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

Model Number SIR-Y001

Device Problem Insufficient Information (3190)

Patient Problems Abscess (1690); Sepsis (2067)

Event Date 09/23/2023

Event Type  Injury  

Event Description

Patient underwent three sessions of tace and one session of y90.Routine imaging surveillance was performed following each therapy session.No significant changes to tumor size were noted.Development of abscess and sepsis within the treated tumor was seen.Following y90, patient underwent multiple percutaneous drainage procedures.Patient condition deteriorated and the family decided against further interventions.

Manufacturer Narrative

Investigations could not be undertaken and conclusions could not be drawn due to lack of details related to the incident and the device used (no information was available/received on lot/batch number of device used or how the device was used).This adverse event was presented as part of a poster presentation at an ir conference with very limited information.Sirtex attempted to contact the person(s) alleging the incident but no response.No information was available/received about which healthcare provider or facility treated the patient.

• Brand Name: SIR-SPHERES MICROSPHERES
• Type of Device: Y90 RESIN MICROSPHERES
• Manufacturer (Section D): SIRTEX, WILMINGTON MA; 16 upton dr. #2; wilmington MA 01887
• Manufacturer Contact: 300 unicorn park; woburn, MA 01801 ; 7817213862
• MDR Report Key: 17996860
• MDR Text Key: 326409655
• Report Number: 3005579300-2023-00001
• Device Sequence Number: 1
• Product Code: NAW
• UDI-Device Identifier: M425SIRY0010
• UDI-Public: M425SIRY0010
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P990065
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SIR-Y001
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other