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

Catalog Number 28-N4-40-204-36U

Device Problems Premature Activation (1484); Obstruction of Flow (2423); Malposition of Device (2616); Premature Separation (4045)

Patient Problem Obstruction/Occlusion (2422)

Event Date 12/26/2023

Event Type  Injury  

Event Description

"treatment of a 37 mm diameter aortic arch aneurysm just below the brachiocephalic artery was planned to place the relay pro nbs (40 mm) in zone 1 and a najuta (42 mm) in zone 0 with two debranchings.The delivery system of the relay pro was inserted via the 24fr dryseal accessed through the left femoral artery, and then, from the aortic valve level, the inner sheath was advanced to 5th stent by rotating the deployment grip, and the remaining portion of the inner sheath was advanced by advancing deployment grip.When the deployment grip reached the arrow marker on the main handle body, it was found that the proximal tip of the stent-graft was released and the first stent was deployed unintentionally.As the tip of the stent-graft was located proximal to the brachiocephalic artery, position adjustment was made to align the proximal marker just below the brachiocephalic artery, and then the controller was placed in the "2" position to deploy the stent-graft.As a result, the proximal portion of the stent-graft was deployed in a position that nearly occluded the brachiocephalic artery and blood flow in the brachiocephalic artery region was lost.After implanting the najuta stent-graft, the stent (epic 10mm - 60 mm) was placed from the brachiocephalic artery and blood flow was secured.Physician's comment: the physician usually ensures that no forward or backward force associated with delivery system insertion is applied to the delivery system when deploying the stent-graft.However, in this procedure, since the stent-graft unintentionally began to deploy outside the target zone though the controller was placed in the "1" position, deployment had to be performed with applying forces to adjust position of the delivery system so as to prevent the stent-graft from being deployed in an unintended site.The physician would like a response as to why the tip of the stent-graft deployed unintentionally during the inner sheath advancement.The physician also commented it is likely that there is a relationship between the use of the device and the event occurred.Operation type: two debranching tevar for aortic arch aneurysm blood loss: none images available upon request pre-case plan available upon request additional information available upon request ancillary devices used: stent-graft: najuta s42s3hnn, sb-kawasumi stent: epic 10 mm - 60 mm, boston scientific balloon catheter: ultraverse 10 mm - 40 mm, bd (tc#bm231203658)." patient outcome: "the patient was in serious condition but has recovered.".

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.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

"treatment of a 37 mm diameter aortic arch aneurysm just below the brachiocephalic artery was planned to place the relay pro nbs (40 mm) in zone 1 and a najuta (42 mm) in zone 0 with two debranchings.The delivery system of the relay pro was inserted via the 24fr dryseal accessed through the left femoral artery, and then, from the aortic valve level, the inner sheath was advanced to 5th stent by rotating the deployment grip, and the remaining portion of the inner sheath was advanced by advancing deployment grip.When the deployment grip reached the arrow marker on the main handle body, it was found that the proximal tip of the stent-graft was released and the first stent was deployed unintentionally.As the tip of the stent-graft was located proximal to the brachiocephalic artery, position adjustment was made to align the proximal marker just below the brachiocephalic artery, and then the controller was placed in the "2" position to deploy the stent-graft.As a result, the proximal portion of the stent-graft was deployed in a position that nearly occluded the brachiocephalic artery and blood flow in the brachiocephalic artery region was lost.After implanting the najuta stent-graft, the stent (epic 10mm - 60 mm) was placed from the brachiocephalic artery and blood flow was secured.Physician's comment: the physician usually ensures that no forward or backward force associated with delivery system insertion is applied to the delivery system when deploying the stent-graft.However, in this procedure, since the stent-graft unintentionally began to deploy outside the target zone though the controller was placed in the "1" position, deployment had to be performed with applying forces to adjust position of the delivery system so as to prevent the stent-graft from being deployed in an unintended site.The physician would like a response as to why the tip of the stent-graft deployed unintentionally during the inner sheath advancement.The physician also commented it is likely that there is a relationship between the use of the device and the event occurred.Operation type: two debranching tevar for aortic arch aneurysm blood loss: none.Images available upon request.Pre-case plan available upon request.Additional information available upon request.Ancillary devices used: stent-graft: najuta s42s3hnn, sb-kawasumi.Stent: epic 10 mm - 60 mm, boston scientific.Balloon catheter: ultraverse 10 mm - 40 mm, bd.(b)(6).Additional information obtained 01/22/2024: in the video, when the inner sheath is advanced and reaches the arch, it appears that the d marker on the inner sheath is fixed (just at the location of calcification on the ct image) and that the inner sheath becomes stuck.Is it possible that the inner sheath was attempted to be advanced further with the d-marker on the inner sheath being fixed at this position resulted in the deployment of the tip? we would like to know bolton's view on this.(01/23/24)" patient outcome: "the patient was in serious condition but has recovered.".

• 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: 18575468
• MDR Text Key: 333661751
• Report Number: 2247858-2024-00013
• 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: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 28-N4-40-204-36U
• Device Lot Number: 2209080003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/26/2023
• Initial Date FDA Received: 01/24/2024
• Supplement Dates Manufacturer Received: 12/26/2023
• Supplement Dates FDA Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/13/2022
• 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
• Patient Age: 79 YR
• Patient Sex: Male