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

Catalog Number 28-N4-32-104-32U

Device Problems Mechanical Problem (1384); Retraction Problem (1536)

Patient Problem Hematoma (1884)

Event Date 05/10/2022

Event Type  malfunction  

Event Description

Pau in descending aorta.During the 3rd step of deployment of the device, the apex release grip would not slide back.The delivery system was then rotated and then the apex release grip did come back, but after the apex release grip came all the way back, it sprang forward.25-.50 inch.Several attempts to keep it back were made, but it kept sliding forward.The delivery system was able to be removed without further incident.Patient outcome - "patient is fine.No actions needed.".

Event Description

Pau in descending aorta.During the 3rd step of deployment of the device, the apex release grip would not slide back.The delivery system was then rotated and then the apex release grip did come back, but after the apex release grip came all the way back, it sprang forward.25-.50 inch.Several attempts to keep it back were made, but it kept sliding forward.The delivery system was able to be removed without further incident.Patient outcome - "patient is fine.No actions needed.".

• Brand Name: RELAY 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: 14418035
• MDR Text Key: 295338725
• Report Number: 2247858-2022-00080
• 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: 07/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/30/2024
• Device Catalogue Number: 28-N4-32-104-32U
• Device Lot Number: 2203240320
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2022
• 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: 74 YR
• Patient Sex: Male