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

Model Number	ETTF3636C70E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
An endurant iis stent graft was implanted during the endovascular treatment of a 55mm abdominal aortic aneurysm on (b)(6) 2022.It was reported that, during the index procedure, post deployment imaging revealed type ia endoleak.The endoleak was addressed by placing a 36/49 proximal cuff and 7 helifx endoanchors in the proximal neck area.It was reported approximately 6 weeks post the index procedure follow up ct showed a type ia endoleak.The patient then presented emergently symptomatic of the type ia endoleak.The aneurysm measured 60mm.Intervention was then performed on the same date.As the only treatment option the physician then implanted an endurant extension cuff ettf3636c70e and an additional 6 endoanchors.The type ia endoleak improved but there was still late filling observed.The physician was hopeful that upon reversal of the patients heparin the type ia would resolve.The cause of the endoleak is believed to be disease progression of the proximal neck.Per physician, it is believed that the anatomy contributed to the type ia endoleak due to the short and wide proximal landing zone.No additional clinical sequelae were provided, and the patient is fine.
Additional Manufacturer Narrative
Film evaluation summary: the reported type ia endoleak was confirmed on the ct¿s received; however, the exact cause of the type ia endoleak could not be fully determined.Earlier post-implant films were not provided for comparison or for review of the reported disease progression over time.Angiograms (including endoleak interrogation) could allow for a more comprehensive determination of the endoleak cause, but these were not provided.It is likely that disease progression, as reported and the patients angulated aortic neck were a factor in the ia endoleak.Concomitant type ii endoleaks from collateral vessels surrounding the aneurysm sac, also could not be ruled out.Analysis of the returned films did not reveal any obvious stent graft integrity issues.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: ENDURANT II EXTENSION CUFF
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• 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: 19482830
• Report Number: 9612164-2024-02715
• Device Sequence Number: 18145354
• Product Code: MIH
• UDI-Device Identifier: 00613994991515
• UDI-Public: 00613994991515
• 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: 2024
• 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): 07/02/2024

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: 01/22/2026
• Device Model Number: ETTF3636C70E
• Device Catalogue Number: ETTF3636C70E
• 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: 05/15/2024
• Supplement Date Received by Manufacturer: 06/07/2024
• Initial Report FDA Received Date: 06/07/2024
• Supplement Report FDA Received Date: 07/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2024
• 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: 81 YR
• Patient Sex: Male