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

Catalog Number 28-D1-44-270-30X

Device Problem Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 09/10/2021

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 thoracic stent graft with plus delivery system approved for sale in the us (p110038).The relay branch related event occurred in the us.

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 aorta via the right femoral artery.Once the device was in the desired position, dr.Back started to advance the inner sheath/main body in the normal fashion.After the 1st stent exited the outer sheath, it was seen on the fluoro screen that the ds tip kept advancing, but the stent-graft and clasp were not advancing with it as they should.I immediately instructed the surgeon to stop the advancement.I looked down and the apex holder knob (step #3) was unlocked and retracted.It was deemed that we could not proceed with advancement and deployment of this device.The deployment grip was then retracted to bring the ds tip back to the graft/clasp and the device was removed.There was no deployment of the stent-graft.The incisions were closed, and the operation ended.The patient was extubated in the room, awake, and following commands moving all extremities.Dr.Arnaoutakis feels that it is a little too easy to unlock the apex holder knob.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 aorta via the right femoral artery.Once the device was in the desired position, dr.Back started to advance the inner sheath/main body in the normal fashion.After the 1st stent exited the outer sheath, it was seen on the fluoro screen that the ds tip kept advancing, but the stent-graft and clasp were not advancing with it as they should.I immediately instructed the surgeon to stop the advancement.I looked down and the apex holder knob (step #3) was unlocked and retracted.It was deemed that we could not proceed with advancement and deployment of this device.The deployment grip was then retracted to bring the ds tip back to the graft/clasp and the device was removed.There was no deployment of the stent-graft.The incisions were closed, and the operation ended.The patient was extubated in the room, awake, and following commands moving all extremities.(b)(6) dr.Feels that it is a little too easy to unlock the apex holder knob.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 thoracic stent graft with plus delivery system approved for sale in the us (p110038).The relay branch related event occurred in the us.

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 aorta via the right femoral artery.Once the device was in the desired position, dr.(b)(6) started to advance the inner sheath/main body in the normal fashion.After the 1st stent exited the outer sheath, it was seen on the fluoro screen that the ds tip kept advancing, but the stent-graft and clasp were not advancing with it as they should.I immediately instructed the surgeon to stop the advancement.I looked down and the apex holder knob (step #3) was unlocked and retracted.It was deemed that we could not proceed with advancement and deployment of this device.The deployment grip was then retracted to bring the ds tip back to the graft/clasp and the device was removed.There was no deployment of the stent-graft.The incisions were closed, and the operation ended.The patient was extubated in the room, awake, and following commands moving all extremities.Dr.(b)(6) feels that it is a little too easy to unlock the apex holder knob.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 thoracic stent graft with plus delivery system approved for sale in the us (p110038).The relay branch related event occurred in the us.Patient identifier in section a1 has been corrected from taa-0730 to taa-0688.

• Brand Name: RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY 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: 12597644
• MDR Text Key: 276872355
• Report Number: 2247858-2021-00093
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110038
• 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,Followup
• Report Date: 04/01/2022

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: 09/01/2022
• Device Catalogue Number: 28-D1-44-270-30X
• Device Lot Number: 2108160052
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/10/2021
• Initial Date FDA Received: 10/08/2021
• Supplement Dates Manufacturer Received: 09/10/2021; 09/10/2021
• Supplement Dates FDA Received: 03/04/2022; 04/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2021
• 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 Age: 75 YR
• Patient Sex: Male