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

Model Number SIR-Y001

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Liver Damage/Dysfunction (1954); Ascites (2596)

Event Date 12/01/2015

Event Type  Injury  

Manufacturer Narrative

Implanted device unable to be returned.

Event Description

Male patient with crclms was treated with sir-spheres y-90 resin microspheres in (b)(6) 2015 with 2gbq of activity administered to the right lobe, which the reporter believed was approximately two times more than they considered appropriate.The reporter stated he was not the treating physician but became aware of the patient having developed radioembolization induced liver disease (reild) when he was performing the diagnostic follow-up imaging, which demonstrated that the patient's right hepatic lobe had evidence of radiation injury and the patient had developed florid abdominal ascites.The reporter stated that the patient had experienced cr on follow-up imaging but that he had developed chronic ascites requiring weekly paracentesis (performed by the reporter).The patient otherwise had relatively normal liver function, however in the absence of radiological evidence of tumour progression, the ascites was considered to be likely due to reild from sirt with sir-spheres microspehres.

• 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 upton drive; wilmingotn MA 01887
• Manufacturer Contact: gary burgess ; level 33, 101 miller street; north sydney, nsw 2060 ; AS 2060 ; 2 9964841
• MDR Report Key: 6074868
• MDR Text Key: 59006922
• Report Number: 9710358-2016-00002
• 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: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: SIR-Y001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/20/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2015
• 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): Required Intervention; Disability