THERASPHERE 5.14 GBQ N/A

MAUDE Adverse Event Report

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.

Event Text Entries

[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


MAUDE Entry Details

Report Number3002124543-2020-00002
MDR Report Key9811688
Report SourceFOREIGN,HEALTH PROFESSIONAL,S
Date Received2020-03-10
Date of Report2020-02-13
Date of Event2019-03-01
Date Mfgr Received2020-02-13
Date Added to Maude2020-03-10
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS SANDRA BAUSBACK-ABALLO
Manufacturer Street300 FOUR FALLS CORPORATE CENTE 300 CONSHOHOCKEN STATE ROAD
Manufacturer CityWEST CONSHOHOCKEN,, PA
Manufacturer CountryUS
Manufacturer Phone3311537
Manufacturer G1BIOCOMPATIBLES UK
Manufacturer StreetCHAPMAN HOUSE WEYDON LANE
Manufacturer CityFARNHAM, GU9 8QL
Manufacturer CountryUK
Manufacturer Postal CodeGU9 8QL
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTHERASPHERE
Generic NameYTTRIUM-90 GLASS MICROSPHERES, PRODUCT CODE: NAW
Product CodeNAW
Date Received2020-03-10
Model Number5.14 GBQ
Catalog NumberN/A
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBIOCOMPATIBLES UK LTD
Manufacturer AddressCHAPMAN HOUSE FARNHAM BUS PARK WEYDON LANE FARNHAM, GU9 8QL UK GU9 8QL


Patients

Patient NumberTreatmentOutcomeDate
101. Death; 2. Hospitalization; 3. Required No Informationntervention 2020-03-10

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