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

Catalog Number 28-L2-09-120U

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

Event Date 03/04/2024

Event Type  Injury  

Manufacturer Narrative

This complaint was involved with four devices.Device 1 is being reported under mdr 2247858-2024-00086, device 2 is being reported under mdr 2247858-2024-00087, device 3 is being reported under mdr, and device 4 is being reported under mdr 2247858-2024-00089.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.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 Description

"subject (b)(6) had a chest ct on (b)(6) 2024 due to presence of pneumonia (separate event).A non-contrast ct demonstrated an expansion of aneurysm sac to 51mm.A subsequent abd/pelvis ct with contrast performed on (b)(6) 2024 demonstrated an expansion of aneurysm sac to 52mm due to a type ii endoleak at the level of l3.The pi's assessment of the 30-day ct dated (b)(6) 2022 was also 52mm that the measurement has not changed when compared to 30-day follow-up.However, the pi's assessment of the 1-year ct dated (b)(6) 2023 was noted as decreasing to 46mm (also re-confirmed per (b)(6) 2024 ct), therefore there was an decrease of 6mm in approx.9 months after the 1-year follow-up.Subject was admitted on (b)(6) 2024 and underwent a right iliac angioplasty and coil embolization (multiple ruby coils) of lumbar arteries feeding the type ii endoleak same-day with subject discharged on (b)(6) 2024.There were no complications during the procedure.Note: for index procedure the right leg was implanted with 140u and 100u extension patient outcome: "the subject was discharged stable; however the status is currently ongoing and will be re-assessed for resolution once 2-year follow-up with imaging occurs currently scheduled for mid-(b)(6) 2024.".

• 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: 19015338
• MDR Text Key: 339082750
• Report Number: 2247858-2024-00088
• 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: 04/01/2024

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 Catalogue Number: 28-L2-09-120U
• Device Lot Number: 2106080138
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/08/2024
• Initial Date FDA Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/30/2021
• 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): Required Intervention
• Patient Age: 83 YR
• Patient Sex: Female