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

Catalog Number 28-N4-32-164-32U

Device Problems Failure to Advance (2524); Malposition of Device (2616); Difficult to Advance (2920)

Patient Problem Perforation (2001)

Event Date 01/29/2024

Event Type  Injury  

Event Description

"dissection: tevar was performed for a descending aortic prosthesis pseudoaneurysm after thoracoabdominal replacement after descending aorta replacement.After insertion of the stent-graft, the access vessel was slightly narrow, but the device went through without problems.An attempt was made to pass the delivery system through a curvature of the descending aorta, but it was too difficult to advance the delivery system.When the inner sheath was advanced in the "1" position, the inner sheath went through the curvature but could not pass through another curvature as the outer sheath lowered.After several attempts, the patient's blood pressure was confirmed to have decreased.After all suspected parts from the ascending aorta were checked by angiography, damage to the iliac artery was finally suspected.The physician had no choice but to implant the stent-graft below the target position.The delivery system was removed and was quickly replaced with a dryseal (gore).Angiography revealed leakage of blood from the iliac artery.Although an excluder (10 x 7, gore) was implanted from the cia, bleeding did not stop.Another excluder (10 x 7, gore) was therefore additionally implanted near the terminal aorta.As the size of the junction did not match, an excluder (12 x 14.5, gore) was then implanted from the same position on the proximal side.The patient's blood pressure finally stabilized.As the proximal end of the excluder was protruding into the ao, a protege gps (12 x 40, medtronic) was implanted from the ao to the cia due to concerns about left leg occlusion.The physician decided to try again once the patient's condition calms down, and the patient returned to the patient's room intubated.Physician's comment: since the aortic prosthesis was anastomosed to the terminal aorta, the cia was clamped.This may have weakened the artery.Operation type: tevar no blood loss: unknown ancillary device used: excluder (10 x 7, gore), excluder (12 x 14.5, gore), protege gps (12 x 40, medtronic) no image available pre-case plan available (see the attached schema) no additional information available ((b)(4))" patient outcome: "health damage to the patient is not serious.The patient's 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: 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: 18793269
• MDR Text Key: 336397549
• Report Number: 2247858-2024-00052
• 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
• Report Date: 02/27/2024

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-N4-32-164-32U
• Device Lot Number: 2208220164
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/29/2024
• Initial Date FDA Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/27/2022
• 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