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

Model Number ETLW1628C93E

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Myocardial Infarction (1969)

Event Date 08/06/2023

Event Type  Death  

Manufacturer Narrative

Section d references the main component of the system.Other medical products in use during the event include: brand name endurant ii iliac stent graft; product id etlw1616c93e (serial: (b)(6)); product type: 0180-aortic stent graft; implant date (b)(6) 2023 ; brand name endurant ii iliac stent graft; product id etlw1620c156e (serial: (b)(6)); product type: 0180-aortic stent graft; implant date (b)(6) 2023; brand name endurant iis bifurcated stent graft; product id esbf3614c103e (serial: (b)(6)); product type: 0180-aortic stent graft; implant date (b)(6) 2023; brand name endurant ii iliac stent graft; product id etlw1620c93e (serial: (b)(6)); product type: 0180-aortic stent graft; implant date (b)(6) 2023; 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 Description

An endurant iis stent graft system was implanted in the emergent endovascular treatment of a ruptured aaa.  it was reported that during the procedure, the evar was successful and the aneurysm sealed.The patient subsequently expired.  per the physician the cause of death was the ruptured aneurysm and it was said a myocardial infraction was possible.  no additional clinical sequalae were provided and the patient is expired.

• Brand Name: ENDURANT II ILIAC 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: 17496969
• MDR Text Key: 320754095
• Report Number: 9612164-2023-03621
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00643169467415
• UDI-Public: 00643169467415
• 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: 08/10/2023

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 Model Number: ETLW1628C93E
• Device Catalogue Number: ETLW1628C93E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/06/2023
• Initial Date FDA Received: 08/10/2023
• Date Device Manufactured: 10/05/2022
• 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): Death
• Patient Age: 63 YR
• Patient Sex: Male