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

Catalog Number 28-N4-38-154-34U

Device Problems Failure to Align (2522); Activation, Positioning or Separation Problem (2906)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/28/2023

Event Type  malfunction  

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

"broken/defective: a relaypro stent-graft (28-n4-38-199-34u) was deployed without problems.The procedure was planned to be completed with one stent-graft, but the relaypro stent-graft (28-n4-38-154-34u) concerned was added to the proximal side as the length was not long enough to cover the lesion.The second stent-graft was deployed so that two stents protruded from the first stent-graft implanted.Although there was no problem with the deployment, when the delivery system tip was attempted to be rejoined the outer sheath by placing the controller in position 4, resistance was felt when the delivery system tip was inserted into the outer sheath.The delivery system was then removed from the patient.When the tip of the delivery system was checked, it was found that the tip of the outer sheath was twisted inward and the rear part of the delivery system tip was twisted outward, which was not seated accurately.When the access artery was checked, no damage was noted.The procedure was successfully completed.Operation type: tevar for descending thoracic aortic aneurysm.No blood loss.Ancillary device used: 28-n4-38-199-34u.Image available.Pre-case plan available (see the attached image).No additional information available.(tc#(b)(4))".Patient outcome - "no health damage to the patient.".

Event Description

"broken/defective: a relaypro stent-graft (28-n4-38-199-34u) was deployed without problems.The procedure was planned to be completed with one stent-graft, but the relaypro stent-graft (28-n4-38-154-34u) concerned was added to the proximal side as the length was not long enough to cover the lesion.The second stent-graft was deployed so that two stents protruded from the first stent-graft implanted.Although there was no problem with the deployment, when the delivery system tip was attempted to be rejoined the outer sheath by placing the controller in position 4, resistance was felt when the delivery system tip was inserted into the outer sheath.The delivery system was then removed from the patient.When the tip of the delivery system was checked, it was found that the tip of the outer sheath was twisted inward and the rear part of the delivery system tip was twisted outward, which was not seated accurately.When the access artery was checked, no damage was noted.The procedure was successfully completed.Operation type: tevar for descending thoracic aortic aneurysm no blood loss ancillary device used: (b)(6).Image available (see the attached 3 images, no other images available) pre-case plan available (see the attached image) no additional information available (tc#(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 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: 17769850
• MDR Text Key: 324155325
• Report Number: 2247858-2023-00245
• 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: 10/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 28-N4-38-154-34U
• Device Lot Number: 2209030044
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2022
• 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 Age: 99 YR