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

Model Number	SA-85
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	03/09/2026
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 endovascular aortic repair case using the heli-fx endosystem prophylactically with a non mdt endo-graft.The aorta diameter at the renal artery was 29-30mm and the proximal aortic neck length was 15mm at implant.The vessel was not tortuous and had no calcification at implant.It was reported during the index procedure one endoanchor became dislodged from the endograft and embolized into the right renal artery.An attempt was made to recover the endoanchor with an en-snare, but this was unsuccessful.The endoanchor remains in the renal artery, and the patient has not received any further treatment.A 30-day computed tomography is planned to determine any adverse events.No patient complications have been reported as a result of this event.The cause of the dislodgement is undetermined.No additional clinical sequelae were reported and the patient will be monitored.
Additional Manufacturer Narrative
D4: updated additional information received: it was confirmed that 3 endoanchors were successfully implanted before the 4th endoanchor dislodged.It was verified under fluoroscopy that the4th endoanchor penetrated through the endograft which is why the physician proceeded with the deployment.No warning lights illuminated on the applier before or when the dislodgement occurred.According to the physician, there was no resistance when pulling the device back that led to the dislodgement and it felt like the previous deployments.The ifu was followed during deployment.It was not thought that the heli-fx guide contributed to the dislodgement.The patient status was reported as recovering nicely.It was reported that the endoanchor penetrated the graft; and noted that it is very difficult to verify if the endoanchor penetrated the vessel.The endoanchor was placed in the proximal seal of the main body which was well opposed to the aortic neck and assumed that the endoanchor penetrated the vessel.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: 24589108
• Report Number: 9612164-2026-01319
• Device Sequence Number: 9385992
• Product Code: OTD
• UDI-Device Identifier: 00763000645113
• UDI-Public: (01)00763000645113(17)271222(10)0013205183
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 03/24/2026

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: 0013205183
• 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: 03/09/2026
• Supplement Date Received by Manufacturer: 03/14/2026
• Initial Report FDA Received Date: 03/13/2026
• Supplement Report FDA Received Date: 03/24/2026
• Date Device Manufactured: 12/22/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female