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

Model Number ESBF3614C103E

Device Problems Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Renal Failure (2041); Thrombosis/Thrombus (4440)

Event Date 02/29/2024

Event Type  Injury  

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.

Event Description

An endurant iis stent graft was implanted during the endovascular treatment of a 50mm aaa.The aortic neck diameter measured 26mm at the right accessory renal, at 5mm below right accessory renal arteries its diameter was 27mm, 10mm below right accessory renal arteries was 29mm, and it measured 30mm 15mm below right accessory renal artery.The neck measured 20mm in length with thrombus.It was reported during the index procedure all devices were implanted with no issues and all stent grafts were ballooned using a reliant balloon.Upon completion angiogram the physician noted a crease in the main body ((b)(6)).The physician placed the reliant balloon back up and re ballooned the main body again and saw what looked like 2 separate lumens of the graft.Ivus was used to look at the graft and confirmed 2 separate lumens of the graft and what seemed like a stent strut hanging in the aorta and could not determine if the strut was broken.The physician then used 2 reliant balloons to try to iron out the graft, which did not work.During deployment, the markers all lined up before we released the tip capture and after tip capture released, 3 markers were all on the same side not circumferential.The physician turned attention to the supra renal hooks to see if they were hooked on each other.A tourguide was used to spin around to make sure the stents were not hung together.It was not clear if the stents were stuck on each other, so use of the tourguide was stopped.A small angioplasty balloon was placed up through the stents to try to change location to see if it would fix the problem.After a couple of hours of trying to fix the graft the physician took one final angiogram and saw no type i endoleak so decided to end the procedure.A ct scan 3 days post the index procedure was completed.The physician reviewed the pre images and saw the crease in the graft from the first angiogram and suspects that it might have been caused by the way the graft was loaded.Overnight the patients creatine levels jumped from.8 to 2.0 so a non-contrast ct was performed which showed a big end fold in the graft.3 weeks post the index procedure the patient was readmitted to hospital for an angiogram.Ct was first completed which showed some clot burden in the right limb.An angiogram showed a small piece of thrombus in the right external iliac.Anticoagulation medication was commenced.Per the physician the cause of the infolding is undetermined but questioned if it could be related to how the stent graft was loaded.No additional clinical sequalae were provided and the patient will be monitored.

• Brand Name: ENDURANT IIS BIFURCATED STENT GRAFT
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR
• 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: 18967313
• MDR Text Key: 338441873
• Report Number: 9612164-2024-01418
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00643169439955
• UDI-Public: 00643169439955
• 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
• Report Date: 03/25/2024

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: ESBF3614C103E
• Device Catalogue Number: ESBF3614C103E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/29/2024
• Initial Date FDA Received: 03/25/2024
• Date Device Manufactured: 09/15/2023
• 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): Other
• Patient Age: 56 YR
• Patient Sex: Female