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 Code	Insufficient Information (4580)
Date of Event	08/04/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product analysis conclusion: the reported endoleak was confirmed on the videos provided, however, the cause and type of endoleak could not be conclusively determined.Lack of pre-implant cts did not allow for assessment of the pre-implant anatomy.Post-implant cts were also unavailable for review.Endoleak interrogation via selective angiograms (injecting from different levels within the stent graft) was partially performed and only a single imaging view point (a-p) was observed in the films provided; thereby, making determination of the endoleak difficult.Although a type iiib fabric endoleak due to a fabric tear cannot be ruled out since calcification was noted within the aneurysm sac, this type of endoleak is less likely to occur during the index procedure.There is a possibility that this a type ia proximal endoleak.Another possibility is the presence of a concomitant type iv endoleak due to graft porosity, potentially exacerbated by a reported active clotting time exceeding 350 during the procedure.Other factors such as heparin dose, outflow resistance, imaging quality, and volume of the aneurysm sac may have also contributed to this endoleak.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 stent graft system was implanted during the endovascular treatment of a 50mm + aaa.It was reported that during the index procedure there was an endoleak was observed at the final run.The physician re-ballooned the bifurcate using a reliant balloon and re-ran the final run however a persistent early endoleak was seen with aneurysm filling.The physician occluded the aorta by ballooning the bifurcate and took an angiogram via pigtail to determine the location of the endoleak.No endoleak was seen using this method.4 endoanchors were implanted in the bifurcate and another angiogram was done but the endoleak remained.Another 2 endoanchors from the same cassette were placed but the endoleak was still present.It was noted that the last act was over 350.The physician believes there is a tear in the endurant iis bifurcate stent graft.Per the physician the cause of the endoleak is undetermined.No additional clinical sequalae were provided and the patient will be monitored.

• 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: 17629979
• Report Number: 9612164-2023-03867
• Device Sequence Number: 20737537
• Product Code: MIH
• UDI-Device Identifier: 00643169439993
• UDI-Public: 00643169439993
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Report Date (Section B): 08/28/2023

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: 05/29/2025
• Device Model Number: ESBF2314C103E
• Device Catalogue Number: ESBF2314C103E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2023
• Initial Report FDA Received Date: 08/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/30/2023
• 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