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

Model Number OTHER PRODUCT

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

Patient Problems Pain (1994); Stomach Ulceration (4488)

Event Date 11/11/2020

Event Type  Injury  

Event Description

From dr.(b)(6), unfortunately, i have a patient that developed a large (7cm) duodenal ulcer 4 weeks post y90.Pancreatic primary controlled with a large hilar metastasis.Endoscopic biopsy confirms microspheres.Patient is still having pain 2 months post treatment.Double dose ppis, adding carafate.Discussing small bowel feeding tube versus surgery.Patient prefers conservative care.Any suggestions? i feel horrible, but the patient feels worse.Thanks.

• Brand Name: SIR-SPHERES Y90 RESIN MICROSPHERES
• Type of Device: SIR-SPHERES
• Manufacturer (Section D): SIRTEX, WILMINGTON MA; 16 upton dr. #2; wilmington MA 01887
• Manufacturer (Section G): SIRTEX, WILMINGTON MA; 16 upton dr. #2; wilmington MA 01887
• Manufacturer Contact: jeffrey cyr ; 300 unicorn park; woburn, MA 01801
• MDR Report Key: 11314976
• MDR Text Key: 234289609
• Report Number: 3005579300-2021-00001
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: OTHER PRODUCT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/14/2021
• Date Manufacturer Received: 01/14/2021
• 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
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other