MAUDE Adverse Event Report: BOLTON MEDICAL INC. TREO ABDOMINAL STENT-GRAFT SYSTEM; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	28-L2-24-160U
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The black lever broke while in use.

• Brand Name: TREO ABDOMINAL STENT-GRAFT SYSTEM
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): BOLTON MEDICAL INC.; 799 international parkway; sunrise FL 33325
• MDR Report Key: 16093966
• Report Number: 16093966
• Device Sequence Number: 20495971
• Product Code: MIH
• UDI-Device Identifier: 00843576152311
• UDI-Public: (01)00843576152311(11)2022-06-10(17)2025-06-09(10)2205260235
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/11/2022
• Report Date (Section F): 11/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 28-L2-24-160U
• Device Catalogue Number: 28-L2-24-160U
• Device Lot Number: 2205260235
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/04/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/04/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 126 KG
• Date Report Sent to FDA: 11/11/2022