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

Model Number UNKNOWN

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

Patient Problems Abdominal Pain (1685); Gastritis (1874); Vomiting (2144)

Event Date 11/07/2017

Event Type  Injury  

Manufacturer Narrative

Review of the device history record resulted in no remarkable findings, this lot met the release criteria.Gastritis, vomiting, and abdominal pain are non-serious, anticipated events related to the use of therasphere and are listed in the product labeling.The events reported required medical intervention and this patient was hospitalized.The duration of hospitalization was not reported.Due to the limited information available, the duration of symptoms and hospitalization reported, these adverse events are considered serious.This event is being reported in an abundance of caution.The hospital and treating physician where the patient was admitted is not the hospital or physician that administered the therasphere treatment and reported this event.Follow up information was requested from the reporting physician, but to date, no additional information has been received.If additional information is received, a follow up report will be submitted.

Event Description

On 29-nov-2017 a physician reported that one of his patients experienced gastritis (no ulcers), vomiting, and abdominal pain post therasphere treatment.Treatment occurred on the (b)(6) 2017.The symptoms started almost immediately post discharge.The patient was subsequently brought to another hospital where he was admitted (the name of the hospital and treating physician was not reported).Although the duration of hospitalization was not reported, the symptoms had persisted, and the patient was reported to be still ill on the date the information was received (22 days post treatment).

Event Description

This is a follow up submitted to report additional information received from the physician on 18 apr 2018.Following the submission of an annual report to the fda, the fda requested additional detailed patient and procedure information to aid in reviewing the saes reported in the annual update.The request for additional information was sent to the physician via email on 22 mar 2018.A response was received from the physician on 01 apr 2018 with the following relevant information: patient and tumor characteristics: this patient was a 63 year old male with alcoholic and virus c related cirrhosis, with hepatocellular carcinoma involving the right liver lobe only and dominant mass 2.3cm.Previous treatment with deb-tace x2 with tace failure and tumor growth.Medical history also includes type ii diabetes, hypertension, glaucoma, long term opioid use, and history of hepatic decompensation with esophageal varices and encephalopathy.Refer to relevant tests/lab data and dates for pre- and post-procedural test results and lab data reported.Determination of dose activity for therasphere® treatment: the dose was calculated using the therasphere® package insert method.The target treatment tissue is the right liver lobe.The perfused liver volume is 1038 ml.The perfused liver mass is 1.069 kg.The pre treatment 99tc maa angiogram was performed on (b)(6) 2017.The lung shunt fraction was 7.5%.There was no extra hepatic digestive fixation of 99tc maa.The prescribed activity for therasphere® treatment was 2.8 gbq.This corresponds to 120 gy desired dose to the perfused liver.The corrected dose to the lungs during this treatment was 10.62 gy.The cumulative lung dose after this treatment was 10.62 gy.Note: this dose was administered under the direct supervision of company proctor.Follow up data: it was reported that a "few days" after treatment, the patient was admitted to a community hospital for an episode of upper gi bleeding requiring icu admission (not the hospital which administered therasphere).Endoscopy showing no varices or ulcers but gastritis.No transfusion performed, medical treatment given.Follow-up telephone consultation (b)(6) 2017: (3 weeks post treatment) subjective the patient missed follow-up appointment today.Patient has experienced abdominal bloating, indigestion, nausea and vomiting since the procedure.He is slowly improving but remains nauseated and has vomiting after eating.He does not have any antiemetics at home.Prescription of ondansetron 8mg tabs to take prn for nausea/vomiting.Follow-up visit (b)(6) 2017 (5 weeks post treatment): patient still reports symptom of flu and fatigue.Patient also endorses bilateral breast firmness and pain, nausea, and intermittent, unpredictable ruq abdominal pain.Denies fever, chill, sob, or chest pain.Examination was within the normal, blood test acceptable.Improvement of subjective complaints.Laboratory data reveals no significant change from before treatment.No further follow-up required.Condition resolved spontaneously.Assessment of the relationship to the device: the physician reported that the relationship to the device is probable because of the temporal relationship.Specifically to the radiation exposure.In the administering physician's opinion, it is likely an exacerbation of underlying comorbidities in addition to tumor lysis syndrome.Neither of which are unexpected but the combination resulted in a serious adverse event.

Manufacturer Narrative

The administering physician reported that the relationship to the device is probable because of the temporal relationship.Specifically to the radiation exposure.In the administering physician's opinion, it is likely an exacerbation of underlying comorbidities in addition to tumor lysis syndrome.Neither of which are unexpected but the combination resulted in a serious adverse event.The company's assessment is that the reported gastritis causing upper gi bleeding and hospitalisation (while serious) is not related to therasphere administration.Therasphere was injected into the right hepatic artery for a tumor in segment vii with no extra hepatic deposition.Vomiting and abdominal pain are non serious events that are related to therasphere and anticipated.No additional information is expected.

• Brand Name: THERASPHERE
• Type of Device: YTTRIUM-90 GLASS MICROSPHERES
• Manufacturer (Section D): BIOCOMPATIBLES UK LTD; farnham business park; weydon lane; farnham, surrey GU9 8 QL; UK GU9 8QL
• MDR Report Key: 7142380
• MDR Text Key: 95727888
• Report Number: 3002124543-2017-00053
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 04/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 11/17/2017
• Device Model Number: UNKNOWN
• Device Catalogue Number: N/A
• Device Lot Number: 1799374
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other