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

Model Number	SA-85
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device analysis: there was no deformation evident to the applier.An endoanchor was visible partially loaded in the housing.The handle was opened, and no fluid or blood was observed within the handle.There were no loose connections or components observed.No corrosion was observed to the circuit board or connector pins.The battery was removed and measured 8.04v.A new battery was attached, and the unit powered up with the blue error light flashing, the forward light unresponsive and the back light flashing.The eprom was read and presented the following codes (locn x code): 0ax05 battery low detection, 0bx0e apply ready, 0cx07 drive motor operation time-out, 0dx17 fatal.The device was restarted in factory mode with the blue error light on, forward light flashing, back light on.The forward button was pressed; however, the motor did not rotate.The error and back lights were flashing.The protruding endoanchor was manually removed.A fragment of a fractured endoanchor was visible in the applier housing.It was not possible to manually remove the endoanchor fragment.The applier functionality could not be confirmed due to the error display.The reported inability to load an endoanchor was confirmed through analysis.Endoanchor fracture was confirmed.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 a prophylactic procedure to treat an abdominal aortic aneurysm, a malfunction occurred with a heli-fx ap plier.After successfully implanting three endoanchors, the fourth endoanchor failed to load fully into the applier was sticking out.The physician followed the instructions for use using the heli-fx applier.When an attempt was made to load another endoanchor, the same issue occurred.To resolve the issue, another applier was opened and used to complete the surgery.The procedure was completed as planned with the use of the new applier.No patient complications have been reported as a result of this event.

• 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: 21729094
• Report Number: 9612164-2025-01594
• Device Sequence Number: 3981301
• Product Code: OTD
• UDI-Device Identifier: 00763000645113
• UDI-Public: 00763000645113
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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
• Report Date (Section B): 03/31/2025

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: 04/17/2025
• Device Model Number: SA-85
• Device Catalogue Number: SA-85
• Device Lot Number: 0011738672
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2025
• Initial Report FDA Received Date: 03/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/18/2023
• 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
• Patient Age: 80 YR
• Patient Sex: Female