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

Model Number ETBF2516C145EJ

Device Problem Leak/Splash (1354)

Patient Problems Disseminated Intravascular Coagulation (DIC) (1813); Shock (2072)

Event Date 01/30/2024

Event Type  Death  

Event Description

An endurant ii stent graft system was implanted during the emergency endovascular treatment of a 100mm abdominal aortic ruptured aneurysm.The patient presented with shock and was classified as fitzgerald classification type iv rupture.It was noted the evar procedure was carried out with only 10 units of blood available for transfusion.It was reported that during the index procedure, an occlusion balloon was inserted via the left upper arm, blood flow was blocked below the renal artery, and an endurant stent graft system was implanted.Disseminated intravascular coagulation (dic) occurred simultaneously, and a type iv endoleak was confirmed.Decompressive laparotomy was performed to counteract the abdominal compartment syndrome, the patient was transferred to the icu; however, the patient later expired.Per the physician the cause of the type iv endoleak was not specified and the cause of death was hemorrhagic shock due to abdominal aortic aneurysm rupture.No additional clinical sequelae were provided and the patient is expired.

Manufacturer Narrative

Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: e tlw1616c124ej, serial/lot #: (b)(6), ubd: 10-jan-2025, udi#: (b)(4) ; product id: etlw1616c82ej, serial/lot #: (b)(6), ubd: 26-jan-2025, udi#: (b)(4) ; product id: etlw1616c93ej, serial/lot #: (b)(6), ubd: 08-feb-2025, 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.

Manufacturer Narrative

Film evaluation summary: the reported endoleak seen immediately following implant was confirmed; however, the exact cause/source of the endoleak could not be fully determined from the films returned.The reported shock, dic and patient death could not be assessed.Lack of pre-implant ct¿s did not allow for a thorough assessment of the pre-implant anatomy.Endoleak interrogation via selective angiograms (injecting from different levels within the stent graft) to help determine the source and rule out other potential endoleak sources was not seen, and only a single imaging view point (a-p) was observed in the films provided; thereby, making determination of the endoleak difficult.This endoleak appears most likely to be an acute type iv blush endoleak caused by fabric porosity.Other factors such as heparin dose, outflow resistance, imaging quality, and volume of the aneurysm sac may have also contributed to this likely type iv endoleak.Analysis of the returned films did not reveal any out of specification stent graft integrity issues.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.

Manufacturer Narrative

B5; additional information received: it is unknown which stent graft contained the type iv endoleak.It is unclear per the physician whether the type iv endoleak, devices or procedure contributed to the patients death and associated complications.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.

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.

• Brand Name: ENDURANT II BIFURCATED STENT GRAFT
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• 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: 18675906
• MDR Text Key: 335011527
• Report Number: 9612164-2024-00703
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P100021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/30/2024

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: ETBF2516C145EJ
• Device Catalogue Number: ETBF2516C145EJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/01/2024
• Initial Date FDA Received: 02/09/2024
• Supplement Dates Manufacturer Received: 02/15/2024; 02/28/2024; 04/29/2024
• Supplement Dates FDA Received: 02/20/2024; 03/25/2024; 04/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/12/2022
• 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
• Treatment: "SEE H10...."
• Patient Outcome(s): Death
• Patient Age: 74 YR
• Patient Sex: Male