MAUDE Adverse Event Report: BIOCOMPATIBLES UK LIMITED Y-90 THERASPHERE; MICROSPHERES RADIONUCLIDE

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

Patient Problems Fever (1858); Necrosis (1971)

Event Date 12/02/2020

Event Type  Injury  

Manufacturer Narrative

(b)(6).(b)(4).

Event Description

(b)(6) clinical study: it was reported the patient experienced hepatic necrosis resulting in additional intervention.On (b)(6) 2020, the subject was enrolled in the (b)(6) study and the treatment with therasphere was performed on the same day.Therasphere infusion was in the left hepatic artery (irrespective of origin) segments ii, iii and iv and right anterior section segments v and viii.0.501 giga-becquerel (gbq) was administered to the right liver from the first vial and 0.77gbq was administered from the second vial.Total dose administered was 1.278gbq.Post treatment dosimetry documented a strong uptake of y-90 by the tumors.Dose to perfused liver was 121 gray (gy) and dose to perfused tumor was 206gy.On (b)(6) 2020 the patient received a subsequent therasphere treatment with administration of 0.341gbq in the right hepatic artery and 0.668gbq in the right posterior hepatic artery as a complementary treatment.On (b)(6) 2020, the subject returned for the first follow up visit.The patient was doing well and the response was assessed as a partial response.An additional follow up visit in (b)(6) 2020 revealed a partial response.On (b)(6) 2020, the subject presented with fever and suspicion of hepatic abscess and was hospitalized for further investigation and treatment.Covid-19 pcr test was (b)(6).Ct scan showed presence of an area of centro-hepatic necrosis.The subject was prescribed with tazocillin for 15 days.The subject was discharged from the hospital on (b)(6) 2020.On (b)(6) 2020, hepatic magnetic resonance imaging (mri) scan was performed and found stability of the centro-hepatic lesion and in favor of a range of necrosis.On (b)(6) 2020, the symptoms disappeared.There were no further patient complications reported.

Manufacturer Narrative

E1.Initial reporter address 1:(b)(6).G1.Mfr site zip/post code: (b)(6).

Event Description

Proactif clinical study.It was reported the patient experienced hepatic necrosis resulting in additional intervention.On (b)(6) 2020, the subject was enrolled in the proactif study and the treatment with therasphere was performed on the same day.Therasphere infusion was in the left hepatic artery (irrespective of origin) segments ii, iii and iv and right anterior section segments v and viii.0.501 giga-becquerel (gbq) was administered to the right liver from the first vial and 0.77gbq was administered from the second vial.Total dose administered was 1.278gbq.Post treatment dosimetry documented a strong uptake of y-90 by the tumors.Dose to perfused liver was 121 gray (gy) and dose to perfused tumor was 206gy.On (b)(6) 2020 the patient received a subsequent therasphere treatment with administration of 0.341gbq in the right hepatic artery and 0.668gbq in the right posterior hepatic artery as a complementary treatment.On (b)(6) 2020, the subject returned for the first follow up visit.The patient was doing well and the response was assessed as a partial response.An additional follow up visit in (b)(6) 2020 revealed a partial response.On (b)(6) 2020, the subject presented with fever and suspicion of hepatic abscess and was hospitalized for further investigation and treatment.Covid-19 pcr test was negative.Ct scan showed presence of an area of centro-hepatic necrosis.The subject was prescribed with tazocillin for 15 days.The subject was discharged from the hospital on (b)(6) 2020.On (b)(6) 2020, hepatic magnetic resonance imaging (mri) scan was performed and found stability of the centro-hepatic lesion and in favor of a range of necrosis.On (b)(6) 2020, the symptoms disappeared.There were no further patient complications reported.It was further reported that on (b)(6) 2020 the patient presented with fever and segment iv hepatic necrosis.

• Brand Name: Y-90 THERASPHERE
• 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; chapman house farnham bus prk; weydon lane, farnham; surrey ; UK
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14289424
• MDR Text Key: 290914964
• Report Number: 2134265-2022-04564
• 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: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2022
• 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; Hospitalization; Other
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 72 KG