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

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

Patient Problems Abdominal Pain (1685); Fever (1858); Inflammation (1932); Nausea (1970); Pseudoaneurysm (2605)

Event Date 01/14/2021

Event Type  Injury  

Manufacturer Narrative

Pellegrinelli, j.; chevallier, o.; manfredi, s.; dyagi-cochet, i.; tabouret-viaud, c.; nodari, g.; ghiringhelli, f.; riednger, j.-m.; popoff, r.; vrigneaud, j.-m.; et al.Transarterial radioembolization of hepatocellular carcinoma, liver-dominant hepatic colorectal cancer metastases, and cholangiocarcinoma using yttrium90 microspheres: eight-year single-center real-life experience.Diagnostics 2021, 11, 122.Https://doi.Org/10.3390/diagnostics11010122.Date of event was approximated using date of article publication.

Event Description

It was reported via journal article that patient complications occurred.To assess the safety and efficacy of transarterial radioembolization (tare) with yttrium-90 for hepatocellular carcinoma (hcc), liver-dominant hepatic colorectal cancer metastases (mcrc), and cholangiocarcinoma (cca), performed according to current recommendations, a single-center retrospective study was conducted in 70 patients treated with tare (hcc, n = 44; mcrc, n = 20; cca, n = 6).Two types of spheres, including therasphere microspheres, were used.Nausea, abdominal pain, fever, vascular-like pseudoaneurysm, radiation-induced cholecystitis and angiocholitis were noted to have occurred.

• Brand Name: Y-90 THERASPHERE (3 GBQ)
• Type of Device: MICROSPHERES RADIONUCLIDE
• Manufacturer (Section D): BIOCOMPATIBLES UK LIMITED; chapman house, farnham bus prk; weydon lane, farnham; surrey gu9 8ql ; UK
• Manufacturer (Section G): BIOCOMPATIBLES UK LIMITED; farnham business park; weydon lane, farnham; surrey GU9 8 QL; UK GU9 8QL
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12994221
• MDR Text Key: 282186371
• Report Number: 2134265-2021-15604
• Device Sequence Number: 1
• Product Code: NAW
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 12/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2021
• 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): Required Intervention