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

Model Number	SA-85
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/16/2019
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
An endurant iis stent graft system was implanted in a patient for the endovascular treatment of a 50 mm diameter abdominal aortic aneurysm.The aortic neck length was 15 mm and the diameter ranged from 26-30 mm.Mild proximal neck calcification was present.There was a highly angulated aortic neck.It was reported that during the index procedure, a type ia endoleak was noted on the completion angiogram.It was reported that the stent graft was in a good proximal position, so the physician decided to implant endoanchors.During the first attempt to deflect and orient the heli-fx guide, the device lost its ability to deflect.The physician then removed the guide and replaced it with another heli-fx device of same size.The physician was then able to place 6 endoanchors.Another angiogram demonstrated a reduced type ia endoleak.The physician then decided to end the procedure.As per the physician, the cause of the type ia endoleak could not be determined.The cause of the heli-fx guide issue was stated to be related to the patient's anatomy.It was noted that there was a highly angulated aortic neck created significant torque, causing the failure of the heli-fx guide.No additional clinical sequelae were reported and the patient is fine.

• 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: 8991572
• Report Number: 9612164-2019-03870
• Device Sequence Number: 304908
• Product Code: OTD
• UDI-Device Identifier: 00763000006617
• UDI-Public: 00763000006617
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K140036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/11/2019

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: 12/18/2020
• Device Model Number: SA-85
• Device Catalogue Number: SA-85
• Device Lot Number: 0009502487
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2019
• Initial Report FDA Received Date: 09/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 85 YR