MAUDE Adverse Event Report: BOLTON MEDICAL, INC. RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM; STENT, ENDOVASCUALR GRAFT, AORTIC

Catalog Number 28-M334200342490U

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fever (1858); Unspecified Infection (1930); Patient Problem/Medical Problem (2688)

Event Date 01/31/2020

Event Type  Injury  

Event Description

"suspicion of infection and distal sine: in 2019 (date unknown), aortic arch replacement and tevar (c-tag) were performed because immediate treatment was necessary.At that time, an aneurysm remaining in the descending aorta was left untreated.Later on, on (b)(6) 2019, additional tevar was performed for the descending aortic aneurysm using the relay plus device.The aneurysm was excluded and the procedure was completed.On (b)(6) 2020, the patient visited the hospital because of a fever.After a ct examination, infection and distal sine on the lesser curvature side were suspected and the patient underwent thoracic surgery.The implanted c-tag and the relay plus device were withdrawn, and the thoracic cavity was washed, and then tevar was performed by using blood vessel prosthesis implantation.The cause of the infection is unknown.As infection was suspected, all the stent grafts were withdrawn and successfully removed.Since it was impossible to withdraw the aortic arch one in the visual field, it was cut as much as possible and then tevar was performed." patient outcome: "there was a serious health damage, but the patient's current condition is favorable.".

Event Description

"suspicion of infection and distal sine: in 2019 (date unknown), aortic arch replacement and tevar (c-tag) were performed because immediate treatment was necessary.At that time, an aneurysm remaining in the descending aorta was left untreated.Later on, on (b)(6) 2019, additional tevar was performed for the descending aortic aneurysm using the relay plus device.The aneurysm was excluded and the procedure was completed.On (b)(6) 2020, the patient visited the hospital because of a fever.After a ct examination, infection and distal sine on the lesser curvature side were suspected and the patient underwent thoracic surgery.The implanted c-tag and the relay plus device were withdrawn, and the thoracic cavity was washed, and then tevar was performed by using blood vessel prosthesis implantation.The cause of the infection is unknown.As infection was suspected, all the stent grafts were withdrawn and successfully removed.Since it was impossible to withdraw the aortic arch one in the visual field, it was cut as much as possible and then tevar was performed." patient outcome: "there was a serious health damage, but the patient's current condition is favorable.".

• Brand Name: RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM
• Type of Device: STENT, ENDOVASCUALR GRAFT, AORTIC
• Manufacturer (Section D): BOLTON MEDICAL, INC.; 799 international parkway; sunrise, fl
• MDR Report Key: 9764950
• MDR Text Key: 181220157
• Report Number: 2247858-2020-00007
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• PMA/PMN Number: P110038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 04/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/02/2023
• Device Catalogue Number: 28-M334200342490U
• Device Lot Number: 190125181
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/03/2020
• Initial Date FDA Received: 02/27/2020
• Supplement Dates Manufacturer Received: 02/03/2020
• Supplement Dates FDA Received: 04/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention