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

Catalog Number 28-N4-34-154-34U

Device Problem Premature Activation (1484)

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

Event Date 01/24/2023

Event Type  malfunction  

Event Description

First delivery system (catalog # 28-n4-36-199-32u, lot # 2207280156) could not be advanced into a very tight arch due to a small true lumen.Device was removed from the patient.Second delivery system (catalog # 28-n4-34-154-34u, lot # 2108140081) was then chosen due to smaller size.In position 1, as we were moving the graft up and around the very tight arch in the small true lumen and into the surgical graft, the graft started to auto deploy the top stent.We then went to step 2 and deployed the rest of the graft.Patient outcome - "patient is doing fine.".

Event Description

First delivery system (catalog # 28-n4-36-199-32u, lot # 2207280156) could not be advanced into a very tight arch due to a small true lumen.Device was removed from the patient.Second delivery system (catalog # 28-n4-34-154-34u, lot # 2108140081) was then chosen due to smaller size.In position 1, as we were moving the graft up and around the very tight arch in the small true lumen and into the surgical graft, the graft started to auto deploy the top stent.We then went to step 2 and deployed the rest of the graft.Patient outcome - "patient is doing fine.".

• Brand Name: RELAY NBS 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 ; 9548339699
• MDR Report Key: 16416537
• MDR Text Key: 310048176
• Report Number: 2247858-2023-00048
• 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: 04/24/2023

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: 09/30/2023
• Device Catalogue Number: 28-N4-34-154-34U
• Device Lot Number: 2108140081
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/24/2023
• Initial Date FDA Received: 02/22/2023
• Supplement Dates Manufacturer Received: 01/24/2023
• Supplement Dates FDA Received: 04/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2021
• 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: 62 YR
• Patient Sex: Female