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

Catalog Number 28-N4-34-109-34U

Device Problem Positioning Problem (3009)

Patient Problems Hemorrhage/Bleeding (1888); Laceration(s) (1946); Perforation of Vessels (2135)

Event Date 12/22/2023

Event Type  Injury  

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

"vessel injury/ bleeding: the target lesion was a saccular aneurysm just above the celiac artery.As the peripheral landing length of the relaypro device was insufficient against the specified length, coiling was performed in the celiac artery, and a viabahn (gore) was inserted after cannulation of the sma.The peripheral landing length was secured using the chimney technique, and the tevar was successfully completed without endoleak.After the procedure, the patient complained of abdominal pain and blood pressure dropped after awakening from anesthesia.The patient was reanesthetized and found that the peripheral part of the sma was injured and the contrast medium was leaking into the abdominal cavity.A radiologist attempted to achieve hemostasis with a coil, but the abdomen swelled up and the patient had to undergo surgical treatment.The treatment was successfully completed.The physician commented that there was no problem with the relaypro device itself, and that the cause of the event was that the guidewire was inserted too deeply when cannulating the sma.No further information is available.Operation type: tevar.Blood loss: amount is unknown.No image available.No additional pre-case plan available (schema attached).No additional information available.(tc#(b)(4))" patient outcome: "the patient's outcome is unknown.".

• 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: 18546573
• MDR Text Key: 333315373
• Report Number: 2247858-2024-00011
• 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: 01/19/2024

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-N4-34-109-34U
• Device Lot Number: 2301120036
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/21/2023
• Initial Date FDA Received: 01/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2023
• 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): Required Intervention