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

Device Problem Material Invagination (1336)

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

Event Date 03/25/2024

Event Type  malfunction  

Event Description

"unable to deploy: the stent-graft was implanted from the anastomotic portion during tevar after the patient underwent tar and fet.At the timing when the second and third stents were deployed, the distal portion of the second stent and the proximal portion of the third stent were deployed forming the shape of an arch (that is, the stent was deployed by being crushed from the outside to the inside of the aortic bend instead of being deployed cylindrically.) this may be due to the distal portion of the third stent being caught in the endoskeleton of a frozenix (japan lifeline).The proximal portion of the second stent may have been caught as well.The physician noticed that during deployment of the stent-graft and pushed it a little more proximally and pulled it distally, but no improvement was made.Balloon dilatation was then attempted to be performed.A tri-lobe balloon catheter (gore) was used to push the arch from the front and back, but the balloon just collapsed and the shape of the arch did not change.The tri-lobe balloon catheter was then replaced with a coda balloon catheter (cook medical) and the third stent fell in the opposite direction and the final angiography was performed.The procedure was completed as no endoleak was confirmed and there was no problem with blood flow.Operation type: stent graft implantation.Blood loss: unknown.No image available.Pre-case plan available (see the attached schema).Additional information will be able to be obtained.((b)(4))" patient outcome: "no health damage to the patient.".

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
• 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: 19135018
• MDR Text Key: 341157798
• Report Number: 2247858-2024-00099
• 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
• Report Date: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 28-N4-34-209-34U
• Device Lot Number: 2312050426
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/14/2023
• 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): Other; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male