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

Catalog Number 28-C2-33-040U

Device Problems Fluid/Blood Leak (1250); Failure to Seal (4070)

Event Date 02/26/2024

Event Type  Injury  

Event Description

"an update email was received on 03/14/2024 from (b)(6), senior clinical research associate, to correct dates and information previously submitted.*1-year timepoint event: subject (b)(6)'s 1-year ct on (b)(6) 2022 reflected a type ii persistent endoleak from the ima causing growth to the native aneurysm.The pi's assessment of the 30-day ct dated (b)(6) 2021 measured at 61mm as compared to the 1-year ct which measured at 66mm.As a result, the subject underwent an embolization of the ima on (b)(6) 2022 using two terumo azure peripheral coils.The post-procedure angio showed occlusion of the ima.**2-year timepoint event: the subject's 2-year ct on (b)(6) 2023 reflected a >5mm increase in aneurysm of 72mm as confirmed by the pi.This was an 11mm increase as compared to the 30-day follow-up.".Patient outcome - "pending further information from the site.".

Manufacturer Narrative

This complaint was involved with four devices.Device 1 is being reported under mdr 2247858-2024-00077, device 2 is being reported under mdr 2247858-2024-00078, device 3 is being reported under mdr 2247858-2024-00079, and device 4 is being reported under mdr 2247858-2024-00080.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
• 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: 18978100
• MDR Text Key: 338591244
• Report Number: 2247858-2024-00078
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P190015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/15/2022
• Device Catalogue Number: 28-C2-33-040U
• Device Lot Number: 2010260090
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/15/2020
• 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
• Patient Age: 82 YR
• Patient Sex: Male