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

Catalog Number 28-N4-30-164-26U

Device Problem Activation Failure (3270)

Patient Problems Ischemia (1942); Unspecified Vascular Problem (4441)

Event Date 09/08/2022

Event Type  malfunction  

Event Description

Relay pro device was opened and prepped as normal.Device was placed through a 20f gore dryseal sheath and advanced to just distal of the distal landing zone.Physician confirmed device was in position 1 and began the turn the black turn handle clockwise in the direction of the white arrow.After a few turns, it was visually confirmed that the device was advancing (i.E., inner sheath coming out of the outer sheath).However, the physician was meeting increasing resistance to turning the black handle to deploy.On flouro it was observed that the inner sheath assembly was only partially deployed out of the outer sheath.Resistance to deploy became so significant that the surgeon was unable to further deploy the device.Upon instruction, the physician tried to advance by pushing the black button and advancing the deployment handle forward, but it would not advance even with significant force.The physician indicated to the ta rep that he thought the device was faulty and wanted it to be taken out.Device was removed from the 20f sheath and case was completed with competitive product.Product was returned as it was when removed from the body with the inner sheath partially deployed from the outer sheath.Patient outcome: "as of this time, no adverse outcome occurred to the patient other than the additional time wasted during attempted deployment.".

Event Description

Relay pro device was opened and prepped as normal.Device was placed through a 20f gore dryseal sheath and advanced to just distal of the distal landing zone.Physician confirmed device was in position 1 and began the turn the black turn handle clockwise in the direction of the white arrow.After a few turns, it was visually confirmed that the device was advancing (ie inner sheath coming out of the outer sheath).However, the physician was meeting increasing resistance to turning the black handle to deploy.On flouro it was observed that the inner sheath assembly was only partially deployed out of the outer sheath.Resistance to deploy became so significant that the surgeon was unable to further deploy the device.Upon instruction, the physician tried to advance by pushing the black button and advancing the deployment handle forward, but it would not advance even with significant force.The physician indicated to the ta rep that he thought the device was faulty and wanted it to be taken out.Device was removed from the 20f sheath and case was completed with competitive product.Product was returned as it was when removed from the body with the inner sheath partially deployed from the outer sheath.Patient outcome - "as of this time, no adverse outcome occurred to the patient other than the additional time wasted during attempted deployment.".

• Brand Name: RELAY NBA 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: 15519594
• MDR Text Key: 306246605
• Report Number: 2247858-2022-00149
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P200045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/01/2023

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 Expiration Date: 03/04/2024
• Device Catalogue Number: 28-N4-30-164-26U
• Device Lot Number: 2202240138
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/08/2022
• Initial Date FDA Received: 09/30/2022
• Supplement Dates Manufacturer Received: 09/08/2022
• Supplement Dates FDA Received: 03/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/05/2022
• 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: 78 YR
• Patient Sex: Female