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

Model Number	ETTF3232C70E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/04/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
An endurant iis bifurcated stent graft was implanted for the endovascular treatment of a 55mm abdominal aortic aneurysm.  it was reported the patient presented to the hospital with abdominal pain.A ct taken showed the presence of a type ia endoleak.  the next day, a modified proximal endurant cuff was implanted to treat the type ia endoleak.The physician laser fenestrated both renal arteries and the sma.The renal arteries and sma were pre-stented with balloon expandable non mdt stents and landed the graft at the level of the celiac artery.Covered stents were implanted in each vessel.The final angiogram showed a small type i endoleak.A non-mdt cuff was landed to add additional overlap.After the cuff placement ballooning was performed and a final angiogram showed the leak had resolved with a faint blush. it was confirmed that the endurant cuff contained the fenestrations and after this graft was implanted an unknown endoleak suspected to be either a type i endoleak from the top, a fenestration endoleak or a type iiia due to insufficient overlap.The non mdt cuff was then placed to rule out not enough overlap.As per the physician the cause of the event was due to the patient's anatomy as a result of aortic neck degeneration.  no additional clinical sequelae was provided and the patient is fine.

• Brand Name: ENDURANT II EXTENSION 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: 15111943
• Report Number: 9612164-2022-02834
• Device Sequence Number: 14739619
• Product Code: MIH
• UDI-Device Identifier: 00613994991508
• UDI-Public: 00613994991508
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/27/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: ETTF3232C70E
• Device Catalogue Number: ETTF3232C70E
• 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: 07/04/2022
• Initial Report FDA Received Date: 07/27/2022
• Date Device Manufactured: 03/01/2022
• 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: 80 YR
• Patient Sex: Male