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

Model Number	ETLW1616C146E
Medical Device Problem Codes	Obstruction of Flow (2423); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Obstruction/Occlusion (2422); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
An endurant iis bifurcate stent graft system was implanted in the endovascular treatment of a 50mm aaa.  it was reported a ct was performed approximately 4 months post the indes procedure, which revealed the proximal portion of the endurant limb 16x16x146  was compressed with thrombus formation.  the ct also revealed a stent strut lying transverse across the proximal portion of the 16x16x93 limb.There appears to be a stent that is detached.It was also noted that there are misplaced stents seen on the ct but it is undetermined if they are from the bifurcate stent graft or the limb stent graft.There was no restriction of flow or thrombus noted in the 16 x 16 x 90 limb ot endurant bifurcate.The patient is asymptomatic.  per the physician the cause could not be determined.  no additional clinical sequelae were provided and the patient will be monitored.
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.
Additional Manufacturer Narrative
Additional information received: intervention was performed 5 months post index procedure where a non-medtronic stent was implanted in the proximal limb just below the flow divider.Imaging after the stent placement showed resolution of the compression previously seen on ct and fluoroscopic imaging before stent placement.The detached stent was seen stretching from the proximal right limb across the flow divider and across the lumen of the proximal left limb.Where the stent originated could not be determined.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.
Additional Manufacturer Narrative
Additional information received: it was reported that the patient coded 15 minutes after the procedure after receiving (b)(4) units of protamine.The patient was successfully resuscitated and was alive per the last communication with the physician on (b)(6) 2023 one day post-intervention).Film evaluation summary: the reported stent compression with thrombus formation was confirmed on the films provided; however, the cause of the event could not be determined.The stent fracture could not be fully confirmed.The event appears most likely to have been a stent deformation.Angiogram videos from the index procedure did not show the exact moment of deployment of the limbs and the quality of the images did not allow for thorough assessment of the stent graft integrity.It is possible that the likely stent deformation occurred at index, during limb stent graft deployment and contributed to the stent stenosis, but this could not be confirmed.Other possible contributing factors include the pre-existing vessel thrombus and overlapping devices which can reduce the stent graft lumen.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: 17369625
• Report Number: 9612164-2023-03334
• Device Sequence Number: 17112357
• Product Code: MIH
• UDI-Device Identifier: 00763000519957
• UDI-Public: 00763000519957
• 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: 2023
• 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,Followup
• Report Date (Section B): 08/21/2023

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: 10/23/2024
• Device Model Number: ETLW1616C146E
• Device Catalogue Number: ETLW1616C146E
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 06/26/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2023
• Supplement Date Received by Manufacturer: 07/24/2023; 07/27/2023
• Initial Report FDA Received Date: 07/21/2023
• Supplement Report FDA Received Date: 07/27/2023; 08/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2022
• 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: Other; Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male