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

Model Number	ENBF2513C166E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An endurant bifurcated stent graft was implanted during an endovascular procedure for the treatment of an abdominal aortic aneurysm it was reported the the patient returned for a follow-up and a ct showed the presence of type ia and type ib endoleaks.  no cause of the endoleaks as per the physician was provided.  no additional clinical sequalae was provided and the patient will be monitored.
Additional Manufacturer Narrative
Product analysis conclusion: the reported type ia and ib endoleak could not be confirmed on films provided; therefore , the cause of the events could not be determined.Lack of pre-implant ct¿s did not allow for a thorough assessment of the pre-implant anatomy.The post implant ct's received were non-contrast; therefore, no assessment of any endoleak, stent graft patency or thrombus could be performed.Angiograms (including endoleak interrogation) could allow for a more comprehensive determinations of the endoleak source/cause.It was reported by the physician that anatomical considerations , such as dilation of the aortic neck and iliac arteries were the cause of the reported endoleaks.B5; as per the physician, the cause of the type ia and ib endoleaks is due to continued dilatation of the aortic neck and common iliac arteries.It was reported that the limb model model enlw1620c124e, sn (b)(6)implanted during the index procedure on the (b)(6) 2012 also contained an endoleak type ib, as per the physician.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 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: 13693512
• Report Number: 9612164-2022-00914
• Device Sequence Number: 1869924
• Product Code: MIH
• UDI-Device Identifier: 00613994762252
• UDI-Public: 00613994762252
• 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: 2012
• 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): 04/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/25/2013
• Device Model Number: ENBF2513C166E
• Device Catalogue Number: ENBF2513C166E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2022
• Supplement Date Received by Manufacturer: 03/08/2022
• Initial Report FDA Received Date: 03/08/2022
• Supplement Report FDA Received Date: 04/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2011
• 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
• Patient Age: 80 YR
• Patient Sex: Male