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); Device Displays Incorrect Message (2591); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: the applier shaft was wavey.An endoanchor was visible partially loaded on 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 8.64v.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): oax02 multiple application events poster per cycle, 0bx0f fwd pause, 0cx08 key pressed and released flags both active, 0dx0f fwd pause.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 endoanchor was deployed.The backlight was flashing; an endoanchor was successfully loaded and deployed confirming the applier functionality.The endoanchor returned in the applier appeared slightly deformed when compared to the newly deployed endoanchor.The reported error display was confirmed based on the analysis.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
An endurant stent graft cuff was implanted during the endovascular treatment of an abdominal aortic aneurysm.It was also reported that the patient had a previously implanted stent graft prior to the implantation of the endurant cuff.It was reported during the index procedure, a type ia endoleak was identified.Intervention was performed to treat the endoleak where two heli-fx endoanchors were successfully deployed.However, the applier stopped working and a replacement heli-fx applier was used to complete the deployment of the endoanchors.The endo anchors did not immediately fix the type 1a.However, the physician expected that that once heparin wore off that it would seal.Per the physician the cause type ia endoleak is undetermined.No additional clinical sequelae were reported, and the patient is fine.
Additional Manufacturer Narrative
B5; additional information received: the cause of the ia endoleak is unknown.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: 20568865
• Report Number: 9612164-2024-04988
• Device Sequence Number: 18012735
• Product Code: OTD
• UDI-Device Identifier: 00763000645113
• UDI-Public: 00763000645113
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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): 01/06/2025

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: 03/06/2026
• Device Model Number: SA-85
• Device Catalogue Number: SA-85
• Device Lot Number: 0012176436
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2024
• Supplement Date Received by Manufacturer: 01/06/2025
• Initial Report FDA Received Date: 10/30/2024
• Supplement Report FDA Received Date: 01/06/2025
• Date Device Manufactured: 03/06/2024
• 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: 86 YR
• Patient Sex: Male