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

Model Number	ESBF2314C103E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Rupture (2208)
Date of Event	12/20/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: section d information references the main component of the system.Other relevant device(s) are: product id: e tlw1616c124e, serial/lot #: (b)(4), ubd: 27-oct-2023, udi#: (b)(4) ; product id: etlw1616c124e, serial/lot #: (b)(4), ubd: 28-mar-2024, udi#: (b)(4).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.
Event or Problem Description
An endurant iis bifurcate stent graft system was implanted in the endovascular treatment of a 51mm aaa.  it was reported that during the procedure, the stent grafts were implanted uneventfully.Due to a narrow distal aorta, pta balloons were used to open lumens.An angiogram was performed and an endoleak was present.The physician was unable to determine exact source of the leak.There was extravasation from the leak, and the patient became acutely hypotensive.A conformable balloon was used to occlude aorta and stabilize the  patient.Follow on angiograms were inconclusive, the leak persisted.A cuff was placed due to possible ia or type iv  endoleak.The patient continued to be unstable and the patient was converted to open repair.The bifurcate stent graft was suspected of containing the unknown endoleak but it is not known.It was confirmed the implant of the endurant cuff did not make any impact to the endoleak.The bifurcate and aortic cuff  were dissected below the m stent and sewed into a surgical graft.The other stent grafts were partially dissected and sewed into a surgical graft and removed.Per the physician the cause of the event could not be determined.  no additional clinical sequalae were provided and the patient is fine.
Additional Manufacturer Narrative
Product analysis 5 partial dissections of endurant stent grafts were returned for analysis.All sections had been cut transactionally and no whole limbs were returned.One of the partial limbs had been sewn into the bifurcate graft and could not be removed.Explant grafts were decontaminated with hydrogen peroxide and sodium hypochlorite pending further device testing to support the final product analysis findings.There was no damage found to any of the limbs and the cause of the endoleak could not be confirmed.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 IIS 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: 16156179
• Report Number: 9612164-2023-00178
• Device Sequence Number: 20595928
• Product Code: MIH
• UDI-Device Identifier: 00643169439993
• UDI-Public: 00643169439993
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 02/24/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/27/2023
• Device Model Number: ESBF2314C103E
• Device Catalogue Number: ESBF2314C103E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2022
• Supplement Date Received by Manufacturer: 01/31/2023
• Initial Report FDA Received Date: 01/13/2023
• Supplement Report FDA Received Date: 02/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: "SEE H10...."
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 74 YR
• Patient Sex: Male