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

Catalog Number	28-M4-36-145-32U
Medical Device Problem Codes	Difficult to Insert (1316); Difficult to Advance (2920); Material Integrity Problem (2978); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2024
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.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
"broken/defective (black portion at the tip of the outer sheath was found to be turned up): when the delivery system was attempted to be inserted into the femoral artery, the delivery system could not be inserted due to resistance.When the physician checked the tip of the delivery system, the black portion at the tip of the outer sheath was found to be turned up.The physician pressed the black portion at the tip of the outer sheath with his hand to eliminate the deformation and then made a slightly larger cut in the femoral artery, which enabled the delivery system to insert into the artery.When resistance was felt during insertion, the physician did not force the insertion but continued the insertion slowly while checking until the delivery system safely reached the intended position.After that, the stent-graft was implanted, and the procedure was successfully completed.When the removed device was checked, another portion other than the tip pressed by the physician was found to be turned up as well, which was photographed (see the image).As the device had not hit anywhere and there was no place where resistance would be applied during insertion, it was assumed that the portion had already been turned up before use.If the delivery system had been forcibly inserted without being noticed, it could have cut through the inner wall of the artery.The physician is requesting the manufacturer to review and disclose manufacturing and inspection records and report whether or not such an event had occurred so far.Operation type: tevar.Blood loss: 10 ml.Ancillary device used: lunderquist stiff guidewire (cook medical).Image available (see the attached image).Pre-case plan will be able to be obtained.Additional information will be able to be obtained.Delivery system was discarded by user.(tc# (b)(4) ).Patient outcome: no health damage to the patient.".
Event or Problem Description
"broken/defective (black portion at the tip of the outer sheath was found to be turned up): when the delivery system was attempted to be inserted into the femoral artery, the delivery system could not be inserted due to resistance.When the physician checked the tip of the delivery system, the black portion at the tip of the outer sheath was found to be turned up.The physician pressed the black portion at the tip of the outer sheath with his hand to eliminate the deformation and then made a slightly larger cut in the femoral artery, which enabled the delivery system to insert into the artery.When resistance was felt during insertion, the physician did not force the insertion but continued the insertion slowly while checking until the delivery system safely reached the intended position.After that, the stent-graft was implanted, and the procedure was successfully completed.When the removed device was checked, another portion other than the tip pressed by the physician was found to be turned up as well, which was photographed (see the image).As the device had not hit anywhere and there was no place where resistance would be applied during insertion, it was assumed that the portion had already been turned up before use.If the delivery system had been forcibly inserted without being noticed, it could have cut through the inner wall of the artery.The physician is requesting the manufacturer to review and disclose manufacturing and inspection records and report whether or not such an event had occurred so far.Operation type: tevar blood loss: 10 ml ancillary device used: lunderquist stiff guidewire (cook medical) image available (see the attached image) pre-case plan will be able to be obtained additional information will be able to be obtained delivery system was discarded by user (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.

• 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 33325 ; 9548389699
• MDR Report Key: 20514802
• Report Number: 2247858-2024-00266
• Device Sequence Number: 20986804
• Product Code: MIH
• UDI-Device Identifier: 00843576150157
• UDI-Public: 00843576150157
• 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): 02/19/2025

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: 08/01/2026
• Device Catalogue Number: 28-M4-36-145-32U
• Device Lot Number: 2407250056
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2024
• Supplement Date Received by Manufacturer: 09/25/2024
• Initial Report FDA Received Date: 10/23/2024
• Supplement Report FDA Received Date: 02/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2024
• 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 Sex: Unknown