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 2019-05-10 for THERASPHERE UNKNOWN N/A manufactured by Biocompatibles Uk Ltd.
[144675582]
The events were reported through a retrospective clinical trial. The events are considered serious due to hospitalization and related to therasphere administration. Btg medical assessment: subject: (b)(6) is a (b)(6) year old male patient enrolled in the (b)(6) study. Diagnosed with hcc (b)(6) 2011. Presence of portal hypertension (b)(6) 2011. Aetioligic associations: liver cirrhosis; non alcoholic steatohepatitits. No prior sorafenib treatment. Baseline bclc stage: c. No disease specific surgery. Presence of portal main branch thrombosis, no ascites at baseline and low platelet count. Bilobar disease. Treated with therasphere (b)(6) 2011. Activity recorded at start of infusion: gbq 5. 03. Residuals remaining in delivery set: gbq 0. 48. Total administered: gbq 4. 55. Lung shunt fraction 15. 7%. Therasphere administered in the right hepatic artery. Patient experienced: ascites and edema limbs on an unknown date in (b)(6) 2011. Treatment received furosemide and spironolactone. Ascites and edema limbs requiring hospitalization: serious adverse events, severity 3, causality - related to therasphere, anticipated adverse events listed in the ifu/risk management documentation. No device malfunction was reported and no corrective and preventive action (capa) plan has been indentified. 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
[144675583]
Auto-notification received from (b)(4) 08-may-2019. Subject: (b)(6) is a (b)(6) year old male patient enrolled in the (b)(6) study. Diagnosed with hcc (b)(6) 2011. Presence of portal hypertension (b)(6) 2011. Aetioligic associations: liver cirrhosis; non alcoholic steatohepatitits. No prior sorafenib treatment. Baseline bclc stage: c. No disease specific surgery. Presence of portal main branch thrombosis, no ascites at baseline and low platelet count. Bilobar disease. Treated with therasphere (b)(6) 2011. Activity recorded at start of infusion: gbq 5. 03. Residuals remaining in delivery set: gbq 0. 48. Total administered: gbq 4. 55. Lung shunt fraction 15. 7%. Patient experienced: ascites and edema limbs on an unknown date in (b)(6) 2011. Treatment received furosemide spirnolactone. Additional information received 08-may-2019. The patient was hospitalized. The events were not reported to btg by the investigator in 2011.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002124543-2019-00042 |
| MDR Report Key | 8598829 |
| Report Source | HEALTH PROFESSIONAL,STUDY |
| Date Received | 2019-05-10 |
| Date of Report | 2019-06-02 |
| Date of Event | 2011-12-15 |
| Date Mfgr Received | 2019-06-02 |
| 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 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 | 2019-05-10 |
| Model Number | UNKNOWN |
| Catalog Number | N/A |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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. Hospitalization | 2019-05-10 |