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

Model Number	SG-64
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Date of Event	03/14/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A heli-fx applier and endoanchors and endurant aortic cuff were used in the endovascular treatment of the patient.The maximum diameter of the aneurysm was 54.4mm.It was reported that the patient had an aneurx main body and aneurx iliac extension cuffs implanted approximately 14.5 years before.The maximum diameter of the aneurysm was 54.4mm.It was reported that during the intervention, 4 endoanchors were implanted in the main body at the proximal neck.It was noted that the patient expired approximately 2 years post intervention from an unknown cause.Relationship between the patient death and the study device or procedure was not reported.No additional clinical sequelae were reported.

• 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: 7435558
• Report Number: 2953200-2018-00558
• Device Sequence Number: 1314148
• Product Code: OTD
• UDI-Device Identifier: 00643169647572
• UDI-Public: 00643169647572
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K140036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/17/2018

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: 11/30/2017
• Device Model Number: SG-64
• Device Catalogue Number: SG-64
• Device Lot Number: 49619040
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2018
• Initial Report FDA Received Date: 04/17/2018
• 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: Death
• Patient Weight: 87