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 2019-04-05 for THERASPHERE UNKNOWN N/A manufactured by Biocompatibles Uk Ltd.
[141062164]
The events were reported through a retrospective clinical trial. The events are considered serious and probably related to the therasphere administration. Btg medical assessment: subject (b)(6) is a (b)(6) asian female. Hcc diagnosis date: (b)(6) 2016, no presence of portal hypertension, no cirrhosis, (b)(6), no prior sorefenib treatment before therasphere; no disease specific surgery, baseline bclc stage: c, at baseline platelet count 116 ku/l, wbc 3. 5 ku/l, albumine 34g/l, ast 4xuln, normal bilirubin, afp 1638, tumor involvement in the right lobe (85mm) with portal vein thrombosis grade 3. Treated with therasphere (b)(6) 2017. Activity recorded at start of treatment: 2. 24gbq; lung shunt fraction 4%. Follow-up visit (b)(6) 2017: platelet count 102 ku/l, wbc 3. 7ku/l, albumine 29g/l, ast 4xuln, normal bilirubin, afp 449. Follow-up visit (b)(6) 2017: platelet count 279 ku/l, wbc 7. 8 ku/l, albumine 21g/l, ast 3xuln, bilirubin 19 mg/l, afp 25. On (b)(6) 2017 the patient experienced ascites and limb edema and was admitted to the hospital. Action taken: paracentesis spironolactone furosemide. Patient outcome: recovered/resolved (b)(6) 2017. On (b)(6) 2017 the patient experienced ascites and bilirubin increase and was hospitalized. Action taken for ascites: paracentesis. Patient outcome: recovered/resolved (b)(6) 2017, action taken for elevated bilirubin: not provided, lead to death. The above events were not reported to btg by the investigator in 2017. Blood bilirubin increased; limb edema; acites; death - anticipated adverse events listed in the ifu/risk management documentation. Blood bilirubin increased - possibly related to therasphere and patient pre-existing condition. Serious. Ascites - possibly related to therasphere and patient pre-existing condition. Serious limb edema - possibly related to therasphere and patient pre-existing condition. Serious death- possibly related to therasphere and patient pre-existing condition. Serious 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
[141062165]
The events were reported through a retrospective clinical trial. Subject (b)(6) is a (b)(6) asian female enrolled on the (b)(6) study hcc diagnosis date: (b)(6) 2016, no presence of portal hypertension, no cirrhosis, (b)(6), no prior sorefenib treatment before therasphere; no disease specific surgery, baseline bclc stage: c, at baseline platelet count 116 ku/l, wbc 3. 5 ku/l, albumine 34g/l, ast 4xuln, normal bilirubin, afp 1638, tumor involvement in the right lobe (85mm) with portal vein thrombosis grade 3. Treated with therasphere (b)(6) 2017. Activity recorded at start of treatment: 2. 24gbq; lung shunt fraction 4%. Follow-up visit (b)(6) 2017: platelet count 102 ku/l, wbc 3. 7ku/l, albumine 29g/l, ast 4xuln, normal bilirubin, afp 449, follow-up visit (b)(6) 2017: platelet count 279 ku/l, wbc 7. 8 ku/l, albumine 21g/l, ast 3xuln, bilirubin 19 mg/l, afp 25. Patient died (b)(6) 2017. On (b)(6) 2017 the patient experienced ascites and was hospitalized. Action taken: paracentesis spironolactone furosemide. Patient outcome: recovered/resolved (b)(6) 2017. On (b)(6) 2017 the patient also experienced limb edema and was hospitalized. Action taken: furosemide spironolactone. Patient outcome: recovered/resolved (b)(6) 2017. On (b)(6) 2017 the patient experienced ascites and was hospitalized. Action taken: paracentesis. Patient outcome: recovered/resolved (b)(6) 2017. The above events were not reported to btg by the investigator in 2017.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002124543-2019-00030 |
| MDR Report Key | 8487476 |
| Report Source | HEALTH PROFESSIONAL,STUDY |
| Date Received | 2019-04-05 |
| Date of Report | 2019-04-03 |
| Date of Event | 2017-07-30 |
| Date Mfgr Received | 2019-04-03 |
| Date Added to Maude | 2019-04-05 |
| 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 | 2019-04-05 |
| 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. Death; 2. Hospitalization; 3. Required No Informationntervention | 2019-04-05 |