a huge tumor dose to the tumor was within the recommended dose so that an "overdosing" could not be responsible of the event. Serious adverse events, anticipated events associated with therasphere procedure listed in the risk management documentation. 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. At this time this report is considered final.
Patient Sequence No: 1, Text Type: N, H10
[144560072]
Auto-notification received from (b)(4) 08-may-2019. Subject (b)(6) is a (b)(6) male patient enrolled on the (b)(6) study. Diagnosed with hcc on an unknown date in (b)(6) 2017. Etiologic associations: liver cirrhosis related to alcohol abuse. Ongoing (b)(6) and diabetes. No prior sorafenib treatment or disease specific surgery prior to therasphere? Treatment. Baseline bclc: stage c. Biochemistry and tumour marker - bilirubin 0. 70, albumine 41g/l, afp 75ng/ml, ggt 260ui/l. Hcc in the right liver lobe, 120mm largest diameter, one tumor. Therasphere? Treatment: (b)(6) 2017. Activity at start of infusion: 5. 56gbq. Residual in delivery set 0. 013gbq. Lung shunt fraction 3. 2%. Target lesion: right liver lobe, treated volume 79% of total liver volume. Dose to the perfused liver: 125gy. Dose to whole liver: 90gy. Concomitant medications: pantoprazole 20 mg ((b)(6) 2017). Tramadol 100mg/ml ((b)(6) 2017). Paracetamol 1000 mg ((b)(6) 2017). The patient developed ascites (grade 1) (b)(6) 2017; aspartate aminotransferase increased (grade 3) (b)(6) 2017; 206ui/l, bilirubin creased (grade 3) (b)(6) 2017; 3. 3 mg/l, gamma glutamyl transferase increased (grade 3) (b)(6) 2017 - 495ui/l. All non-serious events. On (b)(6) 2017 the patient experienced hepatic failure (grade 4) resulting in death (grade 5). The reporter assessed the event of hepatic failure as related to therasphere treatment. The events were not reported to btg by the investigator in 2017.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002124543-2019-00039 |
| MDR Report Key | 8594948 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,S |
| Date Received | 2019-05-09 |
| Date of Report | 2019-05-08 |
| Date of Event | 2017-09-21 |
| Date Mfgr Received | 2019-05-08 |
| Date Added to Maude | 2019-05-09 |
| 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, 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 | 2019-05-09 |
| 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, GU9 8QL UK GU9 8QL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2019-05-09 |