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

Catalog Number 28-B2-33-100U

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/06/2024

Event Type  malfunction  

Event Description

"delivery system tip broken: evar was performed as per usual procedure.A bilateral leg puncture was performed, and the delivery system of the main bifurcated stent graft was advanced from the left leg.When the delivery system was reached a gentle curve from the external iliac artery to the common iliac artery and continued to advance, the tip of the delivery system separated as shown in the video.To retrieve the separated tip, a dryseal (20fr, gore) was inserted into the left leg, and the delivery system tip was captured with a snare from the left leg.Although the delivery system tip was not fully retracted into the dryseal, the delivery system tip was removed from the body along with the dryseal as it was.Then cutdown was performed on the left leg, and the delivery system of a new treo device (28-b2-33-100u, 2211180375) was introduced with the dryseal inserted to complete the evar.Excluder leg devices (gore) were used for both legs.After the evar was completed, final angiography was performed.There was an endoleak that appeared to be a type 1a, but the physician determined to monitor the patient, and the procedure was completed.Physician's comment: the patient's invasiveness was increased due to cutdown.Operation type: evar.Ancillary devices: excluder leg devices (121400j and 231200j/gore).Image available (attached).Pre-case plan available (schema attached).No additional information available.(tc#(b)(4)).Patient outcome - "there was minor health damage to the patient, and the outcome is unknown.".

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
• 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: 18980610
• MDR Text Key: 338624724
• Report Number: 2247858-2024-00085
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P190015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 28-B2-33-100U
• Device Lot Number: 2211180379
• Initial Date Manufacturer Received: 03/06/2024
• Initial Date FDA Received: 03/26/2024
• 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: 99 YR
• Patient Sex: Female