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

Model Number ESBF3614C103E

Device Problems Leak/Splash (1354); Mechanical Jam (2983); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Obstruction/Occlusion (2422); Insufficient Information (4580)

Event Date 09/30/2022

Event Type  Death  

Event Description

An endurant iis bifurcate stent graft system and endurant extension were implanted in the endovascular treatment of a 90mm aaa.  it was reported a ct showed an endoleak.An elective procedure was performed to explant the stent grafts due to an enlarging aaa and possible type ia endoleak. the type ia endoleak was confirmed during the explant procedure.It was reported the patient expired during this explant procedure.It was said the patient died due to complications resulting from the explant procedure.  the cause of the type ia endoleak was reported as disease progression.No additional clinical sequelae were provided and the patient is expired.

Manufacturer Narrative

Concomitant medical products: product id: etcf3636c49e, serial/lot #: (b)(4), ubd: 20-jun-2020, 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

Updated section h.6 film evaluation summary: the reported type ia endoleak and cause of death could not be confirmed on the films provided; therefore, the cause of the events could not be determined.Lack of pre-implant ct's did not allow for a thorough assessment of the pre-implant anatomy.Angiograms (including endoleak interrogation) could allow for a more comprehensive determinations of the endoleak source/cause.Earlier post-implant cts , which could allow for a more thorough assessment of the stent graft in vivo configuration over time were not available for review.It is possible that disease progression as noted by the physician, with aneurysm morphology changes since the time of implantation may have contributed to the reported endoleak, but this could not be confirmed.The suprarenal stent entanglement identified on the images may have also been a contributory factor to the reported endoleak.Occlusion of the ipsilateral limb of the main body graft and ipsilateral limb extension, which was relined with a non-medtronic stent graft was identified.Although the cause of the occlusion cannot be determined from the films provided, it is possible that overlapping devices which reduced the stent graft lumen and extension of the non-medtronic stent into the right external iliac artery may have been contributory factors to the occlusion.This 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.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 IIS BIFURCATED 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: 16239312
• MDR Text Key: 308064398
• Report Number: 9612164-2023-00372
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00643169439955
• UDI-Public: 00643169439955
• 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,Followup
• Report Date: 03/01/2023

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: 09/26/2020
• Device Model Number: ESBF3614C103E
• Device Catalogue Number: ESBF3614C103E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/13/2023
• Initial Date FDA Received: 01/25/2023
• Supplement Dates Manufacturer Received: 02/10/2023
• Supplement Dates FDA Received: 03/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2018
• 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; Other; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 65 KG