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

Catalog Number 28-N4-36-154-36U

Device Problem Premature Activation (1484)

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

Event Date 08/16/2022

Event Type  malfunction  

Event Description

The 36x150 nbs started to deploy as it was being advanced out of the primary sheath and to our desired implant location.The secondary sheath was pinned against the wire and a previously placed elephant trunk.We immediately stopped advancing the graft and put it into position 2.The device was then successfully implanted in patient.A proximal extension was then placed proximally to our initial desired landing spot.The patient had no leaks or issues after successful graft deployments.Patient outcome - "patient was fine and did well.".

Event Description

The 36x150 nbs started to deploy as it was being advanced out of the primary sheath and to our desired implant location.The secondary sheath was pinned against the wire and a previously placed elephant trunk.We immediately stopped advancing the graft and put it into position 2.The device was then successfully implanted in patient.A proximal extension was then placed proximally to our initial desired landing spot.The patient had no leaks or issues after successful graft deployments.Patient outcome - "patient was fine and did well.".

• 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 ; 9548389699
• MDR Report Key: 15300847
• MDR Text Key: 303310036
• Report Number: 2247858-2022-00132
• 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: 01/06/2023

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: 11/25/2023
• Device Catalogue Number: 28-N4-36-154-36U
• Device Lot Number: 2111180074
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/19/2022
• Initial Date FDA Received: 08/26/2022
• Supplement Dates Manufacturer Received: 08/19/2022
• Supplement Dates FDA Received: 01/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2021
• 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: 71 YR
• Patient Sex: Male