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

Catalog Number 28-N4-36-199-36U

Device Problem Failure to Align (2522)

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

Event Date 03/08/2023

Event Type  malfunction  

Event Description

Broken: a relay pro stent graft (34-154-34) was implanted on the proximal side and the relay pro stent graft concerned (36-199-36) was then attempted to be implanted on the distal side for a descending aortic aneurysm.After the stent graft concerned was deployed on the distal side, when the delivery system tip was attempted to be rejoined the outer sheath by placing the controller in position 4, the delivery system tip was not rejoined the outer sheath properly.The base of the delivery system tip and the tip of the outer sheath were broken, and they were rejoined in a way that one part was raised and protruded.Although details of the cause have not been confirmed as the rejoined part at the time of rejoin was not shown under fluoroscopy, they may have failed to be rejoined properly and broken as they were forcibly rejoined at a location where the artery was slightly bent.However, when the broken portions were checked in detail after removal of the delivery system, the base of the damaged delivery system tip was not tapered, which may have a structural problem compared to the delivery system that was removed without problems.The customer requested an investigation.Physician's comments: the physician felt something caught more than usual when the delivery system was removed from the patient's femoral artery, but the delivery system was removed without any major problems.Operation type: stent graft implantation.No blood loss.Image available.Pre-case plan will be available.Additional information will be able to be obtained.(b)(4).Patient outcome: "no health damage to the patient.".

Event Description

Broken: a relay pro stent graft (34-154-34) was implanted on the proximal side and the relay pro stent graft concerned (36-199-36) was then attempted to be implanted on the distal side for a descending aortic aneurysm.After the stent graft concerned was deployed on the distal side, when the delivery system tip was attempted to be rejoined the outer sheath by placing the controller in position 4, the delivery system tip was not rejoined the outer sheath properly.The base of the delivery system tip and the tip of the outer sheath were broken, and they were rejoined in a way that one part was raised and protruded.Although details of the cause have not been confirmed as the rejoined part at the time of rejoin was not shown under fluoroscopy, they may have failed to be rejoined properly and broken as they were forcibly rejoined at a location where the artery was slightly bent.However, when the broken portions were checked in detail after removal of the delivery system (see attached image-3), the base of the damaged delivery system tip was not tapered (right in image-3), which may have a structural problem compared to the delivery system that was removed without problems (left in image-3).The customer requested an investigation.Physician's comments: the physician felt something caught more than usual when the delivery system was removed from the patient's femoral artery, but the delivery system was removed without any major problems.Operation type: stent graft implantation no blood loss image available (see the attached 3 images) pre-case plan will be available additional information will be able to be obtained ((b)(4)).Patient outcome - "no health damage to the patient.".

• 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 ; 9548339699
• MDR Report Key: 16663557
• MDR Text Key: 312859278
• Report Number: 2247858-2023-00086
• 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: 06/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 28-N4-36-199-36U
• Device Lot Number: 2207130009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2022
• 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: 74 YR
• Patient Sex: Female