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

Model Number	SA-85
Health Effect - Clinical Codes	Aneurysm (1708); No Consequences Or Impact To Patient (2199)
Date of Event	10/12/2017
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
A heli-fx endoanchoring system was used as an accessory device in conjunction with non mdt extension limbs for the endovascular treatment of a type ia endoleak in a previously implanted non-mdt stent graft.It was noted that there was localized thrombus at the seal zone with 50% circumference (max thickness 17mm) and localized calcium of 10% (max thickness of 1mm).Eight endoanchors in total were implanted; however, the type ia endoleak was still present at the end of the procedure.It was reported that, approximately 2 months post procedure, during a follow up ct, two endoanchors were observed to have dislodged from the endograft and were not adequately penetrating the aortic wall.This was observed again during a follow up ct approximately 8 months post procedure along with a type ii endoleak.No action was taken as a result of these events.No additional clinical sequalae were reported and the patient will be monitored by their physician.
Additional Manufacturer Narrative
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: 7706053
• Report Number: 2953200-2018-01075
• Device Sequence Number: 1015819
• Product Code: OTD
• UDI-Device Identifier: 00643169647695
• UDI-Public: 00643169647695
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,Followup
• Report Date (Section B): 10/03/2018

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: 05/31/2019
• Device Model Number: SA-85
• Device Catalogue Number: SA-85
• Device Lot Number: 50207021
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/27/2018
• Supplement Date Received by Manufacturer: 08/08/2018
• Initial Report FDA Received Date: 07/20/2018
• Supplement Report FDA Received Date: 10/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Weight: 88