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

Catalog Number	28-M4-30-200-30U
Medical Device Problem Codes	Mechanical Problem (1384); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2025
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
"a 30x200mm relay pro bare stent was introduced through the patients right common "femoral" "artery".The device was positioned in the "appropriate" location of the "descending" aorta proximal to the celiac artery.The physician "verified" the device was in position 1 on the controller and began to roll the black deployment grip clockwise (away from him) to advance the inner sheath into the appropriate position.The inner sheath did not respond and remained in the primary sheath.The physician then pressed the black disengagement button and advanced the inner sheath manually.When the proximal end of the inner sheath was in position, distal to the lsa, we noticed that there was still one stent remaining in the proximal sheath.However, the disengagement button was moved all the way forward meeting the controller and could not be "advanced" any farther.The physician tried rolling the deployment grip again and still no response from the inner sheath.We called several associates in the field as well as engineering for some bail outs and work arounds.In the end, the physician was able to "accordion, train-wreck", the primary sheath on itself by having the fellow push the device forward, while he simultaneously pushed the primary sheath back.This allowed the last stent on the distal end of the graft to become free from the primary sheath.At this point we felt safe to finish deployment.The rest of the deployment went normal and graft was implanted and case completed." patient outcome: "patient was taken to icu after case per policy.As of this morning (b)(6) 2025 the patient is doing ok and scheduled for release either today or tomorrow.".

• Brand Name: RELAY PRO THORACIC STENT-GRAFT SYSTEM
• Common Device Name: STENT, ENDOVASCULAR GRAFT, AORTIC
• Manufacturer (Section D): BOLTON MEDICAL, INC.; 799 international parkway; sunrise FL 33325
• Manufacturer Contact: manuel benitez ; 799 international parkway; sunrise, FL 33325 ; 9548389699
• MDR Report Key: 23368116
• Report Number: 2247858-2025-00247
• Device Sequence Number: 21111746
• Product Code: MIH
• UDI-Device Identifier: 00843576149892
• UDI-Public: 00843576149892
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P200045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2026

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 Catalogue Number: 28-M4-30-200-30U
• Device Lot Number: 2506160304
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2025
• Supplement Date Received by Manufacturer: 05/20/2026
• Initial Report FDA Received Date: 10/23/2025
• Supplement Report FDA Received Date: 06/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/03/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 87 YR
• Patient Sex: Female