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

Catalog Number 28-N246209422690S

Device Problems Failure to Advance (2524); Physical Resistance (2578)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/05/2017

Event Type  Injury  

Manufacturer Narrative

During an internal audit, it was determined that complaints for similar devices, and device malfunctions that have the potential to harm the patient if they were to recur, were not reported as per fda guidance.After retrospective review, this event is determined to be mdr reportable.Bolton medical is voluntarily reporting a device malfunction related to a relay nbs plus device.The relay nbs plus device is not marketed in the us, however it is similar to the relay thoracic stent graft with plus delivery system approved for sale in the us in 2012 (p110038).Based on the information available, the exact root cause of the failure mode experienced could not be determined.Therefore, there were not appropriate results and conclusion "event problem and evaluation codes" available - conclusion code was chosen since the investigation results were inconclusive.

Event Description

"during the procedure was a little difficult to advance the delivery system through the aorta, dr.Felt high resistance, dr.Had to apply some strength but finally the system reach the proximal sealing zone that was planned to delivery the relay graft.After that the second delivery system advance also but with less resistance to reach the zone to overlap with the first graft already deployed.Both graft positioning perfectly where was planned previously.At the end of the case dr.Perform a control to check the aorta and the access site, and they saw a radiopaque ring in the right comun iliac, they use a fogarti balloon to take it out".

• Brand Name: RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM
• Type of Device: STENT, ENDOVASCULAR GRAFT, AORTIC
• Manufacturer (Section D): BOLTON MEDICAL, INC.; 799 international parkway; sunrise FL 33325
• Manufacturer Contact: matthew stark ; 799 international parkway; sunrise, FL 33325 ; 8548389699
• MDR Report Key: 7325874
• MDR Text Key: 101961153
• Report Number: 2247858-2018-00080
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 03/08/2018

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 28-N246209422690S
• Device Lot Number: B170110167
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2017
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/05/2017
• Initial Date FDA Received: 03/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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: 55 YR