MAUDE Adverse Event Report: BOLTON MEDICAL, INC. TREO ABDOMINAL STENT-GRAFT SYSTEM; STENT, ENDOVASCULAR GRAFT, AORTIC

Catalog Number 28-B2-24-100U

Device Problems Difficult or Delayed Activation (2577); Malposition of Device (2616); Migration (4003); Separation Problem (4043)

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

Event Date 07/21/2023

Event Type  malfunction  

Manufacturer Narrative

Bolton medical, inc.(d/b/a terumo aortic), herein known as the "company", is submitting this report pursuant to 21 cfr part 803, has made reasonable efforts to obtain complete information, and has provided as much as is available to the company as of the submission date of this report.This report is based on information obtained by the company, which may not have been able to fully investigate or verify prior to the date the report was required by the regulations.Any required fields that are unpopulated are blank because the information is currently unknown, unavailable, or not applicable.This report does not constitute an admission or a conclusion by anyone that the device caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the certain regulations, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Event Description

"unable to deploy: the treo main bifurcation stent graft was inserted through the inguinal region of the left femoral artery and deployment was initiated with the device aligned with just below the renal artery.Normally, the contralateral leg of the main bifurcated stent graft would be fully deployed first, but in this case, but due to the short length from just below the renal artery to the terminal aorta, only two stents of the contralateral leg was deployed and then the bare stent of the main bifurcated stent graft was attempted to be deployed first.The release grip was pulled backwards but the bare stents were not deployed.There was a possibility that the bare stent might have been caught, so the delivery system was rotated, advanced, and retracted, but the bare stent was not deployed.There was a possibility that the bare stent had been caught, so the delivery system was rotated, advanced, and retracted, but the bare stent was not deployed.In accordance with the ifu troubleshooting procedure, the green tube was then pinched with forceps but could not be pulled out successfully.The bare stent was deployed by cutting the green tube with a scalpel and pulling it out with forceps.As a result, the bare stent could be deployed, but the main bifurcated stent graft was placed peripherally from the planned implantation position because it took a long time to deploy the bare stent and the delivery system was moved back and forth, left and right.This made it difficult to deploy the contralateral leg extension stent graft due to the short length of the treatment site.The contralateral leg extension stent graft was managed to be deployed within the aneurysm by advancing and retracting the delivery system, but the contralateral leg gate was deployed crushed by the aneurysm wall, making cannulation impossible.As cannulation for deployment of a contralateral leg extension could not be performed, implantation of the contralateral leg extension was given up.A contralateral excluder leg (plc231000j, gore) was placed from the middle part of the treo main bifurcated stent graft to beyond the end of the ipsilateral leg.The central side of the treo main bifurcated stent graft was then fixed with an excluder cuff (gore).After confirming that there were no leaks by angiography, a vascular plug (st.Jude medical) was implanted in the right common iliac artery to prevent blood from entering the aneurysm through the right common iliac artery.The procedure was somehow completed using the f-f bypass technique with a fusion vascular graft (8mm x 40cm, cosmotec).Operation type: evar.Blood loss: amount is unknown.Ancillary devices: excluder leg (plc231000j, gore), excluder cuff, fusion (8mm x 40cm, cosmotec).No image available no pre-case plan available.No additional information available.(tc#bm230702225)".Patient outcome - "the patient was not in serious condition.The current condition is unknown.".

Event Description

"unable to deploy: the treo main bifurcation stent graft was inserted through the inguinal region of the left femoral artery and deployment was initiated with the device aligned with just below the renal artery.Normally, the contralateral leg of the main bifurcated stent graft would be fully deployed first, but in this case, but due to the short length from just below the renal artery to the terminal aorta, only two stents of the contralateral leg was deployed and then the bare stent of the main bifurcated stent graft was attempted to be deployed first.The release grip was pulled backwards but the bare stents were not deployed.There was a possibility that the bare stent might have been caught, so the delivery system was rotated, advanced, and retracted, but the bare stent was not deployed.In accordance with the ifu troubleshooting procedure, the green tube was then pinched with forceps but could not be pulled out successfully.The bare stent was deployed by cutting the green tube with a scalpel and pulling it out with forceps.As a result, the bare stent could be deployed, but the main bifurcated stent graft was placed peripherally from the planned implantation position because it took a long time to deploy the bare stent and the delivery system was moved back and forth, left and right.This made it difficult to deploy the contralateral leg extension stent graft due to the short length of the treatment site.The contralateral leg extension stent graft was managed to be deployed within the aneurysm by advancing and retracting the delivery system, but the contralateral leg gate was deployed crushed by the aneurysm wall, making cannulation impossible.As cannulation for deployment of a contralateral leg extension could not be performed, implantation of the contralateral leg extension was given up.A contralateral excluder leg (plc231000j, gore) was placed from the middle part of the treo main bifurcated stent graft to beyond the end of the ipsilateral leg.The central side of the treo main bifurcated stent graft was then fixed with an excluder cuff (gore).After confirming that there were no leaks by angiography, a vascular plug (st.Jude medical) was implanted in the right common iliac artery to prevent blood from entering the aneurysm through the right common iliac artery.The procedure was somehow completed using the f-f bypass technique with a fusion vascular graft (8mm x 40cm, cosmotec).Operation type: evar.Blood loss: amount is unknown.Ancillary devices: excluder leg (plc231000j, gore), excluder cuff, fusion (8mm x 40cm, cosmotec).No image available.No pre-case plan available.No additional information available.(b)(4)".Patient outcome - "the patient was not in serious condition.The current condition is unknown.".

Manufacturer Narrative

Bolton medical, inc.(d/b/a terumo aortic), herein known as the "company", is submitting this report pursuant to 21 cfr part 803, has made reasonable efforts to obtain complete information, and has provided as much as is available to the company as of the submission date of this report.This report is based on information obtained by the company, which may not have been able to fully investigate or verify prior to the date the report was required by the regulations.Any required fields that are unpopulated are blank because the information is currently unknown, unavailable, or not applicable.This report does not constitute an admission or a conclusion by anyone that the device caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the certain regulations, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

• Brand Name: TREO ABDOMINAL 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: 17474296
• MDR Text Key: 320599543
• Report Number: 2247858-2023-00206
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P190015
• 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: 10/02/2023

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 Catalogue Number: 28-B2-24-100U
• Device Lot Number: 2212020039
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/27/2023
• Initial Date FDA Received: 08/07/2023
• Supplement Dates Manufacturer Received: 07/27/2023
• Supplement Dates FDA Received: 10/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2022
• 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 Outcome(s): Required Intervention
• Patient Age: 99 YR
• Patient Sex: Male