MAUDE Adverse Event Report: Medtronic Ireland ENDO ANCHOR SYSTEM - HELI-FX AAA; ENDOVASCULAR SUTURING SYSTEM

Catalog Number	SA-85
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2026
Type of Reportable Event	Malfunction

• 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 ; +353(091)708096
• MDR Report Key: 50218471
• Report Number: 9612164-2026-04074
• Device Sequence Number: 18782659
• Product Code: OTD
• UDI-Device Identifier: 00763000645113
• UDI-Public: (01)00763000645113(17)280120(10)0013246423
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K140036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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
• Report Date (Section B): 08/12/2026

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 Catalogue Number: SA-85
• Device Lot Number: 0013246423
• 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: 08/03/2026
• Initial Report FDA Received Date: 08/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/20/2026
• 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: 76 YR
• Patient Sex: Female