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

Model Number	ETBF2813C166E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
An endurant ii bifurcated stent graft was implanted during an endovascular procedure for the treatment of a 52mm abdominal aortic an eurysm.It was reported that patient had a ct, it was noted that there is a type ia endoleak from the top of the graft 2cm distal to the lowest renal artery and a possible questionable type iii endoleak at the flow divider.As per the physician the cause of the type ia endoleak could not be determined. no additional clinical sequalae was provided and the patient will be monitored.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product analysis conclusion: the reported type ia endoleak was confirmed on the films provided; however the cause of the event could not be fully determined.Lack of pre implant ct's did not allow for a thorough assessment of the pre-implant anatomy and earlier post-implant ct's were not available for comparison.It is possible that anatomical changes and disease progression over the 7.5 years since implantation may have contributed to loss of seal leading to the proximal type ia endoleak.The type of contrast leakage observed further distally at the level of the flow divider could not be fully determined.A type iiia junctional endoleak seems unlikely to have occurred as there appeared to be sufficient component overlap.A type iiib endoleak cannot be ruled out; however , analysis of the returned films did not reveal any obvious anatomical anomalies that could have led to a type iiib fabric endoleak (e,g, calcification).Apart from the observed sharp stent graft angulation , there were no obvious out of specification stent graft integrity issues noted.It is also possible that the contrast leakage seen on the left lateral side of the main body stent graft at the level of the flow divider may have been contrast from the proximal endoleak that had spread distally into the aneurysm sac.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 approximately 4 months after the endoleak was identified.An endurant cuff (b)(6) and 6 endoanchors were implanted which resolved the type ia endoleak.It was confirmed there was no type iii endoleak present.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 BIFURCATED 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: 14390809
• Report Number: 9612164-2022-01796
• Device Sequence Number: 6714578
• Product Code: MIH
• UDI-Device Identifier: 00613994991300
• UDI-Public: 00613994991300
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 09/21/2022

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: 03/19/2016
• Device Model Number: ETBF2813C166E
• Device Catalogue Number: ETBF2813C166E
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 05/12/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2022
• Supplement Date Received by Manufacturer: 06/01/2022; 08/30/2022
• Initial Report FDA Received Date: 05/13/2022
• Supplement Report FDA Received Date: 06/24/2022; 09/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2014
• 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: 79 YR
• Patient Sex: Male