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

Catalog Number	28-N4-32-164-32U
Medical Device Problem Codes	Difficult to Insert (1316); Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2024
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
"tip of the outer sheath was deformed: treatment was planned via percutaneous approach.Several percloses were put in and then the delivery system was attempted to be inserted into the artery.However, the delivery system encountered resistance and insertion was aborted.Inspection of the delivery system revealed that the tip of the outer sheath was deformed.It was unclear whether the outer sheath was deformed before insertion or during insertion.The delivery system was re-inserted using an introducer sheath (dryseal, gore).Insertion was successful.However, the system was unable to reach the target landing zone.Use of the delivery system was therefore aborted.As the inner sheath was already advanced out of the outer sheath, the procedure was changed to surgical cut-down and the delivery system was removed from the patient together with the dryseal.The procedure was continued using a competitor's stent-graft system (valiant captivia, medronic) and its stent-graft was successfully implanted.Physician's comment: the physician requested us to check if there have been any reports of deformation of the tip of the outer sheath.Operation type: tevar image available no pre-case plan available due to hospital policy additional information will be obtained upon request ancillary devices used: dryseal 22 fr, gore (tc#bm240801206)" patient outcome: "no damage to the patient's health.".
Event or Problem Description
"tip of the outer sheath was deformed: treatment was planned via percutaneous approach.Several percloses were put in and then the delivery system was attempted to be inserted into the artery.However, the delivery system encountered resistance and insertion was aborted.Inspection of the delivery system revealed that the tip of the outer sheath was deformed.It was unclear whether the outer sheath was deformed before insertion or during insertion.The delivery system was re-inserted using an introducer sheath (dryseal, gore).Insertion was successful.However, the system was unable to reach the target landing zone.Use of the delivery system was therefore aborted.As the inner sheath was already advanced out of the outer sheath, the procedure was changed to surgical cut-down and the delivery system was removed from the patient together with the dryseal.The procedure was continued using a competitor's stent-graft system (valiant captivia, medronic) and its stent-graft was successfully implanted.Physician's comment: the physician requested us to check if there have been any reports of deformation of the tip of the outer sheath.Operation type: tevar image available no pre-case plan available due to hospital policy additional information will be obtained upon request ancillary devices used: dryseal 22 fr, gore (tc#(b)(4).Patient outcome: "no damage to the patient's health.".
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, FL 33325 ; 9548389699
• MDR Report Key: 20200025
• Report Number: 2247858-2024-00235
• Device Sequence Number: 7676115
• Product Code: MIH
• UDI-Device Identifier: 00843576150591
• UDI-Public: 00843576150591
• 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: 12/27/2025
• Device Catalogue Number: 28-N4-32-164-32U
• Device Lot Number: 2311280003
• 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: 08/15/2024
• Supplement Date Received by Manufacturer: 08/15/2024
• Initial Report FDA Received Date: 09/12/2024
• Supplement Report FDA Received Date: 02/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/28/2023
• 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