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

Catalog Number 28-DH-44-270-34X

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/09/2022

Event Type  malfunction  

Manufacturer Narrative

Bolton medical is voluntarily reporting a device malfunction related to the relay branch thoracic stent-graft system.The relay branch device is not marketed in the us; however it is similar to the relay pro thoracic stent graft system approved for sale in the us (p200045).The relay branch related event occurred in the us.This relay branch device was used in compassionate use case (b)(4).

Event Description

The device was flushed on the back table and all components including the apex holder knob were in the appropriate positions.The device was brought to the surgical table and inserted into the patient's access vessel via a right common iliac artery conduit.When the device was being advanced in the descending aorta it was noted under fluoroscopy that the tip started to separate from the sheath.The case was paused to analyze if the proximal clasp had separated from the distal clasp.After it was confirmed to still be in place and it was decided to proceed slowly to the deployment site.The graft was deployed successfully and in the intended landing zone with no damage to the patient.This is the second attempt for this compassionate use case, the first one being in november of 2021.A similar failure occurred during this case where the proximal clasp did separate from the distal clasp and the case was aborted.At the time the failure was attributed to the icast device that was caught on the relaybranch delivery system causing a potential wedge between the tip and the outer sheath.The patient had severe scoliosis, small iliacs/access, and previously implanted endovascular devices that could have potentially affected the mechanics of the deployment.Patient outcome - "there was no negative outcome/patient injury due to this event.".

Event Description

The device was flushed on the back table and all components including the apex holder knob were in the appropriate positions.The device was brought to the surgical table and inserted into the patient's access vessel via a right common iliac artery conduit.When the device was being advanced in the descending aorta it was noted under fluoroscopy that the tip started to separate from the sheath.The case was paused to analyze if the proximal clasp had separated from the distal clasp.After it was confirmed to still be in place and it was decided to proceed slowly to the deployment site.The graft was deployed successfully and in the intended landing zone with no damage to the patient.This is the second attempt for this compassionate use case, the first one being in (b)(6) 2021.A similar failure occurred during this case where the proximal clasp did separate from the distal clasp and the case was aborted.At the time the failure was attributed to the icast device that was caught on the relaybranch delivery system causing a potential wedge between the tip and the outer sheath.The patient had severe scoliosis, small iliacs/access, and previously implanted endovascular devices that could have potentially affected the mechanics of the deployment.Patient outcome - "there was no negative outcome/patient injury due to this event.".

Manufacturer Narrative

Bolton medical is voluntarily reporting a device malfunction related to the relay branch thoracic stent-graft system.The relay branch device is not marketed in the us; however it is similar to the relay pro thoracic stent graft system approved for sale in the us ((b)(6)).The relay branch related event occurred in the us.This relay branch device was used in compassionate use case (b)(4).

• Brand Name: RELAY BRANCH 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: 13534082
• MDR Text Key: 288360361
• Report Number: 2247858-2022-00030
• 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: 07/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/23/2023
• Device Catalogue Number: 28-DH-44-270-34X
• Device Lot Number: 2201050131
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/09/2022
• Initial Date FDA Received: 02/15/2022
• Supplement Dates Manufacturer Received: 02/09/2022
• Supplement Dates FDA Received: 07/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2022
• 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: 73 YR
• Patient Sex: Female