MAUDE Adverse Event Report: SIRTEX MEDICAL PTY LIMITED SIR-Spheres microspheres; Microspheres Radionuclide

Model Number	SIR-Y001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pneumonia (2011); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A comprehensive device history record review was performed for this product batch and did not result in any abnormal findings related to the manufacturing process.Sirtex has learned that the subject was in fact discharged on (b)(6) 2025.Prescribed medication (prednisone) is still on going and with the anticipated end date of (b)(6) 2025.
Event or Problem Description
Doorway90 clinical study serious adverse event of radiation pneumonia (grade 3) leading to persistent or significant disability/incapacity considered by administrating physician to be probably related to the sir-spheres implant procedure.On 05may2025, research staff were reviewing the subject's medical records and the subject was admitted into the hospital on (b)(6) 2025 for atypical pneumonia per her emr.Research staff called and spoke with the patient the same day (b)(6) 2025).The subject shared that they were experiencing shortness of breath for a while but had been attributing it to their atrial fibrillation.The subject was admitted to an outside hospital local to their area.The subject was diagnosed with radiation pneumonia in the lungs.The subject was hospitalized for 14 days but expressed that they were feeling better and may get discharged that day (b)(6) 2025).The subject was prescribed prednisone (60 mg).Relatedness of the adverse event to the sirt mapping/planning procedure: not related.Relatedness of the adverse event to the sirt implant procedure: probably.Relatedness of the adverse event to the study device: definitely.

• Brand Name: SIR-Spheres microspheres
• Common Device Name: Microspheres Radionuclide
• Manufacturer (Section D): SIRTEX MEDICAL PTY LIMITED; 207 pacific highway; shop 6; st. leonards 2065 ; AS 2065
• Manufacturer Contact: melissa sanchez ; 300 unicorn park drive; fl. 2; woburn, MA 01801
• MDR Report Key: 22529918
• Report Number: 9710358-2025-00002
• Device Sequence Number: 12766756
• Product Code: NAW
• UDI-Device Identifier: 00850014612030
• UDI-Public: (01)00850014612030(11)250709(17)250717(10)SG017V05
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P990065
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/19/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/17/2024
• Device Model Number: SIR-Y001
• Device Lot Number: SG017V05
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2025
• Supplement Date Received by Manufacturer: Not provided; 07/31/2026
• Initial Report FDA Received Date: 07/17/2025
• Supplement Report FDA Received Date: 08/19/2026; 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/09/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ATORVASTATIN (PRE-EXISTING CONDITION); BUMETANIDE (PRE-EXISTING CONDITION); DIGOXIN (PRE-EXISTING CONDITION); DULOXETINE (PRE-EXISTING CONDITION); ELIQUIS (PRE-EXISTING CONDITION); HUMALOG MIX 75-25 KWIKPEN (PRE-EXISTING CONDITION); HYDROMORPHONE (PRE-EXISTING CONDITION); LEVOTHYROXINE (PRE-EXISTING CONDITION); LOSARTAN (PRE-EXISTING CONDITION); SEMAGLUTIDE (PRE-EXISTING CONDITION); TAPENTADOL (PRE-EXISTING CONDITION); XIGDUO XR (PRE-EXISTING CONDITION)
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 270 LB
• Patient Race: White