MAUDE Adverse Event Report: BWXT Y-90 THERASPHERE (3 GBQ); MICROSPHERES RADIONUCLIDE

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

Patient Problems Abdominal Pain (1685); Hematoma (1884); Hemorrhage/Bleeding (1888); Hyperbilirubinemia (1903); Nausea (1970); Internal Organ Perforation (1987); Seroma (2069); Ascites (2596); Vascular Dissection (3160)

Event Date 09/06/2019

Event Type  Injury  

Manufacturer Narrative

Moctezuma-velazquez, c., et al.(2021).Selective internal radiation therapy for hepatocellular carcinoma across the barcelona clinic liver cancer stages.Digestive diseases and sciences, 66(3), pp.899-911.Date of event was approximated using date article was received for publication.

Event Description

It was reported via literature article that patient complications occurred.A retrospective study was performed to determine the efficacy and safety of selective internal radiation therapy (sirt) in hepatocellular carcinoma (hcc) across the barcelona clinic liver cancer (bclc) stages a, b, and c.Consecutive patients that received sirt between 2006 and 2016 at two centers in canada were evaluated.Therasphere was a device referenced within the study.Adverse events included: ascites, abdominal pain, nausea, seroma, hematoma, dissection, liver failure, perforation, abscess, post embolization syndrome (pes), hemorrhage, and hyperbilirubinemia.Fourteen deaths were attributed to treatment-related complications.Seventy-eight patients (59%) had an adverse event: 7, 35, and 36 patients in stages bclc a, b, and c, respectively (p=0.9).The most frequent were new-onset/worsening ascites in 49 (37%) patients, abdominal pain in 21 (16%), and nausea in 18 (14%).Five patients had local/technical complications related to the vascular access: one seroma, three hematomas, and one hepatic artery dissection.Forty-seven serious adverse events were distributed in forty-two (32%) patients: liver decompensation in 12 patients, gall bladder perforation in one, two patients developed a liver abscess, one was hospitalized for postembolization syndrome, and one because of bleeding at the site of vascular access.Twenty-four patients developed ascites requiring large volume paracentesis, and there were six cases of laboratory values indicating grade 3-4 toxicities (three cases of hyponatremia, two of hyperbilirubinemia, and one of elevated ast).Fourteen deaths (10%) were attributed to treatment-related complications, two due to the formation of a liver abscess, and 12 due to liver decompensation.Twelve of the 14 patients (86%) that died had child-pugh class b.

• Brand Name: Y-90 THERASPHERE (3 GBQ)
• Type of Device: MICROSPHERES RADIONUCLIDE
• Manufacturer (Section D): BWXT; 447 march road; kanata, on K2K 1 X8; CA K2K 1X8
• Manufacturer (Section G): BWXT; 447 march road; kanata, on K2K 1 X8; CA K2K 1X8
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12908289
• MDR Text Key: 281508332
• Report Number: 2134265-2021-14782
• Device Sequence Number: 1
• Product Code: NAW
• Combination Product (y/n): N
• Reporter Country Code: MX
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention