MAUDE Adverse Event Report: BIOCOMPATIBLES UK LTD THERASPHERE; YTTRIUM-90 GLASS MICROSPHERES, PRODUCT CODE: NAW

Model Number	4.1 GBQ
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Rupture (2208); Laceration(s) of Esophagus (2398)
Date of Event	11/01/2011
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Btg medical assessment: patient: (b)(6) is a (b)(6) male, with a medical history of obesity, diabetes, liver cirrhosis caused by obesity, nash, alcohol complicated with portal hypertension (oesophagus varices in (b)(6) 2011, low platelet at 59 giga/l) diagnosed with hcc: 23-jun-2011 complicated with pvt location: invasion of (or tumour thrombus in) second order branches of the portal vein.No prior sorafenib treatment before therasphere treatment and no disease specific surgery.Patient has bilobar disease.Target lesion: in the right liver.Treated with therasphere (b)(6) 2011, in the right liver.Activity start of treatment: 4.11 gbq.No residuals remaining after delivery.Lung shunt fraction 1.6%.No concomitant medications.Patient presented with rupture of esophageal varices on (b)(6) 2011.Reported as an sae due to initial or prolonged hospitalization.Grade 3.End date (b)(6) 2011.Patient recovered/resolved.Patient presented again with rupture of esophageal varices on (b)(6) 2011.Reported as an sae due to initial or prolonged hospitalization.Grade 4.End date (b)(6) 2012.Patient recovered/resolved.There is no information about transfusion, or endoscopic procedure for this patient.It was reported that the patient died (b)(6) 2012 - no causal relationship was provided.In the evaluation scan performed at day 42 after treatment administration; it was documented that there was a new bone lesion and an increased in size of the target lesion, rupture of esophageal varices: severity grade 3; serious: yes, hospitalisation to prevent permanent alteration of body function; anticipated; related: device cause increase of pre existing portal hypertension.Rupture of esophageal varices: severity grade 4; serious: yes, hospitalisation to prevent permanent alteration of body function; anticipated; related: device cause increase of pre existing portal hypertension.Death: severity grade 5; serious; anticipated; causality - unknown.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.
Event or Problem Description
Auto-notification received from datatrak site # 250011, subject number: b)(6) 2019.A subject has reported a related adverse event.Please see the following for more information.Site #: 250011.Subject number: (b)(6).Adverse event: rupture of esophageal varices.Start date: (b)(6) 2011.Relationship to study treatment: probably related.Serious adverse event: yes.Outcome: recovered/resolved.Pt: (b)(6) male diagnosed with hcc: (b)(6) 2011 with presence of portal hypertension pvt location: invasion of (or tumour thrombus in) second order branches of the portal vein etiologic associations with hcc: liver cirrhosis, non-alcoholic fatty liver disease, alcoholism.No prior sorafenib treatment before therasphere treatment and no disease specific surgery, patient has bilobar disease, target lesion: liver, right lobe.Treated with therasphere (b)(6) 2011.Activity start of treatment: 4.11 gbq.No residuals remaining after delivery.Lung shunt fraction 1.6%.No concomitant medications.Patient presented with rupture of esophageal varices on (b)(6) 2011.Reported as a sae due to initial or prolonged hospitalization.Grade 3.End date (b)(6) 2011.Patient recovered/resolved.Patient presented again with rupture of esophageal varices on (b)(6) 2011.Reported as a sae due to initial or prolonged hospitalization.Grade 4.End date (b)(6) 2012.Patient recovered/resolved.No action taken.It was reported that the patient died (b)(6) 2012 - no causal relationship was provided.The events were not reported to btg in 2011.Rupture of esophageal varice (hemorrhage, not otherwise specified and death.Not otherwise specified) are anticipated adverse events listed in the risk management documentation/study protocol.No reported device malfunction.

• Brand Name: THERASPHERE
• Common Device Name: YTTRIUM-90 GLASS MICROSPHERES, PRODUCT CODE: NAW
• Manufacturer (Section D): BIOCOMPATIBLES UK LTD; chapman house farnham bus park; weydon lane; farnham, GU9 8 QL; UK GU9 8QL
• MDR Report Key: 9166359
• Report Number: 3002124543-2019-00060
• Device Sequence Number: 2591870
• Product Code: NAW
• UDI-Device Identifier: 05060116920352
• UDI-Public: 05060116920352
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: H980006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,s
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 4.1 GBQ
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2019
• Initial Report FDA Received Date: 10/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Hospitalization
• Patient Age: 56 YR