THERASPHERE UNKNOWN N/A

MAUDE Adverse Event Report

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.

Event Text Entries

[141064365] The events were reported through a retrospective clinical trial. Btg medical assessment: patient is a subject enrolled in the (b)(6) study: male (b)(6), white, hcc diagnosed (b)(6) 2015 with radiology, one nodule in segment viii, albumin 30g/l, afp 1835 ng/ml, child a6 bclc a. First therasphere? Administration (b)(6) 2015: patient was diagnosed with sepsis (b)(6) 2015 and (approximately 10 days after treatment)approximately 10 days after treatment, he was admitted to an outside hospital in (b)(6) for fatigue, weakness and concern over infection with sirs physiology. He received a course of antibiotics and was discharged with a home nurse as well as occupational therapy. At the follow up visit (b)(6) 2016, hematology tests were within the limits of normal an afp has decrease to 21 ng/ml. Conclusion: syndrome that combines fatigue and fever, in accordance with diagnosis of systemic inflammatory response syndrome (sirs). This is an inflammatory state affecting the whole body in response to an infectious or non infectious insult. Antibiotics were provided, however the occurrence of an infection was not documented, event = sirs + proven of probable infection = sepsis, severity grade 3, serious ae, which lead to hospitalization and medical intervention, anticipated ae, related to therasphere? Administration. 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. Sepsis is an anticipated adverse event as per the ifu/risk management documentation.. At this time this report is considered final.
Patient Sequence No: 1, Text Type: N, H10


[141064366] Subject (b)(6) is an (b)(6) white male patient enrolled in the (b)(6) study. Medical history of: alcohol abuse; cirrhosis; diabetes; (b)(6); smoker; other - fissure anal; barret oesophagus; meningitis; arthritis. Hcc diagnosed on (b)(6) 2015, one nodule in segment viii, therasphere? Administered (b)(6) 2015, total administered activity gbq 1. 8572, lung shunt fraction 7. 54%. Patient was diagnosed with sepsis (b)(6) 2015 and (approximately 10 days after treatment) patient was admitted to an outside hospital in for fatigue, weakness and concern over infection with sirs physiology. He received a course of antibiotics and was discharged with a home nurse as well as occupational therapy. He tells me that he suffered severe fatigue, which has improved but certainly not resolved by today. Patient was discharged (b)(6) 2015. Outcome: resolved. The events were not reported to btg by the investigator in 2015.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3002124543-2019-00031
MDR Report Key8487620
Report SourceHEALTH PROFESSIONAL,STUDY
Date Received2019-04-05
Date of Report2019-03-29
Date of Event2015-12-21
Date Mfgr Received2019-03-29
Date Added to Maude2019-04-05
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 194282998
Manufacturer CountryUS
Manufacturer Postal194282998
Manufacturer Phone6103311537
Manufacturer G1BIOCOMPATIBLES UK
Manufacturer StreetCHAPMAN HOUSE WEYDON LANE
Manufacturer CityFARNHAM, SURREY 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 Received2019-04-05
Model NumberUNKNOWN
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, SURREY GU9 8QL UK GU9 8QL


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention 2019-04-05

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