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

Catalog Number	28-N4-40-154-36U
Medical Device Problem Codes	Material Separation (1562); Separation Problem (4043)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	10/30/2024
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
"the 40/36x754 relay pro nbs was prepped following ifu instructions.The device was put into position in over an 0.35 lunderquist wire in the descending thoracic aorta.Dr.(b)(6) confirmed the delivery system was in position 1 and began turning the deployment grip clockwise.After 2 or 3 turns of the deployment grip, a "crack"/"pop" noise was heard, seeming to come from the controller knob/grey grip area.Dr.(b)(6) announced he heard a "pop" noise.The device appeared to be unaffected visually.Dr.(b)(6) continued to advance the inner sheath out of the outer sheath in normal fashion until the graft was in position.When dr.(b)(6) went to change to position 2 on the control knob, blood was noticed coming out of the delivery system in the advancement indicator area.Dr.(b)(6) deployed the endograft without issue but noticed about 100cc blood loss." patient outcome: "the relay pro nbs 40/36x154 was deployed successfully.The delivery system worked to deployed and remove without issue a unit of blood was ordered for the patient.".
Event or Problem Description
"the 40/36x754 relay pro nbs was prepped following ifu instructions.The device was put into position in over an 0.35 lunderquist wire in the descending thoracic aorta.Dr.(b)(6) confirmed the delivery system was in position 1 and began turning the deployment grip clockwise.After 2 or 3 turns of the deployment grip, a "crack"/"pop" noise was heard, seeming to come from the controller knob/grey grip area.Dr.(b)(6) announced he heard a "pop" noise.The device appeared to be unaffected visually.Dr.(b)(6) continued to advance the inner sheath out of the outer sheath in normal fashion until the graft was in position.When dr.(b)(6) went to change to position 2 on the control knob, blood was noticed coming out of the delivery system in the advancement indicator area.Dr.(b)(6) deployed the endograft without issue but noticed about 100cc blood loss." patient outcome: "the relay pro nbs 40/36x154 was deployed successfully.The delivery system worked to deployed and remove without issue a unit of blood was ordered for the patient.".
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.

• 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: 20735168
• Report Number: 2247858-2024-00299
• Device Sequence Number: 12915112
• Product Code: MIH
• UDI-Device Identifier: 00843576150997
• UDI-Public: 00843576150997
• 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): 03/13/2025

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 Expiration Date: 06/01/2026
• Device Catalogue Number: 28-N4-40-154-36U
• Device Lot Number: 2405230358
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2024
• Supplement Date Received by Manufacturer: 10/30/2024
• Initial Report FDA Received Date: 11/20/2024
• Supplement Report FDA Received Date: 03/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2024
• 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: Other
• Patient Age: 82 YR
• Patient Sex: Female