MAUDE Adverse Event Report: MEDTRONIC IRELAND ENDURANT IIS BIFURCATED STENT GRAFT; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number ESBF3214C103E

Device Problems Leak/Splash (1354); Material Deformation (2976)

Patient Problems Obstruction/Occlusion (2422); Insufficient Information (4580)

Event Date 03/27/2024

Event Type  Injury  

Event Description

An endurant iis stent graft was implanted during the endovascular treatment of a 61x53mm abdominal aortic aneurysm on the patient had a short aortic neck at 11mm in length.The proximal renal diameter measured at 27mm, with mild thrombus and calcification noted in the proximal neck, and mild vessel calcification of the right and left iliac arteries.It was reported during the index procedure, the physician had to snare for access to the contralateral gate.After the grafts were implanted, ballooning was completed in the seal zones, overlap areas, and in the iliac limbs.Final run angio revealed a suspected type ii endoleak.Post-procedure, the patient had diminished pulse of the left foot.A ct scan for the left lower extremity was performed, where infolding of esbf3214c103e was observed.The patient underwent embolectomy for left lower extremity which was performed in the lower left extremity via a cutdown in the popliteal artery.There was no thrombus noted in the iliac limb.The source of the occlusion is not known, but the physician does not feel the proximal body is flow limiting to either limb or patency of the graft.The physician did not note any occlusion in either endurant limb.No further intervention for the infolding was performed.Per the physician the cause of the infolding was anatomy related and there was preexisting thrombus and calcification present in the aortic neck.The cause of the thrombotic occlusion was suspected to be anatomy related embolization with thrombus in the aorta.It was stated the patient was off the anticoagulant medication.No additional clinical sequalae were provided and the patient will be monitored.

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Manufacturer Narrative

Film evaluation summary: the reported stent graft infolding, endoleak and thrombus present in the left lower extremity were confirmed, on the images provided.The endoleak was assessed, as a type ii and possible type ia endoleak, likely related to the infolding.There was no oversizing noted, that could have been attributed to the infolding.It is possible, that pre-existing thrombus in the aorta may have contributed to the distal limb occlusion.No occlusion was noted, within the stent graft system.It was also stated, that the patient was off the anticoagulant medication.Other possible, contributors to vessel occlusion include an unknown coagulopathy, that is now presenting or a previous history of pad leading to poor distal run-off.Analysis of the returned films did not reveal any stent graft integrity issues.Correction to h6: ime/ annex e, codes.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank, because the information is currently, unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: ENDURANT IIS BIFURCATED STENT GRAFT
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 19141422
• MDR Text Key: 340565116
• Report Number: 9612164-2024-01879
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00643169439962
• UDI-Public: 00643169439962
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/18/2024

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?: Yes
• Device Operator: Health Professional
• Device Model Number: ESBF3214C103E
• Device Catalogue Number: ESBF3214C103E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2024
• Supplement Dates Manufacturer Received: 07/18/2024
• Supplement Dates FDA Received: 07/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2023
• 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: 89 YR
• Patient Sex: Male