MAUDE Adverse Event Report: SIRTEX, WILMINGTON MA SIR-SPHERES MICROSPHERES; Y90 RESIN MICROSPHERES

Model Number	SIR-Y001
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pneumonia (2011); Respiratory Failure (2484)
Date of Event	05/04/2024
Type of Reportable Event	Death
Event or Problem Description
Patient family member stated in email: "what happens when a patient dies from radiation pneumonitis due to treatment? the patient passed mapping procedure however at the first sign of adverse reactions your researchers went out of their way to deny the treatment caused any ailments patient experienced for 2 months.Researchers actually tried to argue cause of death with icu drs treating the radiation pneumonitis.If they had intervened instead of denying from the first sign of respiratory problems, the patient may still be alive." patient family allege that patient died from radiation pneumonitis, following a sir-spheres investigational procedure.The family member does mention that the ir team that performed the procedure determined that patient did not have radiation pneumonitis.However, family still believes that patient suffered from this.Patient family member states that patient was seen at (b)(6) medical center (b)(6) in (b)(6) , with the mapping procedure on (b)(6) 2024 and the sir-spheres procedure on (b)(6) 2024.The family also states that dr.(b)(6) (resident) and dr.(b)(6) (attending) were the treating physicians for the procedures.Sirtex adverse event reports from the doorway90 investigational study show that patient was hospitalized (b)(6) 2024, for hypoxia and pneumonia.Ae reports from the study also state that patient conditions improved following the hospital stay.Patient family member stated that patient developed lung issues and pneumonia in (b)(6) 2024, was treated for these issues in (b)(6), and passed away on (b)(6) 2024.
Additional Manufacturer Narrative
This incident was reported by patient family member.The patient was enrolled in the doorway90 ide study of sir-spheres microspheres.The death occurred more than 100 days after investigational sirt procedure.Even though we do not yet know what caused or contributed to the death of this patient, as the person reporting it is not qualified to make a medical judgment, we are submitting this report as a precautionary step while we continue to investigate further.A full dhr review was performed for this batch, and did not result in any abnormal findings related to the manufacturing process.
Event or Problem Description
Patient passed away at beth israel hospital in plymouth, ma, on (b)(6) 2024, 109 days after investigational sirt procedure ((b)(6) clinical trial) which was performed on (b)(6) 2024, at beth israel deaconess medical center in boston ma.Patient developed progressive dyspnea since (b)(6) 2024, with multiple hospital admissions and was treated with antibiotics and nebulizers.The patient was admitted to the hospital on (b)(6) 2024, with hypoxia.The patient had chest x-rays on (b)(6) 2024, which confirmed pneumomediastinum and pneumopericardium.Patient required intubation from (b)(6) 2024, was taken off intubation on (b)(6) 2024 and reintubated from 26 apr 2024 to (b)(6) 2024.The patient was sedated and at one point required paralytic infusion for vent compliance from (b)(6) 2024.Patient continued with dyssynchrony on the ventilator with worsening pulmonary infiltrates and pulmonary compliance.The family decided for comfort measures on (b)(6) 2024 and the patient passed away due to respiratory failure.
Additional Manufacturer Narrative
Patient death occurred 109 days following the investigational y90 sirt procedure and was documented by the principal investigator (pi) of the (b)(6) ide study as due to respiratory failure.The clinical course for the patient involved multiple rounds of treatment, including antibiotics, nebulizers and steroids.The patient's condition continued to decline without a clear etiology.The patient's condition was likely confounded by advanced age (81), prior medical history and disease progression.The pi provided a final statement; the pre-y90 mapping procedure and post-y90 pet-ct showed a very low lung shunt fraction with a very low lung dose.According to the pi, the level of lung exposure to y90 has not been shown to result in radiation pneumonitis.As a result, the pi stated that it is unclear from the clinical course described by bid plymouth why the patient developed respiratory failure and why the respiratory symptoms progressed.The pi assessed the respiratory failure as not related to sirt mapping/planning procedure, not related to sirt implant procedure, and not related to the study device.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.There is no evidence to suggest that the device malfunctioned or was not used as intended.

• Brand Name: SIR-SPHERES MICROSPHERES
• Common Device Name: Y90 RESIN MICROSPHERES
• Manufacturer (Section D): SIRTEX, WILMINGTON MA; 16 upton dr. #2; wilmington MA 01887
• Manufacturer Contact: vana poovala ; 300 unicorn park; woburn, MA 01801 ; 7817213862
• MDR Report Key: 19613314
• Report Number: 3005579300-2024-00002
• Device Sequence Number: 20624971
• Product Code: NAW
• UDI-Device Identifier: M425SIRY0010
• UDI-Public: M425SIRY0010
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2024

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: Other
• Device Model Number: SIR-Y001
• Device Lot Number: SA028V03
• 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: 05/26/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/26/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 81 YR
• Patient Sex: Male