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

Catalog Number	28-B2-24-080U
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	07/02/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint was involved with three devices.Device 1 is being reported under mdr-2247858-2024-00321, device 2 is being reported under mdr-2247858-2024-00322, and device 3 is being reported under mdr-2247858-2024-00323.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
"subject (b)(6) had their 3-year follow-up on (b)(6) 2024 where it was noted that he had no changes in health other than new claudication in his left leg.The ct dated (b)(6) 2024 reflected a new complete occlusion of the left iliac limb which was 100% patent on their 2-year imaging dated (b)(6) 2023.The remainder of the device was patent, complete sac regression, and no endoleak.Distal to the stent graft, the left common, external, and internal iliac arteries are patent likely via collaterals.The investigator deemed the event serious for the criteria "permanent impairment of a body structure or body function", and related to the device, specifically iliac leg.The subject stated that the claudication symptoms were not severe enough and denied surgery to correct it at that time.The subject agreed to notify the site if he decided to have his claudication treated in the future." patient outcome: "as of (b)(6) 2024, the subject has not contacted the site nor had any additional follow-ups to discuss plans for re-intervention.".
Additional Manufacturer Narrative
This complaint was involved with three devices.Device 1 is being reported under mdr-2247858-2024-00321, device 2 is being reported under mdr-2247858-2024-00322, and device 3 is being reported under mdr-2247858-2024-00323.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
"subject (b)(6) had their 3-year follow-up on 03jul2024 where it was noted that he had no changes in health other than new claudication in his left leg.The ct dated (b)(6) 2024 reflected a new complete occlusion of the left iliac limb which was 100% patent on their 2-year imaging dated (b)(6) 2023.The remainder of the device was patent, complete sac regression, and no endoleak.Distal to the stent graft, the left common, external, and internal iliac arteries are patent likely via collaterals.The investigator deemed the event serious for the criteria "permanent impairment of a body structure or body function", and related to the device, specifically iliac leg.The subject stated that the claudication symptoms were not severe enough and denied surgery to correct it at that time.The subject agreed to notify the site if he decided to have his claudication treated in the future." patient outcome: "as of november 2024, the subject has not contacted the site nor had any additional follow-ups to discuss plans for re-intervention.".

• 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: 20831430
• Report Number: 2247858-2024-00321
• Device Sequence Number: 8864977
• Product Code: MIH
• UDI-Device Identifier: 08435761052340
• UDI-Public: 08435761052340
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P190015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2025

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 Expiration Date: 02/08/2023
• Device Catalogue Number: 28-B2-24-080U
• Device Lot Number: 2101230199
• 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: 11/13/2024
• Supplement Date Received by Manufacturer: 11/13/2024
• Initial Report FDA Received Date: 12/03/2024
• Supplement Report FDA Received Date: 03/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/08/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 73 YR
• Patient Sex: Male