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

Catalog Number 28-L2-17-100U

Device Problems Complete Blockage (1094); Obstruction of Flow (2423)

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

Event Date 09/01/2023

Event Type  Injury  

Event Description

"thrombotic embolism (acute occlusion of the right femoral artery): the treo was implanted on (b)(6) 2023.Although the proximal neck seemed to have straightened, the procedure was successfully completed without any endoleak.On (b)(6) 2023, acute occlusion of the right femoral artery occurred, and thrombus aspiration was performed as an additional treatment.Recanalization was confirmed to have achieved.Physician's comments on causal relationship: acute occlusion of the right femoral artery occurred to the patient who had the treo implanted, and thrombus aspiration was performed.The removed thrombus was old and organized even though this was acute limb ischemia (ali).No trouble at the puncture site or dissection of the external iliac artery was noted.For the source of the occlusion, cardiogenetic embolism is not considered as the patient has no arrhythmia and there was no thrombus in the left atrial appendage.In this case, although there was no bending of the leg or thrombus in the leg, it is suspected that a thrombus developed in the leg may have moved.The physician would like to know whether or not any similar cases were reported.Normally, the leg would likely be occluded in such a case, but the leg is straight enough that there is no such a concern.Operation type: stent-graft implantation.Blood loss: unknown.Image will be available.Pre-case plan will be available.Additional information will be able to be obtained.((b)(4))." patient outcome - "the patient's 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

"thrombotic embolism (acute occlusion of the right femoral artery): the treo was implanted on (b)(6) 2023.Although the proximal neck seemed to have straightened, the procedure was successfully completed without any endoleak.On (b)(6) 2023, acute occlusion of the right femoral artery occurred, and thrombus aspiration was performed as an additional treatment.Recanalization was confirmed to have been achieved.Physician's comments on causal relationship: acute occlusion of the right femoral artery occurred to the patient who had the treo implanted, and thrombus aspiration was performed.The removed thrombus was old and organized even though this was acute limb ischemia (ali).No trouble at the puncture site or dissection of the external iliac artery was noted.For the source of the occlusion, cardiogenetic embolism is not considered as the patient has no arrhythmia and there was no thrombus in the left atrial appendage.In this case, although there was no bending of the leg or thrombus in the leg, it is suspected that a thrombus developed in the leg may have moved.The physician would like to know whether or not any similar cases were reported.Normally, the leg would likely be occluded in such a case, but the leg is straight enough that there is no such a concern.Operation type: stent-graft implantation blood loss: unknown image will be available.Pre-case plan will be available.Additional information will be able to be obtained.(tc#bm 230900195)" patient outcome - "the patient's 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: 17794096
• MDR Text Key: 323982250
• Report Number: 2247858-2023-00250
• 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: 12/29/2023

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-L2-17-100U
• Device Lot Number: 2211290256
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/04/2023
• Initial Date FDA Received: 09/21/2023
• Supplement Dates Manufacturer Received: 09/01/2023
• Supplement Dates FDA Received: 12/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2022
• 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