MAUDE Adverse Event Report: BOLTON MEDICAL, INC. RELAY PRO NBS THORACIC STENT-GRAFT SYSTEM; STENT, ENDOVASCULAR GRAFT, AORTIC

Catalog Number 28-N4-28-164-24U

Device Problems Positioning Failure (1158); Malposition of Device (2616); Patient Device Interaction Problem (4001)

Patient Problem Obstruction/Occlusion (2422)

Event Date 11/22/2023

Event Type  Injury  

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.

Event Description

"failure due to the technique: tevar was performed to close an entry tear of acute aortic dissection with complications.As the main entry tear was located near the celiac artery, the stent graft was planned to be placed proximal to the sma.However, when the relay pro stent graft was attempted to be deployed proximal to the sma, the pressure of the blood flow caused the stent graft to flow distally and cover the sma.(as the device was implanted at a different site from the intended site, the lesser curvature of the vessel became sharpened from the gentle curve of the patient's original vessel.) an attempt was made to cannulate the sma, but cannulation was unsuccessful.The procedure was converted to open surgery.Vein graft was harvested from the femoral vein and bypass surgery to the sma and the external iliac artery was performed.The procedure was successfully completed with confirmation of blood flow to the bypass on final angiogram.Operation type: tevar blood loss: amount is unknown.No image available no pre-case plan available no additional information will be obtained.(tc#bm 231103221)" patient outcome: "damage to the patient's health 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.

Event Description

"failure due to the technique: tevar was performed to close an entry tear of acute aortic dissection with complications.As the main entry tear was located near the celiac artery, the stent graft was planned to be placed proximal to the sma.However, when the relay pro stent graft was attempted to be deployed proximal to the sma, the pressure of the blood flow caused the stent graft to flow distally and cover the sma.(as the device was implanted at a different site from the intended site, the lesser curvature of the vessel became sharpened from the gentle curve of the patient's original vessel.) an attempt was made to cannulate the sma, but cannulation was unsuccessful.The procedure was converted to open surgery.Vein graft was harvested from the femoral vein and bypass surgery to the sma and the external iliac artery was performed.The procedure was successfully completed with confirmation of blood flow to the bypass on final angiogram.Operation type: tevar.Blood loss: amount is unknown.No image available.No pre-case plan available.No additional information will be obtained.(tc#: (b)(4)." patient outcome: "damage to the patient's health is unknown.".

• Brand Name: RELAY PRO NBS THORACIC 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: 18371243
• MDR Text Key: 331082629
• Report Number: 2247858-2023-00333
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P200045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/31/2024

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-N4-28-164-24U
• Device Lot Number: 2209300114
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/22/2023
• Initial Date FDA Received: 12/21/2023
• Supplement Dates Manufacturer Received: 11/22/2023
• Supplement Dates FDA Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2022
• 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