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

Model Number	ETLW1620C124E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/22/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section d information references the main component of the system.Other relevant device(s) are: product id: e tlw1620c124e, serial/lot #: (b)(4), ubd: 05-sep-2019, udi#: (b)(4).Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An endurant stent graft system was implanted in the endovascular treatment of a aaa.Nearly four and a half years later on a cta, a type ib endoleak was seen coming from one of the iliac limbs v07454577 or v07481055.It is unknown which stent graft has the ib as both stent grafts are the same size.15 days later an endurant ii limb etlw1613c146e was intended to be implanted as part of the endovascular treatment of the ib endoleak.The aaa measured 55mm.It was reported that during the procedure, the right internal iliac artery was coiled first before attempting to deliver the limb .After three attempts to deliver the stent graft it was discovered that the tapered tip was not flush with the rest of the delivery system and was getting hung up on the tight access site.It was confirmed there was a gap between the tapered tip and radiopaque ring thus causing the delivery system to not be smooth and the gap was catching on the anatomy not allowing it to advance through the vasculature.The device was not inspected until after the third attempt to deliver the limb and that is when it was discovered it was not a smooth transition between the tapered tip and radiopaque ring.The use of this stent graft was abandoned and alternately another endurant limb16x13x156 was then opened, delivered and deployed with no issues.Per the physician the cause of the delivery issue was the gap between the tapered tip and radiopaque ring. for a cause of the ib endoleak the physician believed the cause was that right common iliac aneurysm had grown or that the initial graft that was placed during the index procedure was undersized.The physician was not sure which scenario was the cause but did narrow it down to one of those two.No additional clinical sequalae were provided and the patient is fine.

• Brand Name: ENDURANT II ILIAC STENT GRAFT
• Common Device Name: 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: 16742783
• Report Number: 9612164-2023-01609
• Device Sequence Number: 14811291
• Product Code: MIH
• UDI-Device Identifier: 00643169467552
• UDI-Public: 00643169467552
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/14/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/20/2019
• Device Model Number: ETLW1620C124E
• Device Catalogue Number: ETLW1620C124E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2023
• Initial Report FDA Received Date: 04/14/2023
• Date Device Manufactured: 07/20/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: "SEE H10...."
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 85 YR
• Patient Sex: Male
• Patient Weight: 70 KG