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

Catalog Number 28-L2-09-120U

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

Patient Problems Obstruction/Occlusion (2422); Thromboembolism (2654); Thrombosis/Thrombus (4440)

Event Date 01/22/2024

Event Type  Injury  

Event Description

"occlusion: evar was performed for an abdominal aortic aneurysm of approximately 60mm.Ct scan on (b)(6) 2023 showed no problems, but the patient came to the hospital with leg pain beginning around december 25.Ct scan showed that the treo leg extension stent-graft was occluded from the central to the peripheral.On (b)(6) 2024, thrombectomy was performed using a fogarty (edwards lifesciences), and a bare stent was additionally implanted.Physician's comment: additional treatment was needed for the patient with poor cardiac function with ef15%.Please provide the details of the cases and the incidence of the occlusion of the treo leg extension (9 mm).Operation type: evar blood loss: amount is unknown.No image available pre-case plan available no additional information available" patient outcome - "the patient was in serious condition and the outcome 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.

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

"occlusion: evar was performed for an abdominal aortic aneurysm of approximately 60mm.Ct scan on (b)(6 2023 showed no problems, but the patient came to the hospital with leg pain beginning around (b)(6).Ct scan showed that the treo leg extension stent-graft was occluded from the central to the peripheral.On ,(b)(6) 2024, thrombectomy was performed using a fogarty (edwards lifesciences), and a bare stent was additionally implanted.Physician's comment: additional treatment was needed for the patient with poor cardiac function with ef15%.Please provide the details of the cases and the incidence of the occlusion of the treo leg extension (9 mm).Operation type: evar blood loss: amount is unknown.No image available pre-case plan available no additional information available" patient outcome - "the patient was in serious condition and the outcome is unknown.".

• 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: 18627551
• MDR Text Key: 334368831
• Report Number: 2247858-2024-00046
• 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: 04/02/2024

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 Operator: Health Professional
• Device Catalogue Number: 28-L2-09-120U
• Device Lot Number: 2107260384
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/22/2024
• Initial Date FDA Received: 02/01/2024
• Supplement Dates Manufacturer Received: 01/22/2024
• Supplement Dates FDA Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/20/2021
• 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 Outcome(s): Required Intervention
• Patient Age: 99 YR