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

Model Number ETLW1616C93E

Device Problem Leak/Splash (1354)

Patient Problems Sepsis (2067); Embolism/Embolus (4438)

Event Date 05/18/2020

Event Type  Death  

Event Description

Valiant navion stent grafts were implanted during the endovascular treatment of a type 2 thoracoabdominal aortic aneurysm (zone 4-9).The 46x40 taper graft was placed just distal to lsca, followed by another 46x40.A thoracic bifurcated graft was then placed with a unitary manifold device in the upper abdominal aorta; individual stenting of celiac, sma with non mdt and self-expanding stents; individual stenting of renals with non mdt self-expanding stents was completed due to tortuosity; an extension distally with endurant 16x16x124; 16x21x99 limbs into iliacs.It was reported during the index procedure, completion angiogram showed a delayed type iv endoleak.Follow up ct one month post the index procedure noted "there are new foci of air that is seen within the native distal thoracic aorta outside the endograft.This could be related to recent manipulation of the endograft.Infectious process is are not excluded.It was reported the patient had a complicated post-op recovery following the index procedure and ultimately the patient was sent to inpatient rehab but suffered sepsis and expired next day approximately 2 months post the index procedure.Per the physician the cause of the endoleak is undetermined.In reference to the death the patient had a complicated post-op recovery following the index procedure resulting in sepsis and death.

Manufacturer Narrative

Continuation of d10: product id: etlw1616c93e, (serial: (b)(6)); product type: 0180-aortic stent graft; product id: vnmc4640c200tu, ((b)(6)); product type: 0180-aortic stent graft, implant date (b)(6) 2020, product id: endurant ii iliac stent graft; product id: etlw1616c124e (serial: (b)(6)); product type: 0180-aortic stent graft; implant date (b)(6) 2020.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.

• 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: 17919247
• MDR Text Key: 325478938
• Report Number: 9612164-2023-04621
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00643169467569
• UDI-Public: 00643169467569
• 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: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/12/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 01/27/2022
• Device Model Number: ETLW1616C93E
• Device Catalogue Number: ETLW1616C93E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/08/2023
• Initial Date FDA Received: 10/12/2023
• Date Device Manufactured: 01/28/2020
• 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
• Treatment: SEE H10...
• Patient Outcome(s): Death
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 68 KG