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	Death (1802)
Date of Event	03/21/2018
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 were used in conjunction with an endurant stent graft system in a patient for the endovascular treatment of a 76mm abdominal aortic aneurysm.It was reported that less than two years later the patient expired of a cause unknown at a rehab facility.It is unknown if a mdt device or procedure is related to the patient's death.No additional clinical sequalae were reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information received; it was reported that the cause of death was due to respiratory failure on the (b)(6) 2018.The respiratory failure was by assessed by the investigator and sponsor to not be related to device or procedure.The respiratory failure was due to septic shock, pneumonia-aspiration and dysphagia.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: 7921632
• Report Number: 2953200-2018-01363
• Device Sequence Number: 1683481
• Product Code: OTD
• UDI-Device Identifier: 00643169647695
• UDI-Public: 00643169647695
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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,Followup,Followup,Followup
• Report Date (Section B): 09/25/2019

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: 07/31/2017
• Device Model Number: SA-85
• Device Catalogue Number: SA-85
• Device Lot Number: 49382058
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/26/2018
• Supplement Date Received by Manufacturer: 12/18/2018; 07/24/2019; 09/20/2019
• Initial Report FDA Received Date: 10/01/2018
• Supplement Report FDA Received Date: 12/19/2018; 08/20/2019; 09/25/2019
• 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: 78 YR
• Patient Weight: 93