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

Model Number	ETLW1610C156E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	03/12/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An endurant ii bifurcate stent graft system was implanted in the endovascular treatment of a 57mm abdominal aortic aneurysm.It was noted this procedure was successfully completed without any complications.It was reported that on the date of the ct, under two years later, it was noted the right endurant limb etlw1610c156e was occluded.The cause was the event was not reported.No additional clinical sequelae were provided and the patient will be monitored.
Additional Manufacturer Narrative
Additional information received:it was reported the occlusion extended to the endurant bifurcate main body stent graft.Product analysis summary: a pre-implant 3d ct report was received from 6 weeks prior to the index procedure: the reported occlusion event could not be confirmed on the films provided.Post-implant contrast ct¿s from 21 months post index procedure were received showing the endurant stent graft system implanted in the patient.The reported occlusion event was confirmed on the films provided; however, the cause of the event could not be fully determined.It is possible that the occlusive event was related to the extreme tortuosity of the right external iliac artery, overlapping devices and extension into the right external iliac leading to reduced stent graft lumen.The event may also have been caused by a patient condition: poor distal runoff, an unknown coagulopathy that is now presenting, or a previous history of pad.There appeared to be thrombus in the proximal aortic neck which led to a reduction in the flow lumen diameter.It is possible that this thrombus extended down the right side into the iliac limb to contribute to occlusion of the device.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.
Additional Manufacturer Narrative
Section d information references the main component of the system.Other relevant devices are: esbf3214c103ee; s/n: (b)(6); use by date: 2020-03-27; upn # 00643169439962 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.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.

• Brand Name: ENDURANT II ILIAC STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 10435992
• Report Number: 9612164-2020-03076
• Device Sequence Number: 2743996
• Product Code: MIH
• UDI-Device Identifier: 00643169467637
• UDI-Public: 00643169467637
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/19/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/07/2019
• Device Model Number: ETLW1610C156E
• Device Catalogue Number: ETLW1610C156E
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 08/05/2020
• Initial Date Received by Manufacturer: 08/05/2020
• Supplement Date Received by Manufacturer: 09/01/2020; 09/21/2020
• Initial Report FDA Received Date: 08/21/2020
• Supplement Report FDA Received Date: 09/30/2020; 10/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 74 YR