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

Model Number	SA-85
Medical Device Problem Codes	Malposition of Device (2616); Activation, Positioning or Separation Problem (2906); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/13/2026
Type of Reportable Event	Serious Injury
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
It was reported that during an index endovascular procedure to treat a 45 mm abdominal aortic aneurysm, an endurant ii/iis stent graft system (esbf3214c103e with etlw1616c93e and etlw1620c93e) was implanted successfully and endo-anchors were then deployed.Five endo-anchors were implanted successfully; however, during deployment of the sixth endo-anchor, the anchor was reported to not be engaged with the graft fabric or arterial wall when deployed.The endo-anchor migrated above the suprarenal stents of esbf3214c103e.The physician removed the endo-anchor delivery system, inserted the dilator of a 16 fr sheath, and advanced the 16 fr sheath proximal to the suprarenal stents of esbf3214c103e over a stiff 0.035-inch guidewire, then removed the dilator.A goose-neck style snare was inserted to attempt to snare the unfixed endo-anchor.During this maneuver the 16 fr sheath and snare were pulled down into the graft, after which the snare became tangled with the suprarenal stents of esbf3214c103e.The physician attempted unsuccessfully to free the snare and then converted to an open surgical repair of the abdominal aneurysm.The esbf3214c103e, etlw1616c93e, etlw1620c93e, and sa-85 endo-anchors were explanted and replaced with a surgical aortic graft from another manufacturer.The physician attributed the event to user error.The patient was reported alive with no injury and no symptoms or complications.
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.

• 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: 24881348
• Report Number: 9612164-2026-01950
• Device Sequence Number: 9851822
• Product Code: OTD
• UDI-Device Identifier: 00763000645113
• UDI-Public: (01)00763000645113(17)271202(10)0013149254
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K140036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• 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): 06/09/2026

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 Model Number: SA-85
• Device Catalogue Number: SA-85
• Device Lot Number: 0013149254
• 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: 04/13/2026
• Supplement Date Received by Manufacturer: 06/09/2026
• Initial Report FDA Received Date: 04/15/2026
• Supplement Report FDA Received Date: 06/09/2026
• Date Device Manufactured: 12/02/2025
• 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 H11...
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male