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

Catalog Number 28-L2-13-140U

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/06/2023

Event Type  malfunction  

Event Description

Broken: before the treo leg was inserted, flush was performed from the two-way check valve.When the outer sheath was flushed by pressing the syringe due to injection pressure, a snapping sound was heard from the injection area, resulting in separation of the front nose cap.The physician determined that the cap separation would not affect the patient and used the treo leg to continue the procedure.The treo leg was implanted, and the procedure was successfully completed without any endoleak.Operation type: evar.No blood loss.(b)(4).Patient outcome: "no health damage to the patient.".

Event Description

Broken: before the treo leg was inserted, flush was performed from the two-way check valve.When the outer sheath was flushed by pressing the syringe due to injection pressure, a snapping sound was heard from the injection area, resulting in separation of the front nose cap.The physician determined that the cap separation would not affect the patient and used the treo leg to continue the procedure.The treo leg was implanted, and the procedure was successfully completed without any endoleak.Operation type: evar no blood loss tc (b)(4) patient outcome - "no health damage to the patient.".

• Brand Name: TREO ABDOMINAL STENT-GRAFT SYSTEM
• Type of Device: STENT, ENDOVASCULAR GRAFT, AORTIC
• Manufacturer (Section D): BOLTON MEDICAL, INC.; 799 international parkway; sunrise FL 33325
• Manufacturer Contact: megan indeglia ; 799 international parkway; sunrise, FL 33325 ; 9548339699
• MDR Report Key: 16280061
• MDR Text Key: 308591037
• Report Number: 2247858-2023-00028
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P190015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/19/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 28-L2-13-140U
• Device Lot Number: 2109130105
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/10/2023
• Initial Date FDA Received: 02/01/2023
• Supplement Dates Manufacturer Received: 01/10/2023
• Supplement Dates FDA Received: 04/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2021
• 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 Age: 99 YR