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

Model Number UNKNOWN

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

Patient Problems Abdominal Pain (1685); Diarrhea (1811); Liver Damage/Dysfunction (1954)

Event Date 03/14/2019

Event Type  Injury  

Manufacturer Narrative

Btg medical assessment: (b)(6) with a history of (b)(6) and cirrhosis who developed a hepatocellular carcinoma of the right lobe of the liver (b)(6) 2019.Therasphere to the right lobe to 120 gy.Baseline of bilirubin 1.3-1.8, albumin 3.5 g/dl.On (b)(6) 2019 patient needed a medical consultation due to increasing abdominal distention bilirubin up to 2.7 from his baseline of 1.3-1.8, albumin 2.7, diarrhea and abdominal pain.Ct of the abdomen which demonstrated low volume ascites not amenable to paracentesis.Patient was hospitalized.For treatment of these discomfort.Patient's bowel symptoms improved, his abdominal pain improved and his liver enzymes stabilized.On (b)(6) 2019 discharge on patient's bilirubin was 2.0.Adverse event, severity, seriousness, causality, expectedness: hepatic failure, 2, yes, therasphere®, yes.Increased bilirubin, 2, yes, therasphere®, yes.Albumin decreased, 2, yes, therasphere®, yes.Diarrhea, n/a, no, hcc, yes.Abdominal pain, n/a, n/a, therasphere®, yes.No device malfunction was reported and no corrective and preventive action (capa) plan has been identified.The contract manufacturer of therasphere, (b)(4), was contacted with request to perform a batch review of lot 1999052.The following was provided by (b)(4) in response: (b)(4) (planned deviation) was written to document a temporary switch replacement for a sensor in the cell 25 passthrough door.No impact to the final product, the passthrough door operated normally with the replacement switch.(b)(4) was written to document that 8 dose vials and one vial containing a biological indicator (neg control) were dislodged from the vial tray following removal from the autoclave.Vial traceability was successfully recovered using 990797.Sop "therasphere vial traceability recovery method", therefore no impact to the final product.There were no other deviations associated with this batch.There were no excursions for viable and non-viable environmental monitoring.All vials met the acceptance criteria for mass and total activity.The steam sterilizer successfully completed the sterilization cycle and the biological indicators were negative at the end of the incubation period, indicating a successful sterilization cycle.Closures on the final product (crimped septum) were 100% visually inspected.One vial was rejected for unacceptable crimp and was rejected.All other vials met acceptance criteria.Final product was tested for endotoxin as per 990801.Stm and the test result was <0.06 eu/mg, which is below the specification limit of s0.08 eu/mg.Conclusion: no deficiencies were identified during the review of manufacturing lot 1999052 that could have contributed to the reported incident.No other information is available that could confirm/deny the alleged event.Hepatic decompensation; elevated bilirubin; abdominal pain are known adverse events listed in the ifu/risk management documentation.At this time this report is considered final.

Event Description

(b)(6) white, male with a history of (b)(6) and cirrhosis who developed a hepatocellular carcinoma of the right lobe of the liver.He was dispositioned to therasphere to the right lobe to 120 gy on (b)(6) 2019.Approximately 1 month after completion of therapy he noted increasing abdominal distention and presented to facility on (b)(6) 2019.Upon presentation he was found to have a rise in his bilirubin up to 2.7 from his baseline of 1.3-1.8, and a decline in his albumin 2.7 from his baseline of approximately 3.5.He had associated diarrhea and abdominal pain.After admission, patient underwent ct of the abdomen which demonstrated low volume ascites not amenable to paracentesis.Patient's bowel symptoms improved, his abdominal pain improved and his liver enzymes stabilized.At the time of discharge on (b)(6) 2019 patient's bilirubin was 2.0.Reporting physician assessed the event as serious due to patient hospitalization.Related to therasphere treatment.Additional information received: (b)(6) 2019: pain was dull right upper quadrant.No evidence extra hepatic bead deposition.

• 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, surrey GU9 8 QL; UK GU9 8QL
• Manufacturer (Section G): BIOCOMPATIBLES UK; chapman house; weydon lane; farnham, surrey GU9 8 QL; UK GU9 8QL
• Manufacturer Contact: sandra bausback-aballo ; 300 four falls corporate cente; 300 conshohocken state road; west conshohocken,, PA 19428-2998 ; 6103311537
• MDR Report Key: 8487313
• MDR Text Key: 141061004
• Report Number: 3002124543-2019-00029
• Device Sequence Number: 1
• Product Code: NAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H980006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 75 YR