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

Model Number	HG-18-90-42
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A heli-fx applier was intended for use as an accessory device with a valiant navion stent graft as a prophylactic endovascular treatment.  it was reported that during the index procedure, the applier could not advance through the heli-fx guide, because the radiopaque band on the tip of guide had detached and was obstructing the guide lumen.An additional heli-fx guide was used to complete the procedure.The cause of the event is unknown.No clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Additional information received; it was reported that the difficulties were experienced on first advancing the applier through the guide before the implant of any endoanchors.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Device evaluation summary the guide was returned for analysis.Deformation was visible to the inner curve of the guide tip.The tip deflected on rotation of the control knob.Material delamination was visible inside the tip.Deformation of the c-marker and braid wire was observed inside the tip.Fluoroscope imaging confirmed the c-marker has moved from its original position in the tip.The reported event was confirmed through analysis.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDO ANCHOR SYSTEM - HELI-FX TAA
• Common Device Name: ENDOVASCULAR SUTURING SYSTEM
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 8735064
• Report Number: 9612164-2019-02535
• Device Sequence Number: 2572784
• Product Code: OTD
• UDI-Device Identifier: 00763000025298
• UDI-Public: 00763000025298
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P990020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/26/2019

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: 02/03/2021
• Device Model Number: HG-18-90-42
• Device Catalogue Number: HG-18-90-42
• Device Lot Number: 0009574641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2019
• Initial Date Received by Manufacturer: 06/19/2019
• Supplement Date Received by Manufacturer: 07/31/2019; 09/25/2019
• Initial Report FDA Received Date: 06/26/2019
• Supplement Report FDA Received Date: 08/22/2019; 09/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1