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

Catalog Number	28-L2-11-100U
Medical Device Problem Code	Device Stenosis (4066)
Health Effect - Clinical Codes	Stenosis (2263); Thrombosis/Thrombus (4440)
Date of Event	08/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint was involved with three devices.Device 1 is being reported under mdr-2247858-2024-00314, and device 3 is being reported under mdr-2247858-2024-00316.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 and recently developed increasing claudication symptoms on the right leg that were debilitating and diagnosed as progressive external iliac occlusive disease.The ct dated (b)(6) 2024 reflected no endoleaks, however per the pi, the ct "indicated the endograft in good position with successful exclusion of aneurysm but there was a high-grade stenosis of the outflow right external iliac artery in its proximal segment.This was felt to be severe and could compromise function in the graft".Additionally, the stenosis "exceeded 80% if not 90%" posing a risk of occlusion with probable thrombosis of the right limb of the graft and severe ischemia.On (b)(6) 2024, the subject underwent outpatient surgery involving an angioplasty with a 7mm balloon and stenting of right external iliac artery using a 12x4 smart stent.There were no complications and the completion angio reflected the right external iliac artery as widely patent with no residual narrowing." patient outcome: "the subject was seen on (b)(6) 2024 and had a us ankle/brachial conducted same-day reflecting an improved abi on the right side and no further significant problems were noted by the subject with her right leg.Subject planned to return in approximately eight months for her next follow-up.".
Event or Problem Description
"(b)(6) had their 3-year follow-up on (b)(6)2024 and recently developed increasing claudication symptoms on the right leg that were debilitating and diagnosed as progressive external iliac occlusive disease.The ct dated (b)(6)2024 reflected no endoleaks, however per the pi, the ct "indicated the endograft in good position with successful exclusion of aneurysm but there was a high-grade stenosis of the outflow right external iliac artery in its proximal segment.This was felt to be severe and could compromise function in the graft".Additionally, the stenosis "exceeded 80% if not 90%" posing a risk of occlusion with probable thrombosis of the right limb of the graft and severe ischemia.On (b)(6)2024, the subject underwent outpatient surgery involving an angioplasty with a 7mm balloon and stenting of right external iliac artery using a 12x4 smart stent.There were no complications and the completion angio reflected the right external iliac artery as widely patent with no residual narrowing." patient outcome: "the subject was seen on (b)(6)2024 and had an ultrasound (us) ankle/brachial conducted same day reflecting an improved ankle brachial index (abi) on the right side and no further significant problems were noted by the subject with her right leg.Subject planned to return in approximately eight months for her next follow-up.".
Additional Manufacturer Narrative
This complaint was involved with three devices.Device 1 is being reported under mdr 2247858-2024-00314, device 2 is being reported under mdr 2247858-2024-00315, and device 3 is being reported under mdr 2247858-2024-00316.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: 20858394
• Report Number: 2247858-2024-00315
• Device Sequence Number: 3864910
• Product Code: MIH
• UDI-Device Identifier: 08435761052050
• UDI-Public: 08435761052050
• 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): 03/27/2025

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: 12/16/2023
• Device Catalogue Number: 28-L2-11-100U
• Device Lot Number: 2012080149
• 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: 11/08/2024
• Supplement Date Received by Manufacturer: 11/08/2024
• Initial Report FDA Received Date: 12/05/2024
• Supplement Report FDA Received Date: 03/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/16/2020
• 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; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female