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

Model Number	ETLW1616C156E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/19/2021
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 iis stent graft system was implanted for the treatment of a suspected type iii endoleak in a previously implanted non mdt stent graft.The patient was originally treated for a 60mm right common iliac a aaa on an unknown date.It was reported during the procedure after the entire non mdt stent was religned during ballooning the reliant balloon burst.On final angio the suspected type iii endoleak was observed again.After further diagnostic testing the physician decided to reline the 16x16x156 limb with a 16x16x124 limb in the same area on the right side.The endoleak improved but remained and was now suspected to be a type ii endoleak.As per the physician the cause of the endoleak may have been due to the non mdt stents used to snorkel into left hypo during the initial implant of the non mdt device.It is believed that the balloon burst because a non-medtronic stent was used in a previous implanted non-medtronic graft which tore through fabric leading to balloon to burst during the relining of this graft with medtronic stents.No additional clinical sequalae was provided and the patient is fine.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An endurant iis stent graft system was implanted for the treatment of a suspected type iii endoleak in a previously implanted non mdt stent graft.The patient was originally treated for a 60mm right common iliac a aaa on an unknown date.It was reported during the procedure after the entire non mdt stent was religned during ballooning the reliant balloon burst.On final angio the suspected type iii endoleak was observed again.After further diagnostic testing the physician decided to reline the 16x16x156 limb with a 16x16x124 limb in the same area on the right side.The endoleak improved but remained and was now suspected to be a type ii endoleak.As per the physician the cause of the endoleak may have been due to the non mdt stents used to snorkel into left hypo during the initial implant of the non mdt device.It is believed that the balloon burst because a non-medtronic stent was used in a previous implanted non-medtronic graft which tore through fabric leading to balloon to burst during the relining of this graft with medtronic stents.No additional clinical sequalae was provided and the patient is fine.
Additional Manufacturer Narrative
Film evaluation summary: the reported endoleak that remained post implant of the endurant stent could not be assessed on the films provided, therefore, the cause of the event could not be determined.Endoleak interrogation via selective angiograms (injecting from different levels within the stent graft) to help determine the source and rule out other potential endoleak sources was not seen.Post-implant ct¿s were not available for review and the endurant iis stent graft in-vivo configuration could not be evaluated.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: 12959358
• Report Number: 9612164-2021-04752
• Device Sequence Number: 11210761
• Product Code: MIH
• UDI-Device Identifier: 00643169467668
• UDI-Public: 00643169467668
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 02/14/2022

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: 08/16/2023
• Device Model Number: ETLW1616C156E
• Device Catalogue Number: ETLW1616C156E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2021
• Supplement Date Received by Manufacturer: 01/27/2022
• Initial Report FDA Received Date: 12/08/2021
• Supplement Report FDA Received Date: 02/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2021
• 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: 65 YR
• Patient Sex: Male