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

Model Number	SA-85
Medical Device Problem Codes	Fracture (1260); Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A heli-fx endoanchoring system (0011580490) was used prophylactically with an endurant stent graft for a hostile aortic neck.It was reported during the procedure, the heli-fx applier was unable to fully load the endoanchor.A new heli-fx applier was used as a replacement and treatment was successfully completed.5-6 endoanchors had been implanted before the applier stopped working.It was reported that last endoanchor was successfully deployed and securely implanted in the vessel wall.There was no damage to the applier or packaging before use.The applier did not display any error lights.Per the physician the difficulty loading the endoanchor was device related.No additional clinical sequelae were reported, and the patient is fine.Device analysis showed a fractured endoanchor inside the applier housing.The site were unable to confirm if the endoanchor fracture occurred outside the patient but did confirm that the last endoanchor was successfully deployed and securely implanted in the vessel wall.
Additional Manufacturer Narrative
Device evaluation summary: there was no deformation evident to the applier.A fragment of a fractured endoanchor was visible in the applier 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 8.77v.The battery was reattached, 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): oax05 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, and the motor rotated however, the fragment of the fractured endoanchor was not deployed.Attempts to remove the fragment manually were unsuccessful.As the fragment of fractured endoanchor remained in the applier housing new endoanchor could not be loaded to confirm device functionality.The reported error message display was confirmed through analysis.An image was received showing a partially loaded endoanchor in the applier housing with the forward arrow light on.The reported inability to load the endoanchor was confirmed through image review.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
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: 19002693
• Report Number: 9612164-2024-01516
• Device Sequence Number: 20957731
• Product Code: OTD
• UDI-Device Identifier: 00763000645113
• UDI-Public: (01)00763000645113(17)250108(10)0011580490
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K140036
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2026

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: 01/08/2025
• Device Model Number: SA-85
• Device Catalogue Number: SA-85
• Device Lot Number: 0011580490
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2024
• Supplement Date Received by Manufacturer: 05/26/2026
• Initial Report FDA Received Date: 03/29/2024
• Supplement Report FDA Received Date: 05/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2023
• 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 Sex: Unknown