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

Model Number	ETBF2313C124E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Ischemia (1942); Rupture (2208); Thrombosis/Thrombus (4440)
Date of Event	02/22/2023
Type of Reportable Event	Death
Event or Problem Description
An endurant ii bifurcate stent graft system was implanted in the endovascular treatment of a 53mm saccular aaa.  it was reported during the procedure, after implanting the main body and a limb, the physician began very lightly ballooning the proximal neck seal zone. while ballooning there was a change in diameter of the proximal neck and a rupture was confirmed.The patients blood pressure dropped and sustained balloon inflation was used to maintain systolic pressure.The physician  then obtained left arm access and used a chimney technique to place a non mdt stent into the left renal artery and subsequently placed a 25/25/49 aortic cuff to the level of the right renal artery.  after ballooning,  the cuff helped slow the extravasation in the proximal neck but the patient continued to be unstable and the patient was  converted to an open surgical repair.  per the physician the cause of the rupture was due to very friable and calcified tissue in the proximal seal zone.No additional clinical sequalae were 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
Film analysis the reported aortic rupture was confirmed; however, the cause of the event could not be fully determined from the still images provided.Lack of procedural angiogram videos showing the exact moment of ballooning and vessel rupture did not allow for a thorough assessment of the event.Although the cause of the event cannot be determined, the anatomical characteristics reported to have been a factor in the aortic rupture (i.E.Calcification) during ballooning were observed on the films.The cause of death could not be assessed.Analysis of the returned films did not reveal and obvious out of specification stent graft integrity issues.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
B5; additional information received : it was reported after the patient was converted to open repair, the physicians explanted the cuff and the bifurcated graft except for the limbs, the physicians cut off the limbs distal to the flow divider and sewed a aorto bi-fem graft into the existing endograft limbs.The physician removed the non mdt stent from the left renal artery and the implanted both renal arteries.The patient survived the open repair but expired the following day due to complications.It was said the patients sma became thrombosed and the patient developed a necrotic bowel which led to her expiration.It was confirmed it was a reliant balloon used during the index procedure.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: 16442062
• Report Number: 9612164-2023-00862
• Device Sequence Number: 20233887
• Product Code: MIH
• UDI-Device Identifier: 00613994991164
• UDI-Public: 00613994991164
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 03/24/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/15/2023
• Device Model Number: ETBF2313C124E
• Device Catalogue Number: ETBF2313C124E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2023
• Supplement Date Received by Manufacturer: 03/09/2023; 03/10/2023
• Initial Report FDA Received Date: 02/27/2023
• Supplement Report FDA Received Date: 03/09/2023; 03/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2021
• 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; Death
• Patient Age: 84 YR
• Patient Sex: Female