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

Catalog Number 28-B2-26-100U

Device Problems Leak/Splash (1354); Activation, Positioning or Separation Problem (2906); Difficult to Open or Close (2921)

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

Event Date 01/11/2022

Event Type  Injury  

Event Description

Endoleak (type 1a): imaging performed prior to an evar was plain ct only, no contrast-enhanced ct was performed in view of the patient's low renal function.During the procedure, the ra was confirmed by angiography using contrast medium, and carbon dioxide angiography was used to confirm the bifurcation of the internal and external iliac arteries.In the evar, the treo main bifurcated stent graft was deployed from just below the lowest renal artery and two excluders were used for the legs of the treo.The procedure was completed successfully without any leakage.However, postoperative abdominal ultrasonography revealed a suspected type 1a endoleak.Post-deployment plain ct showed that the proximal portion of the treo stent-graft was not open completely.The preoperative plain ct revealed thin calcification-like substance in the aorta, and the neck of the aneurysm was presumed to have been originally dissected; it was suggested that the endoleak might have occurred due to insufficient deployment of the second stent in the treo stent-graft.On (b)(6) 2022, additional treatment was performed.No endoleak was observed by ultrasonography, however, contrast enhanced ct revealed a type 1a endoleak.Though it was dissection, by applying force to the neck of the treo stent-graft using a balloon the second stent was opened, and the shape of the neck was successfully corrected.Subsequently, the procedure was completed with the touch-up only.Comment from the physician: the first stent was fully open, however, the graft fabric of the first stent was not fully opened because it was pulled by the second stent, which was not fully opened.Ancillary devices used: excluder141000, excluder121200.Operation type: evar.(tc#:(b)(4)).Patient outcome - "no health damage to the patient.".

Event Description

Endoleak (type 1a): imaging performed prior to an evar was plain ct only, no contrast-enhanced ct was performed in view of the patient's low renal function.During the procedure, the ra was confirmed by angiography using contrast medium, and carbon dioxide angiography was used to confirm the bifurcation of the internal and external iliac arteries.In the evar, the treo main bifurcated stent graft was deployed from just below the lowest renal artery and two excluders were used for the legs of the treo.The procedure was completed successfully without any leakage.However, postoperative abdominal ultrasonography revealed a suspected type 1a endoleak.Post-deployment plain ct showed that the proximal portion of the treo stent-graft was not open completely.The preoperative plain ct revealed thin calcification-like substance in the aorta, and the neck of the aneurysm was presumed to have been originally dissected; it was suggested that the endoleak might have occurred due to insufficient deployment of the second stent in the treo stent-graft.On (b)(6), 2022, additional treatment was performed.No endoleak was observed by ultrasonography, however, contrast enhanced ct revealed a type 1a endoleak.Though it was dissection, by applying force to the neck of the treo stent-graft using a balloon the second stent was opened, and the shape of the neck was successfully corrected.Subsequently, the procedure was completed with the touch-up only.Comment from the physician: the first stent was fully open, however, the graft fabric of the first stent was not fully opened because it was pulled by the second stent, which was not fully opened.Ancillary devices used: - excluder141000.- excluder121200.Operation type: evar.(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 ; 9548389699
• MDR Report Key: 13387295
• MDR Text Key: 288471161
• Report Number: 2247858-2022-00014
• 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: 05/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/16/2024
• Device Catalogue Number: 28-B2-26-100U
• Device Lot Number: 2104060131
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/13/2022
• Initial Date FDA Received: 01/28/2022
• Supplement Dates Manufacturer Received: 01/13/2022
• Supplement Dates FDA Received: 05/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2021
• 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 Outcome(s): Other