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

Catalog Number 28-N4-42-204-42U

Device Problem Fluid/Blood Leak (1250)

Patient Problem Pleural Effusion (2010)

Event Date 11/25/2022

Event Type  Injury  

Event Description

Endoleak (type iiia, suspected).The patient underwent the procedure on (b)(6) 2022.Two relay pro stents were used in this case, but the overlap was insufficient from the planning stage.(the overlap should have been for 3 stent rings, but it was only for 1 stent ring.) therefore, a zenith alpha distal extension (cook medical) was added to the connecting part of the stents.The procedure was completed with no endleak during the procedure.On (b)(6), a postoperative ct examination was performed.The patient complained of pain after the ct examination and was taken to the icu.The ct scan showed that there appeared to be a slight flow of contrast medium between the relay pro and the zenith alpha distal extension.As an impending aortic rupture was suspected due to type iiia endoleak, an emergency procedure was performed, and an additional relay pro (28-n4-42-204-42u) was implanted.During the procedure, angiography showed no endleak, and the procedure was completed successfully.According to the physician, although type iiia endoleak was suspected, the patient also had a pleural effusion, and the pressure caused by the effusion was considered a possible cause.Since both relay pro and zenith alpha distal extension are being used, it is unclear which caused the endleak.The patient is scheduled to have drainage to drain the pleural effusion after this procedure on 25th.Ancillary devices: relay pro(28-n4-38-199-34u, 2209060193), zenith alpha distal extension (zta-de-46-97-w1, cook medical).Operation type: tevar.(tc# :bm221102670).Patient outcome - "the patient was in serious condition, and the outcome after the procedure is unknown.".

Event Description

Endoleak (type iiia, suspected) the patient underwent the procedure on (b)(6), 2022.Two relay pro stents were used in this case, but the overlap was insufficient from the planning stage.(the overlap should have been for 3 stent rings, but it was only for 1 stent ring.) therefore, a zenith alpha distal extension (cook medical)) was added to the connecting part of the stents.The procedure was completed with no endleak during the procedure.On (b)(6), a postoperative ct examination was performed.The patient complained of pain after the ct examination and was taken to the icu.The ct scan showed that there appeared to be a slight flow of contrast medium between the relay pro and the zenith alpha distal extension.As an impending aortic rupture was suspected due to type iiia endoleak, an emergency procedure was performed, and an additional relay pro (b)(6) was implanted.During the procedure, angiography showed no endleak, and the procedure was completed successfully.According to the physician, although type iiia endoleak was suspected, the patient also had a pleural effusion, and the pressure caused by the effusion was considered a possible cause.Since both relay pro and zenith alpha distal extension are being used, it is unclear which caused the endleak.The patient is scheduled to have drainage to drain the pleural effusion after this procedure on (b)(6).Ancillary devices: relay pro (b)(6) zenith alpha distal extension ((b)(6), cook medical) operation type: tevar (tc# (b)(6) patient outcome - "the patient was in serious condition, and the outcome after the procedure is unknown.".

• 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: 16016912
• MDR Text Key: 305836875
• Report Number: 2247858-2022-00200
• 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: 02/03/2023

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: 10/07/2023
• Device Catalogue Number: 28-N4-42-204-42U
• Device Lot Number: 2107260414
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/28/2022
• Initial Date FDA Received: 12/20/2022
• Supplement Dates Manufacturer Received: 11/28/2022
• Supplement Dates FDA Received: 02/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2021
• 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 Outcome(s): Other
• Patient Age: 99 YR