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

Model Number	ETBF3616C166E
Medical Device Problem Codes	Fracture (1260); Leak/Splash (1354); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Aneurysm (1708); Insufficient Information (4580)
Date of Event	01/21/2022
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 bifurcated stent graft was implanted during the endovascular treatment of a 55-65mm abdominal aortic aneurysm.It was reported on an unknown date aaa expansion was identified.The patient was scheduled and brought back to the or for a transcaval embolization of the aaa sac due to the expansion.A stent graft fracture was identified on the fluoroscopy/ xray image during the procedure.As per the physician the cause of the event could not be determined.No additional clinical sequalae was provided and the patient will be monitored.
Additional Manufacturer Narrative
Additional information received: it was reported that on review of the imaging again it did not appear that the stent graft has any stent fractures on the fluoroscopy/ xray image.It appears that only graft fabric had tore away from the supra renal stents which led to a proximal endoleak also.This event was noted by the physician on (b)(6)2022.A chevar procedure was schedule to be performed on the (b)(6) 2022.It was reported that the patient was prepped for the procedure but during the right groin exposure there was some complications with bleeding.The patient was stabilised, the artery and groin cut down were closed and the endoleak repair was aborted.Film evaluation summary: the reported stent graft severance was confirmed on the films provided; however, the cause of the event could not be fully determined.There was no contrast visible on the film provided; therefore, endoleaks could not be assessed.The proximal margin of bifurcate graft material appeared to be sitting further distally due to the stent severance which likely resulted in the reported proximal type ia endoleak.Lack of pre-implant ct's did not allow for a thorough assessment of the pre-implant anatomy.It is possible that anatomical considerations and disease progression (e.G.Angulation, calcification , neck dilatation etc) may have been a factor in the separation of the suprarenal stents.Anatomical changes overtime may have led to lack of stent graft proximal neck radial support and increased loading of the graft fabric and/or sutures at the suprarenal stent to bifurcate fabric attachment, with eventual failure of the graft fabric/sutures.No suprarenal or aortic bifurcate body stent fractures were observed.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: 13357838
• Report Number: 9612164-2022-00339
• Device Sequence Number: 14698565
• Product Code: MIH
• UDI-Device Identifier: 00613994991041
• UDI-Public: 00613994991041
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 02/22/2022

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: 02/15/2018
• Device Model Number: ETBF3616C166E
• Device Catalogue Number: ETBF3616C166E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2022
• Supplement Date Received by Manufacturer: 01/26/2022
• Initial Report FDA Received Date: 01/26/2022
• Supplement Report FDA Received Date: 02/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/16/2016
• 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: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male