MAUDE Adverse Event Report: GT MEDICAL TECHNOLOGIES GAMMATILE; RADIONUCLIDE BRACHYTHERAPY SEEDS

Model Number GT-001

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

Patient Problem Necrosis (1971)

Event Date 07/01/2020

Event Type  Injury  

Manufacturer Narrative

The patient was originally treated for a who 1 meningioma in (b)(6) 2018.A recurrence occured in (b)(6) 2019 when the patient was treated with repeat resection and full fractionated external beam radiation therapy.Additional recurrences occurred in (b)(6) 2019 and (b)(6) 2020.The treating physician did not feel repeat external beam radiation therapy was safe so resection with gammatile was performed.Radiation necrosis was identified and the patient required medical treatment to preclude permanent impairment.Due to the previous radiation treatment and this being re-radiation, it is not known whether gammatile caused or contributed to the radiation necrosis that was experienced.

Event Description

Patient experienced radiation necrosis after treatment with gammtile for recurrent brain tumor.

• Brand Name: GAMMATILE
• Type of Device: RADIONUCLIDE BRACHYTHERAPY SEEDS
• Manufacturer (Section D): GT MEDICAL TECHNOLOGIES; 350 hills street; suite 108; richland WA 99354
• Manufacturer (Section G): GT MEDICAL TECHNOLOGIES; 350 hills street; suite 108; richland WA 99354
• Manufacturer Contact: jessica newhard ; 1809 s. holbrook lane; suite 107; tempe, AZ 85281 ; 4802768609
• MDR Report Key: 16624919
• MDR Text Key: 312104539
• Report Number: 3014663932-2023-00011
• Device Sequence Number: 1
• Product Code: KXK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190839
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: GT-001
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention