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

Model Number	SA-85
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/14/2020
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
An endurant ii stent graft system was implanted in a patient for the endovascular treatment of a 59mm abdominal aortic aneurysm on (b)(6) 2018.A non-mdt balloon expandable stent was also used during the procedure.An endurant cuff and 3 endoanchors were also implanted during this procedure.It was reported that the patient expired on the (b)(6) 2020 due to an unknown reason.The patient had a asymptomatic type ii endoleak diagnosed a year previously which was unresolved.The site has said the cause of death was unknown and the patient did not expire at the hospital.The sponsor assessed the death as not related to the procedure and possibly related to the study device (endoanchor).It was said the sponsor assessment was believed to be conservative especially when the cause of death is unknown.No additional clinical sequalae were provided and the patient is expired.

• 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
• MDR Report Key: 11271340
• Report Number: 9612164-2021-00462
• Device Sequence Number: 16996382
• Product Code: OTD
• UDI-Device Identifier: 00763000006617
• UDI-Public: 00763000006617
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K140036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/03/2021

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: 09/13/2019
• Device Model Number: SA-85
• Device Catalogue Number: SA-85
• Device Lot Number: 0008794020
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2021
• Initial Report FDA Received Date: 02/03/2021
• 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 Age: 73 YR
• Patient Weight: 100