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	Rupture (2208)
Date of Event	11/01/2021
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 stent graft system was implanted during an endovascular procedure for the treatment of a 64mm abdominal aortic aneurysm.It was reported approximately 4 years post the index procedure the pateint presented emergently with back pain and a ct was preformed where an aneurysm rupture was observed due to a type ib endoleak in the rcia.The aneurysm diameter is now noted as 130mm x 80mm.There was now 3cm of uncovered rcia.An endurant limb was inserted to resolve the endoleak and contain the rupture.The endoleak was sealed.  as per the physician the cause of the event was due to anatomy as the iliac continued to elongate and dilate over time.  no additional clinical sequalae was provided and the patient is fine.
Additional Manufacturer Narrative
Film evaluation summary: the reported endoleak type 1b was confirmed on the films provided, however the aneurysm rupture and cause of the endoleak could not be confirmed.Lack of post-implant ct¿s did not allow for a thorough analysis of the reported endoleak/aneurysm rupture and stent graft in vivo configuration.Endoleak interrogation via selective angiograms (injecting from different levels within the stent graft) could allow for a more comprehensive determination of the endoleak source/cause and only a single imaging view point (a-p) was observed in the films provided.Analysis of the returned report did not reveal any out of specification stent graft integrity issue.It is likely that disease progression over the 4 years of implantation with aneurysm morphology changes (iliac dilatation) as seen with the tortuous iliac limb, may have contributed to these events.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.

• 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: 12769827
• Report Number: 9612164-2021-04282
• Device Sequence Number: 4151780
• Product Code: MIH
• UDI-Device Identifier: 00643169467569
• UDI-Public: 00643169467569
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 01/11/2022

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: 07/19/2018
• Device Model Number: ETLW1616C93E
• Device Catalogue Number: ETLW1616C93E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2021
• Supplement Date Received by Manufacturer: 12/15/2021
• Initial Report FDA Received Date: 11/08/2021
• Supplement Report FDA Received Date: 01/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/19/2016
• 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: Other; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 67 KG