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

Model Number 4 GBQ

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

Patient Problems Dyspnea (1816); Tachycardia (2095); No Code Available (3191)

Event Date 07/24/2019

Event Type  Death  

Manufacturer Narrative

Btg medical assessment: female patient aged (b)(6) years old.Treatment with therasphere for met of bladder cancer.Therasphere treatment (b)(6) 2019, unknown disease, unknown site of administration.Lot 1999325 24 4gbq lot 1999325 62 7gbq ordered.Medical history: metastatic (urothelial) bladder cancer with bone, lung, liver mets, iron def anemia, autoimmune hepatitis.Concomitant meds: cholecalciferol powder pravastatin sodium 20 mg oral tablet.Unknown: site of administration.Activity administered, lung shunting, extra hepatic deposition.If coils were put in place to prevent extra hepatic therasphere deposition coils put in place to prevent extra hepatic therasphere deposition.Patient experienced immediately after therasphere administration elevated heart rate, shortness of breath and flushing.The patient had no cardiac history and no recorded allergies to contrast.The symptoms continued for 30-40 minutes and resolved no foreign body reaction is described with therasphere the causality is more likely related to contrast product or vasodilatation drugs that are often used during hepatic angiography.There was no device failure or malfunction.The patient passed on (b)(6) 2019 of a perforated bowel, (9 days after therasphere administration).There are several causalities possible but with, the current information it is not possible to make a conclusion.Additional information has been requested as follows: a bowel perforation because of coils placement during the work up to prevent extra hepatic deposition of ts.A bowel perforation because of the extra hepatic deposition of ts during the administration procedure.A bowel perforation because disease progression, or mesenteric ischemia or any other concomitant disease.With the available information, the worst case scenario has been considered and the sae causality is therasphere administration.No device malfunction was reported and no corrective and preventive action (capa) plan has been identified.Lot 1999325 24 and 1999325 62 was provided and a batch history review will be performed - findings to be supplied in a follow up report.Additional information has been requested regarding the patient treatment, should we receive responses, we will include in our follow up report.No other information is available at this time that could confirm/deny any causal link to therasphere regarding the alleged event.

Event Description

The patient received a therasphere administration and almost immediately experienced elevated heart rate, shortness of breath and flushing.The patient had no cardiac history and no recorded allergies to contrast.The symptoms continued for 30-40 minutes and resolved.The patient has had no further symptoms since the treatment was given sometime last week.The patient did not receive any post-treatment imaging other than an ekg which was normal.The physician indicated that the patient's lsf was not high and in his opinion not likely to have been the cause, however, there was no chest x-ray, spect or pet ct to confirm the deposition of the spheres.Additional information received 06-aug-2019.Patient passed away at the weekend ((b)(6) 2019) - reporter stated death was unrelated to therasphere.Additional information received 08-aug-2019.Female patient aged (b)(6) years old.Therasphere treatment (b)(6) 2019.Lot 1999325 24 4gbq, lot 1999325 62 7gbq.Medical history: metastatic (urothelial) bladder cancer with bone, lung, liver mets, iron def anemia, autoimmune hepatitis.Concomitant meds: cholecalciferol powder pravastatin sodium 20 mg oral tablet.Shortly after administration of therasphere, the patient experienced shortness of breath, became tachycardic, and stated she did not feel well.Dr was concerned that the therasphere had something to do with the patient's cardiac event.Dr was very concerned of the shortness of breath and tachycardia following therasphere treatment.Medical intervention required - ekg, close cardiac monitoring.Patient outcome: after about an hour post therasphere the patient's heart rate and breathing had normalized.The patient passed on (b)(6) 2019 of a perforated bowel, which the dr believed to be unrelated to the therasphere treatment.

Manufacturer Narrative

A batch record review of (lot 1999325, vial 24, 4gbq; lot 1999325, vial 62, 7gbq was performed on 20-sep-2019 as follows: batch 1999325 was reviewed with the following results: 1.Batch: 1999325; manufactured: 2019-07-11; calibration date: 2019-07-14; expiry date: 2019-07-26.2.There were 2 deviations with this batch, neither impacting product quality: a.Dn6324 - planned deviation for the inclusion of 2 biological indicators in each autoclave load.B.Dn6357 - the incorrect version was used for printing of the calibration data sheets (cdss); all information on the cdss was verified to be accurate.3.Lal assay for endotoxin result was <0.06 eu/mg, which is below the specification limit of +/-0.08 eu/mg, per 990801.Stm.4.The autoclave cycle was acceptable per 100585.Sop and the biological indicators were negative (no growth) at the end of the incubation period per 100870.Stm.5.Vials 24 and 62 had acceptable masses of microspheres per 990790b.Pcr.6.Vials 24 and 62 met acceptance criteria for total activity per 990790e.Pcr.7.There were no excursions associated with this batch for non-viable or viable environmental monitoring of the manufacturing facility per 100014.Sop and 990833.Pcr.This complaint has been classified as 'unconfirmed'.Following batch review - no change to previous btg medical assessment.No device malfunction was reported and no corrective and preventive action (capa) plan has been identified.No other information is available at this time that could confirm/deny any causal link to therasphere regarding the alleged event.This report is considered final.

• Brand Name: THERASPHERE
• Type of Device: 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: 8939342
• MDR Text Key: 160841909
• Report Number: 3002124543-2019-00054
• 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
• Type of Report: Initial,Followup
• Report Date: 09/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 4 GBQ
• Device Catalogue Number: N/A
• Device Lot Number: 1999325
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 79 YR