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

Catalog Number	28-M4-30-250-30U
Medical Device Problem Codes	Failure to Advance (2524); Difficult to Advance (2920)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	08/22/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
"unable to advance the inner sheath/bleeding: the relaypro was inserted from the right femoral artery for tevar and advanced to the implantation site.The inner sheath was advanced centrally with the controller in position 1, but advancement of the inner sheath was slow and did not fully come out of the outer sheath.Therefore, the relaypro was withdrawn and removed from the patient.Another relaypro device of different specifications was used to continue the procedure, and the procedure was successfully completed.When the relaypro was being withdrawn, the intima near the right femoral artery was slightly peeled off.Angiography was performed to check for damage and the physician determined that it was minor, but a lifestream covered stent (becton, dickinson and company) was implanted in the damaged area for safety.Physician's comment: blood loss was approximately 100~200ml during the procedure.It was good that the relaypro was safely removed, and the patient was not affected too much.We would like you to clarify the cause of why such an event occurred.Operation type: tevar blood loss: approximately 100~200ml ancillary device: egoist stiff guidewire (medico's hirata) image available upon request pre-case plan available upon request no additional information available due to hospital policy (tc#bm240801805)" patient outcome: "there was minor health damage to the patient.The patient recovered.".
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 have not 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.
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
"unable to advance the inner sheath/bleeding: the relaypro was inserted from the right femoral artery for tevar and advanced to the implantation site.The inner sheath was advanced centrally with the controller in position 1, but advancement of the inner sheath was slow and did not fully come out of the outer sheath.Therefore, the relaypro was withdrawn and removed from the patient.Another relaypro device of different specifications was used to continue the procedure, and the procedure was successfully completed.When the relaypro was being withdrawn, the intima near the right femoral artery was slightly peeled off.Angiography was performed to check for damage and the physician determined that it was minor, but a lifestream covered stent (becton, dickinson and company) was implanted in the damaged area for safety.Physician's comment: blood loss was approximately 100~200ml during the procedure.It was good that the relaypro was safely removed, and the patient was not affected too much.We would like you to clarify the cause of why such an event occurred.Operation type: tevar blood loss: approximately 100~200ml ancillary device: egoist stiff guidewire (medico's hirata) image available upon request pre-case plan available upon request no additional information available due to hospital policy (tc#bm240801805)" patient outcome: "there was minor health damage to the patient.The patient recovered.".

• 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: matthew cleary ; 799 international parkway; sunrise, fl, FL 33325 ; 9548389699
• MDR Report Key: 20249121
• Report Number: 2247858-2024-00239
• Device Sequence Number: 12571571
• Product Code: MIH
• UDI-Device Identifier: 00843576150027
• UDI-Public: 00843576150027
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P200045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 02/12/2025

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: 10/18/2025
• Device Catalogue Number: 28-M4-30-250-30U
• Device Lot Number: 2310120329
• 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: 08/22/2024
• Supplement Date Received by Manufacturer: 08/22/2024
• Initial Report FDA Received Date: 09/18/2024
• Supplement Report FDA Received Date: 02/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2023
• 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: Required Intervention; Other
• Patient Sex: Unknown