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

Catalog Number	28-N4-42-159-42U
Medical Device Problem Codes	Retraction Problem (1536); Material Deformation (2976); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Cardiac Arrest (1762); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2024
Type of Reportable Event	Death
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
"patient had previous tevar with chronic type b dissection and 7.2 cm aneurysm; he ruptured and was stable at time of implantation.His previous tevar extended to 5 cm proximal to celiac artery; the rupture was at the distal end of the existing graft.We opened n4-42-159-42u ref#(b)(4) and "barebacked it" into the r cia.Device went up with no issue; in the visceral segment we took the flexible inner sheath out of hard outer sheath "in step 1" and placed it in landing zone; we moved to step 2 and dr (b)(6) attempted to turn handle counter clockwise to line up d marker with graft marker.Dr (b)(6) has deployed over 50 relay pros and is a trainer for ta.He complained that the handle kept recoiling back to original position every time he turned it; under fluoro, it was clear that the d marker wasn't moving, and every time he turned the handle, the nose cone would recoil down toward the patients feet.After a few attempts it was clear the graft was getting scrunched with every attempted turn of the handle.We moved the control panel to step 1 in an attempt to recapture the graft (still constrained by inner sheath) and were unable to (even though we have done this before in the past).We were forced to pull the entire device as-is out of the body, resulting in intima coming out with the graft.The patient remained stable and we proceeded with an additional graft.We sealed the aneurysm, closed the patient, and patient was moved from operating room to pacu.Patient coded in pacu and became hypotensive and died." patient outcome: "death approx.1 hr after eventual implant.".
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
"patient had previous tevar with chronic type b dissection and 7.2 cm aneurysm; he ruptured and was stable at time of implantation.His previous tevar extended to 5 cm proximal to celiac artery; the rupture was at the distal end of the existing graft.We opened n4-42-159-42u ref#(b)(4) and "barebacked it" into the r cia.Device went up with no issue; in the visceral segment we took the flexible inner sheath out of hard outer sheath "in step 1" and placed it in landing zone; we moved to step 2 and dr (b)(6) attempted to turn handle counter-clockwise to line up d marker with graft marker.Dr (b)(6) has deployed over 50 relay pros and is a trainer for ta.He complained that the handle kept recoiling back to original position every time he turned it; under fluoro, it was clear that the d marker wasn't moving, and every time he turned the handle, the nose cone would recoil down toward the patients' feet.After a few attempts it was clear the graft was getting scrunched with every attempted turn of the handle.We moved the control panel to step 1 in an attempt to recapture the graft (still constrained by inner sheath) and were unable to (even though we have done this before in the past).We were forced to pull the entire device as-is out of the body, resulting in intima coming out with the graft.The patient remained stable and we proceeded with an additional graft.We sealed the aneurysm, closed the patient, and patient was moved from or to pacu.Patient coded in pacu and became hypotensive and died." patient outcome: "death approx.1 hr after eventual implant.".

• Brand Name: RELAY PRO NBS 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: matthew cleary ; 799 international parkway; sunrise, FL 33325 ; 9548389699
• MDR Report Key: 21054799
• Report Number: 2247858-2025-00005
• Device Sequence Number: 15459612
• Product Code: MIH
• UDI-Device Identifier: 00843576150645
• UDI-Public: 00843576150645
• 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: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2025

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?: Yes
• Device Expiration Date: 02/24/2026
• Device Catalogue Number: 28-N4-42-159-42U
• Device Lot Number: 2402190109
• 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: 12/09/2024
• Supplement Date Received by Manufacturer: 12/09/2024
• Initial Report FDA Received Date: 01/02/2025
• Supplement Report FDA Received Date: 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2024
• 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
• Outcome Attributed to Adverse Event: Death; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male