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

Model Number	ENBF2816C145E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Rupture (2208); Syncope/Fainting (4411)
Date of Event	10/14/2021
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 bifurcate stent graft system was implanted in the endovascular treatment of a unknown sized abdominal aortic aneurysm.  it was reported the patient presented emergently approximately 9 years and 2 months post index procedure for fainting.It was discovered that the patient had a contained aortic rupture and a type ia endoleak.  intervention was performed the next day, the physician was able to cannulate the type ia endoleak and was able to deploy several coils into the aneurysm sac and into the endoleak channel.The physician  then implanted a  non mdt  cuff and finally placed 3 heli fx endoanchors.This resolved the event.  as per the physician the cause of the rupture was the posterior type ia endoleak and the cause of the ia endoleak is unknown.  no additional clinical sequelae were provided and the patient is fine.
Additional Manufacturer Narrative
Product analysis conclusion; the type ia endoleak and the contained aneurysm rupture that may have led to the fainting event could not be confirmed on the films provided.Lack of pre-implant ct¿s did not allow for a thorough assessment of the pre-implant anatomy.Post-implant ct¿s were not available for review for a more thorough analysis of the stent graft in-vivo configuration.Post-implant angiograms (including endoleak interrogation) could allow for a more comprehensive determination of the endoleak source/cause.It is possible that the noted 5mm proximal aortic neck was a factor in the occurrence of the type ia endoleak.Disease progression with aneurysm morphology changes over the 9 years of implantation of the device may have contributed but this could not be confirmed.B5; additional information received : it was reported that positioning the intensifier (¿eye-eye¿ )so that helifx endoanchors could be placed in the posterior aspect of the aorta was not feasible in this case.The physician was aware of this limitation and thus the plan for treating the type ia endoleak included cuff placement, coils and endoanchors.The physician was satisfied with the result.It was noted that the completion angiogram was done prior to heparin reversal.It was initially reported that the size of the treated ruptured aneurysm was 55mm.The length of the proximal aortic neck was noted to measure 5mm and the diameter of the aorta at renal artery was 24mm.Moderately vessel calcification was reported.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: 12717779
• Report Number: 9612164-2021-04121
• Device Sequence Number: 14564053
• Product Code: MIH
• UDI-Device Identifier: 00613994762498
• UDI-Public: 00613994762498
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 12/02/2021

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: 09/20/2013
• Device Model Number: ENBF2816C145E
• Device Catalogue Number: ENBF2816C145E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2021
• Supplement Date Received by Manufacturer: 11/11/2021
• Initial Report FDA Received Date: 10/29/2021
• Supplement Report FDA Received Date: 12/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2011
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Male