MAUDE Adverse Event Report: SIRTEX MEDICAL LIMITED SIR-SPHERES MICROSPHERES; YTTRIUM 90 RESIN MICROSPHERES

Model Number SIR-Y001

Device Problems Material Fragmentation (1261); Insufficient Information (3190)

Patient Problems Ulcer (2274); Weight Changes (2607); Device Embedded In Tissue or Plaque (3165)

Event Date 01/01/2018

Event Type  Injury  

Event Description

The patient was treated for mcrc.The patient was treated in a sequential lobar fashion with sir-spheres in (b)(6).At some point the patient developed a complication of treatment, gastric ulcer.The patient has had medical intervention and been hospitalized twice.Surgical intervention (jtube) is being considered.The patient's daughter reported this event.The below is an email from patient's daughter i am an oncology nurse at (b)(6) and have read many articles looking for further data on long term complications without much resolution.I am hoping you may be able to forward my email or direct me to someone that could provide further information regarding serious complications to the y-90 treatment.My mother had y-90 treatment for stage iv colon cancer with liver mets back in (b)(6) as they had to treat each lobe of the liver.The y-90 ended up in her stomach and she was hospitalized twice, has had four dilations and has been treated with a pharmacy of medication.She has since lost 40 pounds and i have taken her for two gi consultations to see if anyone could offer an additional information or treatment options.We have looked into j-tube or tpn but haven't got to that just yet, there was concern of placing a stent which was another discussion.I am grasping at straws to find out if anyone has provided alternative treatment options for this potential complication or if there is further data on long term affects from this complication as this has severely affected her quality of life as we both know is limited with her diagnosis.

• Brand Name: SIR-SPHERES MICROSPHERES
• Type of Device: YTTRIUM 90 RESIN MICROSPHERES
• Manufacturer (Section D): SIRTEX MEDICAL LIMITED; level 33, 101 miller street; north sydney, nsw 2060 ; AS 2060
• Manufacturer (Section G): SIRTEX WILMINGTON LLC; unit 2-4; 16 upon drive; wilmington MA 01887
• Manufacturer Contact: rachel tserng ; level 33, 101 miller street; niorth sydney, nsw 060 ; AS 060
• MDR Report Key: 8101634
• MDR Text Key: 128413922
• Report Number: 9710358-2018-00005
• Device Sequence Number: 1
• Product Code: NAW
• 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: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• 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: 08/03/2018
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization