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

Catalog Number 28-L2-15-100U

Device Problems Obstruction of Flow (2423); Patient Device Interaction Problem (4001)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 02/27/2024

Event Type  Injury  

Manufacturer Narrative

This complaint was involved with three devices.Device 1 is being reported under mdr 2247858-2024-00082, device 2 is being reported under mdr device 3 is being reported under mdr 2247858-2024-00091.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

"occlusion: on (b)(6) 2024, evar was performed using the treo device.A main bifurcated stent graft was inserted from the right femoral artery and deployed, and the ipsilateral leg extension stent graft and a contralateral leg extension stent graft were deployed, landing in both common iliac arteries.No endoleak or vessel occlusion was observed.On february 23, 2024, the patient was examined for intermittent claudication.Angiographic ct images revealed a thrombotic occlusion from the bifurcation of the main bifurcated stent graft to the right external iliac artery.The patient was scheduled to undergo thrombectomy on february 27.According to the physician, the right common iliac artery was originally dissected and was not in good condition.Operation type: evar ancillary devices: 28-b2-26-100u (main bifurcated stent graft) and 28-l2-15-080u (contralateral leg extension) no image available pre-case plan available no additional information available (tc#bm240203519)" patient outcome - "the patient was in serious condition and has not recovered.".

Manufacturer Narrative

This complaint was involved with three devices.Device 1 is being reported under mdr 2247858-2024-00082, device 2 is being reported under mdr 2247858-2024-00090, and device 3 is being reported under mdr 2247858-2024-00091.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

"occlusion: on (b)(6) 2024, evar was performed using the treo device.A main bifurcated stent graft was inserted from the right femoral artery and deployed, and the ipsilateral leg extension stent graft and a contralateral leg extension stent graft were deployed, landing in both common iliac arteries.No endoleak or vessel occlusion was observed.On (b)(6)2024, the patient was examined for intermittent claudication.Angiographic ct images revealed a thrombotic occlusion from the bifurcation of the main bifurcated stent graft to the right external iliac artery.The patient was scheduled to undergo thrombectomy on (b)(6).According to the physician, the right common iliac artery was originally dissected and was not in good condition.Operation type: evar.Ancillary devices: 28-b2-26-100u (main bifurcated stent graft) and 28-l2-15-080u (contralateral leg extension).No image available.Pre-case plan available.No additional information available.(tc#bm240203519)".Patient outcome - "the patient was in serious condition and has not recovered.".

• 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: 18978385
• MDR Text Key: 338595826
• Report Number: 2247858-2024-00090
• 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: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/03/2024

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 Catalogue Number: 28-L2-15-100U
• Device Lot Number: 2308220222
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/27/2024
• Initial Date FDA Received: 03/26/2024
• Supplement Dates Manufacturer Received: 02/27/2024
• Supplement Dates FDA Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/01/2023
• 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: Female