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

Catalog Number	28-B2-26-120U
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint in this report was received on december 18, 2024, with an awareness date of october 01, 2024.Therefore, the emdr submission was reported past the 30-day time frame.Bolton medical, inc.(d/b/a terumo aortic), herein known as the "company", is submitting this report pursuant to 21 cfr part 803, has made reasonable efforts to obtain complete information, and has provided as much as is available to the company as of the submission date of this report.This report is based on information obtained by the company, which may not have been able to fully investigate or verify prior to the date the report was required by the regulations.Any required fields that are unpopulated are blank because the information is currently unknown, unavailable, or not applicable.This report does not constitute an admission or a conclusion by anyone that the device caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the certain regulations, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
Event or Problem Description
"describe the event or problem: during the case, the treo abdominal stent-graft system was stuck on delivery.What was the original intended procedure? : fenestrated endovascular repair of visceral and infrarenal aorta percutaneous including four or more visceral artery endoprostheses with bifurcate.What problem did the user have: device failed (e.G.Broke, couldn't get it to work or stopped working).Additional information received on 12/26/2024: the device was implanted and the patient is fine.The device is not available for return.The proximal clasp moved down but did not release the suprarenal fixation.I will attach the imaging i have available along with dr adams case plan.I will have to send those in batches, the file is too large.This was a physician modified device." patient outcome: "the patient is fine.".
Event or Problem Description
"describe the event or problem: during the case, the treo abdominal stent-graft system was stuck on delivery.What was the original intended procedure? fenestrated endovascular repair of visceral and infrarenal aorta percutaneous including four or more visceral artery endoprostheses with bifurcate.What problem did the user have: device failed (e.G.Broke, couldn't get it to work or stopped working).Additional information received on 12/26/2024: the device was implanted and the patient is fine.The device is not available for return.The proximal clasp moved down but did not release the suprarenal fixation.The imaging i have available along with dr.(b)(6) case plan.I will have to send those in batches; the file is too large.This was a physician modified device." patient outcome: "the patient is fine.".
Additional Manufacturer Narrative
Bolton medical, inc.(d/b/a terumo aortic), herein known as the "company", is submitting this report pursuant to 21 cfr part 803, has made reasonable efforts to obtain complete information, and has provided as much as is available to the company as of the submission date of this report.This report is based on information obtained by the company, which may not have been able to fully investigate or verify prior to the date the report was required by the regulations.Any required fields that are unpopulated are blank because the information is currently unknown, unavailable, or not applicable.This report does not constitute an admission or a conclusion by anyone that the device caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the certain regulations, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

• Brand Name: TREO ABDOMINAL STENT-GRAFT SYSTEM
• Common Device Name: STENT, ENDOVASCULAR GRAFT, AORTIC
• Manufacturer (Section D): BOLTON MEDICAL, INC; 799 international parkway; sunrise FL 33325
• Manufacturer Contact: matthew cleary ; 799 international parkway; sunrise, FL 33325 ; 9548389699
• MDR Report Key: 21072079
• Report Number: 2247858-2025-00010
• Device Sequence Number: 3409964
• Product Code: MIH
• UDI-Device Identifier: 00843576152519
• UDI-Public: 00843576152519
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P190015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2025

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 Catalogue Number: 28-B2-26-120U
• Device Lot Number: 2404040069
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2024
• Supplement Date Received by Manufacturer: 10/01/2024
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 05/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/06/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Sex: Male