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

Catalog Number 28-NC48N25532S2690

Device Problems Failure to Advance (2524); Difficult to Advance (2920); Failure to Eject (4010)

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

Event Date 03/26/2024

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.Bolton medical is voluntarily reporting an event related to a relay plus custom-made device.The custom made relay plus devices are not marketed in the us, however they are similar to the relay thoracic stent graft with plus delivery system approved for sale in the us (p110038).The event occurred in switzerland.

Event Description

"pt.(b)(6) was prepared for the implant of the branched device; 2 open arterial accesses in the groin; 1 open venous access in the groin for the rapid pacing catheter; 2 open access for the carotid arteries; after that over the right groin a double curved stiff wire was applied, over the left side a pigtail catheter was applied; then the branched device was prepared (the main body was flushed with 6x 20 ml syringes and also the wire lumen was flushed); then the device was brought in over the right groin and advanced to the distal landing zone (device was set on pos 1); then an angiogram was performed; after that dr.(b)(6) started to push out the stent; the tip came out of the outer sheath approximately 2 cm, but the tip capture underneath the tip was detached and the graft stayed in the original position; dr.(b)(6) tried to push a little harder, but nothing happened and he told that he felt a heavy "springly" resistance; because of this we decided not to go further and stopped the implant; the tip was retracted to the outer sheath and the device was removed; outside the body dr.(b)(6) tried again to pull out the graft, but it was the same effect as in the body." patient outcome: "no harm to the patient; the open accesses were closed again.".

• Brand Name: RELAY NBS PLUS (CUSTOM) 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: 19147757
• MDR Text Key: 341463083
• Report Number: 2247858-2024-00098
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P110038
• 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: 04/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 28-NC48N25532S2690
• Device Lot Number: 2402150272
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/06/2024
• 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
• Patient Age: 77 YR
• Patient Sex: Male