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

Model Number	ETLW1624C156E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/26/2022
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 stent graft was implanted in a patient for the endovascular treatment of an 30mm iliac aortic aneurysm.It was reported approximately 8 years post the index procedure follow up ct identified a type ib endoleak with aneurysm growth in the internal iliac.Intervention was completed with coiling of the hypogastric artery and the limb was extended into the internal artery and the endoleak was resolved.Per physician the cause of the type ib endoleak was anatomy related where the aneurysm grew. no additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Product analysis conclusion: the reported type ib endoleak of the right limb was confirmed on the films provided; however the type ia n endoleak could not be confirmed.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.It most likely that the proximal endoleak was a type ia, but this could not be fully confirmed from the limited films available.Disease progression, as noted per the physician, with aneurysm morphology changes over the time of implant of the devices may have been a factor in the occurrence of the reported events.It is also possible that the aneurysmal right common iliac artery was being pressurized via the marginal distal seal.B5; additional information received : it was reported that a type ia endoleak was also identified on the bifurcate graft on the same day of the intervention.Endoanchors were implanted at rao of 35 and lao on both sides of graft and the endoleak resolved.The physician believes that the graft was properly sized during the initial procedure during initial procedure and the cause of the type ia endoleak was due to progression of aneurysmal disease.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 ILIAC 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: 13577039
• Report Number: 9612164-2022-00723
• Device Sequence Number: 4368453
• Product Code: MIH
• UDI-Device Identifier: 00613994991706
• UDI-Public: 00613994991706
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• 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): 03/24/2022

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: 01/07/2015
• Device Model Number: ETLW1624C156E
• Device Catalogue Number: ETLW1624C156E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2022
• Supplement Date Received by Manufacturer: 03/02/2022
• Initial Report FDA Received Date: 02/22/2022
• Supplement Report FDA Received Date: 03/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/07/2013
• 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: 71 YR
• Patient Sex: Male