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

Catalog Number	28-N4-34-209-34U
Medical Device Problem Codes	Ejection Problem (4009); Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
"defective: the relay pro stent-graft concerned and a relay pro stent-graft (28-n4-30-104-30u, lot#2401090104) were used to treat aortic dissection.After the first stent-graft (28-n4-30-104-30u, lot#2401090104) was implanted without any problem, the second stent-graft concerned was deployed with the controller in the "2" position without any problem.However, the apex holder could not be released from the delivery system tip even though the apex holder knob was pulled in the "3" position.Although the apex holder knob was able to be pulled in the "3" position and torque was transmitted to the apex holder, the apex holder was pulled along with the delivery system tip distally and was not release.(at that time, as bail-out technique, the stainless-steel rod was pushed and rotated in the "4" position, and the apex holder knob was pulled in the "3" position while the stainless-steel rod was being pushed in the "4" position.However, the apex holder did not seem to be released.) cut-down technique was therefore used on the contralateral side (left leg) to insert a dry seal sheath (18fr, gore).A balloon catheter was then advanced through the dry seal sheath, and the balloon was inflated near the delivery system tip.The inner catheter was held with a slight change in catheter travel.The controller was then changed to the "4" position by slightly pulling the delivery system, and the stainless-steel rod was pushed proximally, which finally released the apex holder.The procedure time was extended by about 30 minutes due to treatment such as cut-down technique of the left leg and puncture of the right hand to insert a snare catheter.As the final angiography confirmed no endoleak after the apex holder was released, the procedure was successfully completed.Operation type: tevar.Blood loss: unknown.Ancillary device used: 28-n4-30-104-30u (lot# 2401090104).No image available due to hospital policy.No pre-case plan available due to hospital policy.No additional information available due to hospital policy.(tc# (b)(4) )." patient outcome: "no health damage to 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.
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
"defective: the relay pro stent-graft concerned and a relay pro stent-graft (28-n4-30-104-30u, lot#: 2401090104) were used to treat aortic dissection.After the first stent-graft (28-n4-30-104-30u, lot#: 2401090104) was implanted without any problem, the second stent-graft concerned was deployed with the controller in the "2" position without any problem.However, the apex holder could not be released from the delivery system tip even though the apex holder knob was pulled in the "3" position.Although the apex holder knob was able to be pulled in the "3" position and torque was transmitted to the apex holder, the apex holder was pulled along with the delivery system tip distally and was not release.(at that time, as bail-out technique, the stainless-steel rod was pushed and rotated in the "4" position, and the apex holder knob was pulled in the "3" position while the stainless-steel rod was being pushed in the "4" position.However, the apex holder did not seem to be released.) cut-down technique was therefore used on the contralateral side (left leg) to insert a dry seal sheath (18fr, gore).A balloon catheter was then advanced through the dry seal sheath, and the balloon was inflated near the delivery system tip.The inner catheter was held with a slight change in catheter travel.The controller was then changed to the "4" position by slightly pulling the delivery system, and the stainless-steel rod was pushed proximally, which finally released the apex holder.The procedure time was extended by about 30 minutes due to treatment such as cut-down technique of the left leg and puncture of the right hand to insert a snare catheter.As the final angiography confirmed no endoleak after the apex holder was released, the procedure was successfully completed.Operation type: tevar.Blood loss: unknown.Ancillary device used: 28-n4-30-104-30u (lot#: 2401090104).(tc#: (b)(4))." patient outcome: "no health damage to the patient.".

• 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: 20623642
• Report Number: 2247858-2024-00279
• Device Sequence Number: 15658694
• Product Code: MIH
• UDI-Device Identifier: 00843576150737
• UDI-Public: 00843576150737
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 03/26/2025

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: 02/21/2026
• Device Catalogue Number: 28-N4-34-209-34U
• Device Lot Number: 2402130246
• 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: 10/16/2024
• Supplement Date Received by Manufacturer: 10/16/2024
• Initial Report FDA Received Date: 11/06/2024
• Supplement Report FDA Received Date: 03/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2024
• 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 Sex: Unknown