MAUDE Adverse Event Report: MEDTRONIC IRELAND ENDO ANCHOR SYSTEM - HELI-FX AAA; ENDOVASCULAR SUTURING SYSTEM

Model Number	SA-85
Medical Device Problem Codes	Leak/Splash (1354); Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
An endurant iis stent graft was implanted during the endovascular treatment of a 77mm abdominal aortic aneurysm.The patient had a short, angled neck.It was noted that the length of the proximal aortic neck at implant was approx.6-16mm and proximal aortic neck diameter was noted as 29mm, both the left and right common iliac arteries had moderate vessel calcification.It was reported during the index procedure, esbf3614c103e was placed in the short angled neck.Ct imaging revealed a type ia endoleak.Endoanchors were implanted but failed to resolve the endoleak.Per the physician the cause of the type ia endoleak is anatomy related due to short angled neck.No additional clinical sequalae were provided and the patient will be monitored.
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.
Additional Manufacturer Narrative
Additional information received: it was clarified the aortic neck length was 6-10mm.The right renal artery was the lowest renal and due to the neck angle, the graft was not able to conform to the angle thus losing wall apposition on the greater curve below the left renal artery.The infrarenal neck angulation was reported to be within the ifu.The type ia endoleak was visualized on angiogram post graft deployment and post endoanchors placement.Five endoanchors were used but only one successfully attached the graft to the aortic neck.Endoanchors on the left side did not adhere the graft to aortic wall but penetrated the graft material.On the lesser curve below the right renal, 1 anchor did penetrate the graft and wall.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: ENDO ANCHOR SYSTEM - HELI-FX AAA
• Common Device Name: ENDOVASCULAR SUTURING SYSTEM
• 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: 18941899
• Report Number: 9612164-2024-01342
• Device Sequence Number: 2858040
• Product Code: OTD
• UDI-Device Identifier: 00763000645113
• UDI-Public: 00763000645113
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K140036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 04/02/2024

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: 06/25/2025
• Device Model Number: SA-85
• Device Catalogue Number: SA-85
• Device Lot Number: 0011840770
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2024
• Supplement Date Received by Manufacturer: 03/21/2024
• Initial Report FDA Received Date: 03/20/2024
• Supplement Report FDA Received Date: 04/02/2024
• Date Device Manufactured: 06/26/2023
• 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: 87 YR
• Patient Sex: Male