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

Model Number SIR-Y001

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

Patient Problems Death (1802); Ulcer (2274)

Event Date 10/01/2019

Event Type  Death  

Event 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
• Type of Device: YTTRIUM-90 RESIN MICROSPHERES
• Manufacturer (Section D): SIRTEX WILMINGTON LLC; 16 upon dr.; no. 2-4; wilmington MA 01887
• Manufacturer (Section G): SIRTEX WILMINGTON LLC; 16 upon dr.; no 2-4; wilmington MA 01887
• Manufacturer Contact: rachel tserng ; 300 unicorn park dr.; woburn, MA 01801
• MDR Report Key: 9508723
• MDR Text Key: 172370256
• Report Number: 3005579300-2019-00009
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SIR-Y001
• Device Catalogue Number: SIR-Y001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/27/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death