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 2020-03-10 for THERASPHERE 5.14 GBQ N/A manufactured by Biocompatibles Uk Ltd.
[182801887]
Btg medical assessment: patient received a treatment with therasphere? , quite a high activity to the right liver, in a patient for whom, at baseline, there was a warning regarding the administration of therasphere? , (bilirubin >34 micromol/l), therefore this patient was at high risk of complication. Due to the poor baseline liver function the treatment lead to deterioration of the pre-existing altered liver function with the occurrence within one month after treatment of ascites, encephalopathy, asthenia, degradation of ecog status, elevation of bilirubin, albumin decrease, weight loss, fatigue, elevation of creatinine, decrease of coagulation test. In conclusion: liver function degradation leading to death due to therasphere? Administration and disease progression in a patient with pre-existing altered liver function. Ascites: severity 4; serious; related device; anticipated deterioration of ecog status: severity 2; non-serious; related device; anticipated weight loss/anorexia: severity unknown; non-serious; related device; anticipated liver function deterioration: severity 4; serious; related device and disease progression; anticipated. Confusion: severity unknown; non-serious; related to liver function deterioration; anticipated. Blood bilirubin increase: severity 2 (basline abnormal); non-serious; related to liver function deterioration; anticipated. Hypoalbuminemia: severity 2; non-serious; related to liver function deterioration; anticipated. Asthenia/fatigue: severity 3; non-serious; related to liver function deterioration; anticipated. Alt increase: severity 2; non-serious; related to liver function deterioration; anticipated ast increase: severity 3; non-serious; related to liver function deterioration; anticipated deterioration of coagulation test: severity 3; non-serious; related to liver function deterioration; anticipated. Diarrhoea: severity unknown; non-serious; related to liver function deterioration; anticipated. Coagulation test deterioration: severity 4; non-serious; related to liver function deterioration; anticipated creatinine increase: severity 2; non-serious; related to liver function deterioration; anticipated. Encephalopathy: severity 4; serious; related to liver function deterioration; anticipated death: severity 5; serious; related to liver function deterioration; anticipated. 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
[182801888]
Auto-notification received from datatrak 13-feb-2020 for a patient enrolled on the (b)(6) study as follows: site number (siteid): (b)(4). Unique patient id: (b)(6). Sae number: 1 diagnostic term to describe primary sae: edemato-ascites decompensation. Seriousness criteria: led to a death. Start date: (b)(6) 2019. Sae outcome: fatal. Severity (ctcae v5. 0 grade): (saesev): grade 4. Causality related to administration procedure (saecausdev): probably. Causality related to therasphere device (saecausmaa): probably. Incident: on (b)(6) 2019 (1st occurrence of ascites) at the first follow-up visit post treatment the patient presented, grade 3 ascites, jaundice with bilirubin at 76 umol/l (grade 3), ecog 2. A paracentesis was performed (3l), ascites non infected: liver function deterioration post sir, with ascites on (b)(6) 2019 (2nd occurrence of ascites) the patient was hospitalised for paracentesis, evacuation of 4 l of ascites with no infection. Weight loss of -15kg within 18days - anorexia, no asthenia. On (b)(6) 2019 the patient was hospitalised - (unknown adverse event), no ascites subtraction, prothrombin ratio (pr) 31%, on (b)(6) 2019 asthenia, diarrhoea, confusion, prescription of lactulose. On (b)(6) 2019: pr 41% (grade 2). Albumin 23 g/l (grade 3), bilirubin 86 micromo/l (grade 3), ast 140ui/ll, child c10 and on a ct scan on (b)(6) 2019 confirmed liver progression in the left liver. On (b)(6) 2019 the patient was hospitalised again: pr13%. Alteration of liver function test on (b)(6) 2019 the patient was re admitted to the hospital, no ascites subtraction, confusion (encephalopathy), asthenia, albumin 24 g/l, bilirubin 266 micromol/l, renal insufficiency with creatinine 272 micromol/l; grade 3 encephalopathy, ascites, child >c10 and the patient died the (b)(6) 2019. Ast=320 (grade 3), alt= 184 ui/l. The patient died the (b)(6) 2019. The investigator assessed the events as follows: ascite :serious. Probably related to administration and the therasphere device therasphere treatment: patient received one administration of therasphere the (b)(6) 2019, 5. 14 gbq in the right hepatic artery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002124543-2020-00002 |
| MDR Report Key | 9811688 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,S |
| Date Received | 2020-03-10 |
| Date of Report | 2020-02-13 |
| Date of Event | 2019-03-01 |
| Date Mfgr Received | 2020-02-13 |
| Date Added to Maude | 2020-03-10 |
| 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 |
| Manufacturer Country | US |
| Manufacturer Phone | 3311537 |
| 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 | 2020-03-10 |
| Model Number | 5.14 GBQ |
| 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; 2. Hospitalization; 3. Required No Informationntervention | 2020-03-10 |