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

Model Number	ETLW1616C93E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/02/2022
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 stent graft system was implanted for the endovascular treatment of a 70cm abdominal aortic aneurysm.It was reported the patient presented emergently approximately 7 years post the index procedure.Ct showed a type ib endoleak from the left common iliac due to expansion of the native iliac artery.The right common iliac artery had also expanded but there was no endoleak observed.The proximal main body graft had no type ia endoleak or loss or seal, but was 7mm distal to the renal arteries.The physician determined that there was not enough area below the left iliac graft to flare a limb.The physician then coiled the left hypogastric artery, and extended into the left external iliac artery with a etlw1616c93e ((b)(4)).There was about 1cm of distance from the right limb of the graft (no type 1b leak), so the physician placed a etlw1620c93e ((b)(4)) to maintain a seal in the right common iliac.A etcf2525c49e ((b)(4)) was then placed inside the main body of the endurant graft at the level of the renal arteries.The physician then placed heli-fx endoanchors at the top of the placed cuff.Ivus showed that the left hypogastric artery was not yet thrombosed and receiving collateral blood flow from the right hypogastric artery.It was still pulsatile causing the old and newly placed limb on the left, to be dynamic and pulsatile.2 non-mdt stents were placed inside of the left common iliac endurant grafts.A final angio was performed and there was no leak from any of the limbs or the proximal neck.An ivus was performed and revealed there was no pulsatile activity observed in the left.The limb was not occluded and it appeared to be opening/closing during systolic/diastolic heart rate.As per the physician the cause of the event was as a result of the patients own anatomy as a result of normal vessel dilation.No additional clinical sequalae was provided and the patient is fine.

• 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: 15112043
• Report Number: 9612164-2022-02837
• Device Sequence Number: 5200824
• Product Code: MIH
• UDI-Device Identifier: 00643169467569
• UDI-Public: 00643169467569
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: 05/02/2024
• Device Model Number: ETLW1616C93E
• Device Catalogue Number: ETLW1616C93E
• 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: 07/02/2022
• Initial Report FDA Received Date: 07/27/2022
• Date Device Manufactured: 05/03/2022
• 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: 81 YR
• Patient Sex: Male