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 2019-05-24 for THERASPHERE UNKNOWN N/A manufactured by Biocompatibles Uk Ltd.
[146073045]
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) male patient enrolled on the (b)(6) study. Diagnosed with hcc on an unknown date. Presence of portal hypertension with oesophagus varices and pancytopenia at the blood test. Etiologic associations: liver cirrhosis; (b)(6); previous alcohol addiction; no prior sorafenib treatment before therasphere treatment; bclc stage: c; no disease specific surgery. Unknown date patient received therasphere treatment (around (b)(6) 2016). Cp at base line at least (b)(6), the patient had 3 points on albumin. No concomitant disease. On (b)(6) 2016 the patient experienced: edema; reduced general condition; ascites; albumin decreased; bilirubin increased; creatinine increased; liver decompensation. Reild events: edema; ascites; albumin deceased; bilirubin increased; liver decompensation: serious adverse events, related to therasphere. Expected reduced general condition: serious adverse event, related to therasphere. Expected creatinine increased: non-serious adverse event, not related to therasphere. Expected. All events are anticipated adverse events listed in the risk management documentation/ifu. Therasphere is contra-indicated for patients with severe liver dysfunction and physicians should consider when selecting patients (patient was child (b)(6) at entry). 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. Additional information has also been sought regarding the treatment date and hospital admission and discharge dates 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
[146073046]
Auto-notification received from datatrak 17-may-2019. Subject (b)(6) is a (b)(6) male patient enrolled on the (b)(6) study. Diagnosed with hcc on an unknown date. Presence of portal hypertension with oesophagus varices and pancytopenia at the blood test. Etiologic associations: liver cirrhosis; (b)(6); previous alcohol addiction; no prior sorafenib treatment before therasphere treatment; bclc stage: c; no disease specific surgery. Unknown date patient received therasphere treatment (around (b)(6) 2016). Cp at base line at least (b)(6), the patient had 3 points on albumin. No concomitant disease. On (b)(6) 2016 the patient experienced: edema; reduced general condition; ascites; albumin decreased; bilirubin increased; creatinine increased; liver decompensation. The events were not reported to btg by the investigator in 2016.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002124543-2019-00045 |
| MDR Report Key | 8639403 |
| Report Source | HEALTH PROFESSIONAL,STUDY |
| Date Received | 2019-05-24 |
| Date of Report | 2019-05-17 |
| Date of Event | 2016-10-12 |
| Date Mfgr Received | 2019-05-17 |
| Date Added to Maude | 2019-05-24 |
| 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 | 2019-05-24 |
| 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. Hospitalization | 2019-05-24 |