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

Model Number	ETCF2525C49E
Medical Device Problem Codes	Leak/Splash (1354); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Aneurysm (1708); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: other relevant device(s) are: product id: e tlw1610c146e, serial/lot #: (b)(4, ubd: 18-nov-2022, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An endurant ii stent graft system was implanted in the endovascular treatment of a unknown sized abdominal aortic aneurysm.  it was reported that when the patient returned for follow-up approximately 9 months post the index procedure, an endoleak was noted on a cta.The patient is doing well with no symptoms.It was said it could be a type ib of the right iliac, possible type iii or a  possible type ii endoleak.  no cause was reported.  no additional clinical sequalae were provided and the patient will be monitored.
Additional Manufacturer Narrative
Product analysis: the reported endoleak was confirmed on the films provided; however, the cause and type of endoleak could not be fully determined.Lack of pre-implant ct's did not allow for a thorough assessment of the pre-implant anatomy.Endoleak interrogation via selective angiograms (injecting from different levels within the stent graft) to help determine the source and rule out other potential endoleak sources was not seen; thereby, making determination of the endoleak difficult.A type ib distal endoleak is unlikely as it appears that there was adequate distal seal.While a type ii endoleak cannot be ruled out, there was no obvious contrast leakage noted from collateral vessels.A type iii separation endoleak is unlikely to have occurred as contrast leakage was observed on a single layer portion of the endograft.This is most likely to have been a type iii fabric endoleak.Fabric wear due to external abrasion from the noted distal aortic calcification is a potential root cause.Additional information received: through completion of film analysis of ct's from 27-mar-2022 it was identified that the stent graft and contralateral limb extension implanted previous to the intervention performed on the 19-aug-2021 were most likely endurant devices.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; it was reported the patient had a prior stent graft implanted.However, it was not possible to confirm the brand and model of the original implant as the initial procedure was performed many years ago at a different facility.The type of endoleak is undetermined.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 EXTENSION CUFF
• 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: 14304903
• Report Number: 9612164-2022-01689
• Device Sequence Number: 20090269
• Product Code: MIH
• UDI-Device Identifier: 00613994991430
• UDI-Public: 00613994991430
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 06/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/11/2021
• Device Model Number: ETCF2525C49E
• Device Catalogue Number: ETCF2525C49E
• 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: 05/04/2022
• Supplement Date Received by Manufacturer: 05/04/2022; 06/09/2022
• Initial Report FDA Received Date: 05/06/2022
• Supplement Report FDA Received Date: 05/26/2022; 06/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2019
• 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...."
• Patient Age: 81 YR
• Patient Sex: Male