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

Model Number	ETBF2513C166E
Medical Device Problem Codes	Leak/Splash (1354); Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An endurant ii bifurcate stent graft system was implanted in the endovascular treatment of a unknown sized abdominal aortic aneurysm.  it was reported approximately 2 years post the index procedure follow up ct, identified a type ib endoleak.It was noted the left iliac limb was in the sac with 3cms of iliac to seal.The right iliac limb had also pulled back but there was still seal.The physician decided to extend both iliac limbs.First after gaining access, the left iliac limb was extended by  placing a 16x20x82 iliac extension from the bifurcated graft to just above the internal iliac in the left common iliac artery.The limb was then ballooned using a reliant balloon.Then on the right iliac limb, the physician  placed a 20x20x82 extension in the right limb and extended to just about the right internal iliac in the common iliac artery.The limb was then ballooned.An angiogram was performed which showed the endoleak was resolved.The procedure was then completed.  as per the physician the cause of the ib endoleak was aneurysm reformation and iliac expansion.  no additional clinical sequalae were provided and the patient is fine.
Additional Manufacturer Narrative
It was reported that the bifurcate stent graft pulled up and had an endoleak type 1.The 1616124 limb also pulled up but there was no endoleak.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 BIFURCATED STENT GRAFT
• Common Device Name: 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: 12567013
• Report Number: 9612164-2021-03789
• Device Sequence Number: 11037920
• Product Code: MIH
• UDI-Device Identifier: 00613994991249
• UDI-Public: 00613994991249
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/13/2020
• Device Model Number: ETBF2513C166E
• Device Catalogue Number: ETBF2513C166E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2021
• Supplement Date Received by Manufacturer: 10/11/2021
• Initial Report FDA Received Date: 10/04/2021
• Supplement Report FDA Received Date: 11/09/2021
• Date Device Manufactured: 06/14/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male