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

Catalog Number 28-N4-28-104-28X

Device Problem Material Invagination (1336)

Patient Problems Pleural Effusion (2010); Ascites (2596); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/03/2018

Event Type  Injury  

Event Description

Report from the physician stated, "we then turned our attention to the endovascular portion of the procedure a 6 french dry seal sheath was then placed.Angiography of the aortic arch was performed following which we deployed a 28 x 104 mm relay pro nbs device.We landed it midway between the subclavian artery and common carotid artery origins in order to allow for the length of the device to reach beyond the anticipated distal seal zone.However, during deployment the device seemed to shorten as it followed the aneurysmal segment of the abnormality and because of that there was only marginal distal seal and the type lb endoleak was noted.We therefore extended distally using a 30 x 104 mm (28-n4-30-104-30x, lot # 171108169) relay pro nbs device.Injection revealed good positioning and no evidence of endoleak.There was noted kinking between the first and second stent units of the device but with maintained brisk flow across the area of angulation." on (b)(6) 2018, the subject underwent a follow-up ct angiogram of the chest and was found to have an endoleak, likely type i in the proximal descending thoracic aorta at the junction of the two stent grafts.In addition, the scan showed a new small bilateral pleural effusion and upper abdominal ascites.Patient outcome - "on (b)(6) 2018, the decision was made to undergo secondary intervention for the endoleak with kinking.Revision of the thoracic aneurysm with extension of the endovascular graft was performed via access of the right femoral artery, a 28×100 mm relay pro was introduced and deployed flush with the origin of the left common carotid artery while ensuring sufficient overlap with the existing stent graft.The stent graft followed the acute kink present at the apex of the aortic curvature and the area was dilated with a coda balloon to iron out the kink and restore the relaxed curvature.Following this, angiography revealed no residual type i endoleak.".

Event Description

Report from the physician stated, "we then turned our attention to the endovascular portion of the procedure a 6 french dry seal sheath was then placed.Angiography of the aortic arch was performed following which we deployed a 28 x 104 mm relay pro nbs device.We landed it midway between the subclavian artery and common carotid artery origins in order to allow for the length of the device to reach beyond the anticipated distal seal zone.However, during deployment the device seemed to shorten as it followed the aneurysmal segment of the abnormality and because of that there was only marginal distal seal and the type lb endoleak was noted.We therefore extended distally using a 30 x 104 mm (28-n4-30-104-30x, lot # 171108169) relay pro nbs device.Injection revealed good positioning and no evidence of endoleak.There was noted kinking between the first and second stent units of the device but with maintained brisk flow across the area of angulation." on (b)(6) 2018, the subject underwent a follow-up ct angiogram of the chest and was found to have an endoleak, likely type i in the proximal descending thoracic aorta at the junction of the two stent grafts.In addition, the scan showed a new small bilateral pleural effusion and upper abdominal ascites.Patient outcome - "on (b)(6) 2018, the decision was made to undergo secondary intervention for the endoleak with kinking.Revision of the thoracic aneurysm with extension of the endovascular graft was performed via access of the right femoral artery, a 28×100 mm relay pro was introduced and deployed flush with the origin of the left common carotid artery while ensuring sufficient overlap with the existing stent graft.The stent graft followed the acute kink present at the apex of the aortic curvature and the area was dilated with a coda balloon to iron out the kink and restore the relaxed curvature.Following this, angiography revealed no residual type i endoleak.".

• 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: 14146173
• MDR Text Key: 289684175
• Report Number: 2247858-2022-00067
• 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: 06/21/2022

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: 02/02/2019
• Device Catalogue Number: 28-N4-28-104-28X
• Device Lot Number: 180206152
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/09/2022
• Initial Date FDA Received: 04/19/2022
• Supplement Dates Manufacturer Received: 04/09/2022
• Supplement Dates FDA Received: 06/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2018
• 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
• Patient Sex: Male