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 Codes	Low Blood Pressure/ Hypotension (1914); Confusion/ Disorientation (2553)
Date of Event	06/05/2017
Type of Reportable Event	Serious Injury
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 the patient to prevent late failure of the endurant stent graft used in the treatment of a 46mm aaa.There was a proximal neck angulation of 10 degrees and a suprarenal neck angulation of 10 degrees.30 percent of the proximal aortic seal zone circumference had localized thrombus that measured 8 mm thick.There was no calcium at the seal zone.It was reported that, during the index procedure, a proximal type i endoleak was observed after the endurant stent graft was implanted.The physician elected to implant 5 endoanchors in the proximal neck of the main body stent graft.The endoleak was resolved and the procedure was successfully completed.It was reported that post procedure, the patient suffered hypotension and this was deemed probably related to the procedure but not to the device.This resolved on the same date after administration of iv fluids.It was reported that on the next day, the patient suffered confusion.This was deemed to be possibly related to the procedure but not to the device.This resolved on the same day without treatment.

• 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: 7016907
• Report Number: 2953200-2017-01741
• Device Sequence Number: 11014467
• Product Code: OTD
• UDI-Device Identifier: 00643169647695
• UDI-Public: 00643169647695
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 11/10/2017

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: 10/31/2018
• Device Model Number: SA-85
• Device Catalogue Number: SA-85
• Device Lot Number: 50068098
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2017
• Initial Report FDA Received Date: 11/10/2017
• 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: Required Intervention
• Patient Age: 83 YR
• Patient Weight: 76