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	11/13/2017
Type of Reportable Event	Malfunction
Event or Problem Description
An endurant iis stent graft system was implanted in a patient for the endovascular treatment of a 68mm diameter abdominal aortic aneurysm.It was reported that during the index procedure, on the final angiogram, a proximal type i endoleak was noticed.The physician ballooned again and placed 9 endoanchors to resolve the leak.Another angio was performed, but the type 1 endoleak was still present.The physician elected to stop the procedure.It was reported that the left renal artery was the lowest renal artery and the proximal edge of the stent graft was at that level.Due to the angle that the stent graft was implanted proximally, the right side of the stent graft had landed distal to the right renal artery, which was 5mm more proximal.The physician determined that by placing a proximal cuff, it would still probably land the exact same way and so decided not to place one as there was no available landing zone at the left renal artery.The physician has not determined when or if any intervention will be performed.It was reported that, as per the physician, the cause of the event was anatomy, due to the short and conical proximal aortic neck measuring 29-33 mm in diameter and 11mm in length.There was also angulation of approximately 30 degrees.No additional clinical sequelae were reported and the patient will be monitored by their physician.

• 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: 7074017
• Report Number: 2953200-2017-01893
• Device Sequence Number: 927552
• Product Code: OTD
• UDI-Device Identifier: 00643169647695
• UDI-Public: 00643169647695
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/01/2017

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: 02/28/2018
• Device Model Number: SA-85
• Device Catalogue Number: SA-85
• Device Lot Number: 49816008
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2017
• Initial Report FDA Received Date: 12/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1