MAUDE Adverse Event Report: SIRTEX WILMINGTON LLC SIR-SPHERES Y-90 MICROSPHERES; YTTRIUM-90 RESIN MICROSPHERES

Model Number	SIR-Y001
Health Effect - Clinical Codes	Death (1802); Ulcer (2274)
Date of Event	10/01/2019
Type of Reportable Event	Death
Event or Problem Description
Patient had a pre-existing issue with ulcers.Patient treated with sir-spheres on (b)(6) 2019, and experienced gastric ulcer after the procedure.Patient passed away on (b)(6) 2019.We requested additional information from the physician and have not obtained any further details.

• Brand Name: SIR-SPHERES Y-90 MICROSPHERES
• Common Device Name: YTTRIUM-90 RESIN MICROSPHERES
• Manufacturer (Section D): SIRTEX WILMINGTON LLC; 16 upon dr.; no. 2-4; wilmington MA 01887
• MDR Report Key: 9508723
• Report Number: 3005579300-2019-00009
• Device Sequence Number: 13805516
• Product Code: NAW
• UDI-Device Identifier: M425SIRY0010
• UDI-Public: M425SIRY0010
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P990065
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/23/2019

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 Model Number: SIR-Y001
• Device Catalogue Number: SIR-Y001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2019
• Initial Report FDA Received Date: 12/22/2019
• 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