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

Model Number	HG-16-62-28
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	05/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: other relevant device(s) are: sa-85; lot number: unknown; use by date: unknown; upn#: unknown.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A heli-fx endoanchor system was used as an accessory device for an unknown endovascular treatment with a non-mdt stent graft system.The cook stent graft had been previously implanted approximately 8 years earlier and endoanchors were being implanted to fix migration and an unknown type endoleak.During the endoanchor procedure a distal cook zenith stent graft, a viabahn stent graft and another proximal stent graft were implanted and 5 endoanchors were implanted in the distal neck as part of the planned procedure.Two weeks after the endoanchor index procedure, it was reported the patient suffered from an infected groin.The event was treated with medication and another surgical procedure.The event resolved 3 weeks later.The event has been assessed as related to the index procedure.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDO ANCHOR SYSTEM - HELI-FX AAA
• Common Device Name: ENDOVASCULAR SUTURING SYSTEM
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 7663257
• Report Number: 2953200-2018-00964
• Device Sequence Number: 2527506
• Product Code: OTD
• UDI-Device Identifier: 00763000025267
• UDI-Public: 00763000025267
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K140036
• 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
• Report Date (Section B): 10/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/26/2020
• Device Model Number: HG-16-62-28
• Device Catalogue Number: HG-16-62-28
• Device Lot Number: 0008970828
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/13/2018
• Supplement Date Received by Manufacturer: 10/19/2018
• Initial Report FDA Received Date: 07/05/2018
• Supplement Report FDA Received Date: 10/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Weight: 74