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

Model Number ETUF3614C102EE

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

Patient Problems Extravasation (1842); Fistula (1862); Hemorrhage/Bleeding (1888)

Event Date 06/08/2022

Event Type  Injury  

Event Description

An endurant ii stent graft system was implanted for the treatment of a symptomatic mycotic abdominal aortic aneurysm.  it was reported the patient presented emergently approximately 2.5 years post the index procedure.Ct showed the presence of an aorta duodenal fistula with herald bleed.The physician performed an intervention with bilateral cfa cut downs, bilateral cfa punctures and 7fr sheaths were inserted initially.An endurant aui stent graft was implanted and an endurant limb was deployed to extend the right side.  a digital subtraction angiography performed via the left side demonstrated a small volume of contrast extravasation into the duodenum.A left side 10fr sheath was inserted to allow deployment of 2 non-mdt ( interlock) coils deployed in the proximal left iliac limb followed by deployment of non-mdt (amplatzer plug), subsequent fem- fem crossover graft was then performed.It was reported the event was not resolved.  the consultants did not state that the aui graft failed as per the physician the cause of the fistula and bleed could not be determined.No additional clinical sequelae was provided and the patient will be monitored.

Manufacturer Narrative

Concomitant medical products: other relevant device(s) are: product id: etlw1616c82ee, serial/lot #: (b)(4), ubd: 28-sep-2023, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Film evaluation summary: the cause of aorto-duodenal fistula leading to bleeding could not be determined on the films provided.Lack of post-implant contrast cts did not allow for a more thorough assessment of contrast leakage/fistula and vessel/stent graft patency could not be performed.Analysis of the returned films did not reveal any obvious stent graft issues (endoleak with pressurization of the aneurysm sac, barb penetration of the aortic neck, graft migration, kink or fracture) that may have contributed to the formation of the reported aorto-duodenal fistula.Aorto-enteric fistulas can be formed due to friction between the stent graft material and the adjacent gastrointestinal tract.This can result in erosion into the gastrointestinal tract when not sufficiently supported by soft tissue and may lead to bleeding into the abdominal cavity.It is possible that the initially mycotic aneurysm may have also been a factor in the aorto-duodenal fistula formation, but this could not be confirmed.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 AUI 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: 14926919
• MDR Text Key: 295315928
• Report Number: 9612164-2022-02529
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 08/30/2022

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 Expiration Date: 04/27/2023
• Device Model Number: ETUF3614C102EE
• Device Catalogue Number: ETUF3614C102EE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/13/2022
• Initial Date FDA Received: 07/06/2022
• Supplement Dates Manufacturer Received: 08/05/2022
• Supplement Dates FDA Received: 08/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2021
• 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): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male