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

Catalog Number 28-N4-46-209-46U

Device Problem Material Invagination (1336)

Patient Problems Stenosis (2263); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/15/2023

Event Type  malfunction  

Event Description

"unable to fully deploy the stent-graft: the peripheral relay pro stent-graft (28-n4-40-154-36u) was first deployed from 3 cm proximal to the celiac artery and successfully implanted.The relay pro stent-graft concerned was then deployed from zone 4 and placed proximally to the first stent-graft.Final angiogram revealed that the proximal relay pro stent-graft was deformed and had not expanded to the intended diameter.Careful balloon modeling did not improve the situation.A cone-beam ct scan confirmed that infolding had occurred in the proximal two stents.As no blood flow into the aneurysm was observed, the procedure was completed.Physician's comment.A large device was implanted in a narrow portion of the blood vessel, resulting in infolding.Operation type: tevar blood loss: unknown.No image available no pre-case plan available additional information may be obtained upon request tc (b)(4)" patient outcome: "no damage to the patient's health.".

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.

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 Description

"unable to fully deploy the stent-graft: the peripheral relay pro stent-graft (28-n4-40-154-36u) was first deployed from 3 cm proximal to the celiac artery and successfully implanted.The relay pro stent-graft concerned was then deployed from zone 4 and placed proximally to the first stent-graft.Final angiogram revealed that the proximal relay pro stent-graft was deformed and had not expanded to the intended diameter.Careful balloon modeling did not improve the situation.A cone-beam ct scan confirmed that infolding had occurred in the proximal two stents.As no blood flow into the aneurysm was observed, the procedure was completed.Physician's comment.A large device was implanted in a narrow portion of the blood vessel, resulting in infolding.Operation type: tevar.Blood loss: unknown.No image available.No pre-case plan available.Additional information may be obtained upon request (tc#(b)(4))".Patient outcome: "no damage to the patient's health.".

• Brand Name: RELAY PRO NBS THORACIC STENT-GRAFT SYSTEM
• Type of Device: STENT, ENDOVASCULAR GRAFT, AORTIC
• Manufacturer (Section D): BOLTON MEDICAL, INC.; 799 international parkway; sunrise FL 33325
• Manufacturer Contact: megan indeglia ; 799 international parkway; sunrise, FL 33325 ; 9548389699
• MDR Report Key: 18508052
• MDR Text Key: 333348463
• Report Number: 2247858-2024-00005
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P200045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/09/2024
• Device Catalogue Number: 28-N4-46-209-46U
• Device Lot Number: 2202010188
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention