MAUDE Adverse Event Report: RELAY CUSTOM BRANCH THORACIC STENT-GRAFT SYSTEM; STENT, ENDOVASCULAR GRAFT, AORTIC

Catalog Number 28-NC42N25532S2690

Device Problems Ejection Problem (4009); Difficult or Delayed Separation (4044)

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

Event Date 01/18/2024

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 pro custom-made device.The custom made relay pro devices are not marketed in the us, however they are similar to the relay thoracic stent graft with pro delivery system approved for sale in the us (p200045).The event occurred in spain.

Event Description

"the proximal clasping was not in place.So when advancing the inner sheath que graft got detached from the delivery system.When we advanced the inner sheath at position 1 we saw que conenose advanced but the graft was detached from the delivery.We first thought it has been a problem of excessive force applied but dr.(b)(6) told me he didn't apply such force.Reviewing the procedure film, we realised the proximal clasping had never been correctly attached.You can see it on the picture i took from the film or on the film properly.We have been able to take out the ds with no damage for the patient." patient outcome: "no injuries for the patient.The delivery system was realized without problems.".

• Brand Name: RELAY CUSTOM BRANCH THORACIC STENT-GRAFT SYSTEM
• Type of Device: STENT, ENDOVASCULAR GRAFT, AORTIC
• MDR Report Key: 18717119
• MDR Text Key: 336520975
• Report Number: 2247858-2024-00036
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• PMA/PMN Number: P200045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Type of Report: Initial
• Report Date: 02/15/2024

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-NC42N25532S2690
• Device Lot Number: 2311010473
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/18/2024
• Initial Date FDA Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/15/2023
• 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
• Patient Age: 73 YR
• Patient Sex: Male