MAUDE Adverse Event Report: BIOCOMPATIBLES UK LTD THERASPHERE; YTTRIUM-90 GLASS MICROSPHERES

Model Number 3.69GBQ

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Fever (1858); Liver Damage/Dysfunction (1954); Ascites (2596)

Event Date 04/27/2020

Event Type  Injury  

Manufacturer Narrative

Company medical assessment comments: patient received administration of 3.69 gbq of therasphere® on the (b)(6) 2019 in the femoral artery.On (b)(6) 2019 the patient had a follow-up visit, ecog 1, albumin 29 g/l, bilirubin not done, progression of the disease on the imaging, it is of note that the pre-treatment imaging was done in (b)(6) 2019 and ts was administered in (b)(6) 2019, then 4 months after on (b)(6) 2020 the patient was hospitalized.Oedematous ascitic decompensation evolving for 3 weeks with 9 kg weight gain accompanied by asthenia, anorexia and fever at 38 °c with febrile seizures.Alteration of renal function no infection found in ascites.Improvement of renal function under diuretics.Sars cov2 screening performed.Pcr result was negative.Worsening of hepatic function (b9 at admission, c11 at discharge) and cirrhosis decompensation conducing mcm to decide supportive care.To be re-evaluated in case of improvement after sepsis.The investigator has listed the causality as not related to the administration procedure but possibly related to the therasphere® device action taken: concomitant medication and ascites puncture.The patient was evaluated in (b)(6) 2019 and it was considered that there was a disease progression, therefore the event is related to worsening of liver function due to progression of the cancer, and the device.The reported adverse events are known inherent risks associated with sirt listed in the ifu/risk managment documentation.No device malfunction was reported or identified.No batch review was possible for this case as the batch number has not been provided and the product was not returned for evaluation (device remains implanted in the patient).No corrective/preventative action has been identified.Should we receive any information to enable further investigations, a follow-up report will be submitted.At this time this report i considered final.

Event Description

Auto-notification received from datatrak for subject enrolled on proactif study: patient (b)(6) received administration of 3.69 gbq of therasphere® on the (b)(6) 2019 in the femoral artery.On (b)(6) 2019 the patient had a follow-up visit, ecog 1, albumin 29 g/l, bilirubin not done, progression of the disease on the imaging, it is of note that the pre-treatment imaging was done in (b)(6) 2019 and therasphere was administered in (b)(6) 2019, then 4 months after.On (b)(6) 2020 the patient was hospitalized.Oedematous ascitique decompensation evolving for 3 weeks with 9 kg weight gain accompanied by asthenia, anorexia and 38 °c febrile seizures with febrile seizures.Alteration of renal function.No infection found in ascites.Improvement of renal function under diuretics.Sars cov2 screening performed.Pcr result was negative.Worsening of hepatic function (b9 at admission, c11 at discharge) and cirrhosis decompensation conducing mcm to decide supportive care.To be re-evaluated in case of improvement after sepsis.The investigator has listed the causality as not related to the administration procedure but possibly related to the therasphere® device action taken: concomitant medication and ascite puncture.

Manufacturer Narrative

Company assessment comment: worsening of hepatic function (b9 at admission, c11 at discharge) and cirrhosis decompensation conducing physician to decide supportive care.To be re-evaluated in case of improvement after sepsis.After reevaluation the patient has progressed, the investigator assessed the event as not related to the device but related to progression of the disease that cause the liver function deterioration patient died on the (b)(6) 2020.Additional information received from the investigator has listed the causality as not related to the administration procedure and thera sphere device.The reported adverse events are known inherent risks associated with sirt listed in the ifu/risk management documentation.No device malfunction was reported or identified.No batch review was possible for this case as the batch number has not been provided and the product was not returned for evaluation (device remains implanted in the patient).No corrective/preventative action has been identified.At this time this report i considered final.

Event Description

Auto-notification received from datatrak for subject enrolled on proactif study: a patient has reported a serious adverse event.Please see the following for more information.Site number (siteid): 250068.Unique patient id (usubjid): (b)(6).Sae number (saespid): 1.Diagnostic term to describe primary sae (saeterm): oedematous ascitic decompensation.Seriousness criteria (saecrit): led to a serious deterioration in health.Start date (dd-mmm-yyyy or un-mmm-yyyy) (saeadmdat): (b)(6) 2020.Sae outcome (saeout): not resolved.Severity (ctcae v5.0 grade): (saesev): grade 2.Causality related to administration procedure (saecausdev): not related.Causality related to therasphere device (saecausmaa): possibly.Patient received administration of 3.69 gbq of therasphere® on the (b)(6) 2019 in the femoral artery.On (b)(6) 2020 the patient was hospitalized.Oedematous ascitique decompensation evolving for 3 weeks with 9 kg weight gain accompanied by asthenia, anorexia and 38 °c febrile seizures.No infection found in ascites.Improvement of renal function under diuretics.Sars cov2 screening performed.Pcr result was negative.Worsening of hepatic function (b9 at admission, c11 at discharge) and cirrhosis decompensation conducing mcm to decide supportive care.The investigator has listed the causality as not related to the administration procedure but possibly related to the therasphere® device action taken: concomitant medication and ascite puncture.Updated: 03-jul-2020.Event description: on (b)(6) 2020, 4 months post therasphere administration, the patient was hospitalized due to ascites and eodema (edemato-ascitic decompensation) evolving for 3 weeks with 9 kg weight gain accompanied by asthenia, anorexia and 38 °c temperature with febrile seizures.Alteration of renal function.No infection found in ascites.Improvement of renal function under diuretics.Sars cov2 screening performed.Pcr result was negative.Worsening of hepatic function (b9 at admission, c11 at discharge) and cirrhosis decompensation conducing mcm to decide supportive care.To be re-evaluated in case of improvement after sepsis.The investigator has listed the causality as not related to the administration procedure or thera sphere device.Event linked to disease progression , event led to death action taken: concomitant medication and ascites puncture.

• Brand Name: THERASPHERE
• Type of Device: YTTRIUM-90 GLASS MICROSPHERES
• Manufacturer (Section D): BIOCOMPATIBLES UK LTD; chapman house farnham bus park; weydon lane; farnham, GU9 8 QL; UK GU9 8QL
• MDR Report Key: 10142027
• MDR Text Key: 195950809
• Report Number: 3002124543-2020-00014
• Device Sequence Number: 1
• Product Code: NAW
• Combination Product (y/n): N
• PMA/PMN Number: H980006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Type of Report: Initial,Followup
• Report Date: 07/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3.69GBQ
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Weight: 96