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

Catalog Number 28-N4-26-104-26U

Device Problems Mechanical Problem (1384); Mechanical Jam (2983)

Patient Problem Failure of Implant (1924)

Event Date 04/28/2022

Event Type  malfunction  

Event Description

Outer sheath broken: before inserting the relay pro device into the patient's body, the orientation of the device was checked.It was found that the position of the d-shaped marker on the inner sheath and the spiral support strut marker were reversed from the original position.Although it was confirmed that the stent-graft was twisted, the physician determined to use the device assuming the s-bar would face toward the greatest curvature of the aorta during advancement as the device length was 100 mm, and inserted the device into the patient's body.The controller was positioned "1", and the deployment grip was rotated to advance the inner sheath.Under fluoroscopy, the inner sheath seemed not being advanced, but the handle could be advanced, the physician assumed that the inner sheath was advanced.Then the controller was turned to the "2" position, and the inner sheath was attempted to be pulled down, but the handle could not be pulled, and the stent-graft could not be deployed.The device was withdrawn and found to be broken at the root of the outer sheath, which resulting in advancement of the broken outer sheath together with the inner sheath.The device was replaced with a new relay pro device of the same size and length, and the procedure was successfully completed.Operation type: tevar in thoracic aortic aneurysm (tc#bm220500020).Patient outcome - "no health damage to the patient.".

Event Description

Outer sheath broken: before inserting the relay pro device into the patient's body, the orientation of the device was checked.It was found that the position of the d-shaped marker on the inner sheath and the spiral support strut marker were reversed from the original position.Although it was confirmed that the stent-graft was twisted, the physician determined to use the device assuming the s-bar would face toward the greatest curvature of the aorta during advancement as the device length was 100 mm, and inserted the device into the patient's body.The controller was positioned "1", and the deployment grip was rotated to advance the inner sheath.Under fluoroscopy, the inner sheath seemed not being advanced, but the handle could be advanced, the physician assumed that the inner sheath was advanced.Then the controller was turned to the "2" position, and the inner sheath was attempted to be pulled down, but the handle could not be pulled, and the stent-graft could not be deployed.The device was withdrawn and found to be broken at the root of the outer sheath, which resulting in advancement of the broken outer sheath together with the inner sheath.The device was replaced with a new relay pro device of the same size and length, and the procedure was successfully completed.Operation type: tevar in thoracic aortic aneurysm.(tc#(b)(4).Patient outcome - "no health damage to the patient.".

• 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: 14414106
• MDR Text Key: 295338756
• Report Number: 2247858-2022-00078
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P200045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/07/2024
• Device Catalogue Number: 28-N4-26-104-26U
• Device Lot Number: 2202010184
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2022
• 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: 99 YR