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

Model Number	SA-85
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	08/23/2017
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 endo anchoring system was used as an accessory device for the endovascular treatment of a type ia endoleak in a previously implanted endologix stent graft system (implanted 6 years previously).Aaa diameter measured 60mm with a proximal neck angulation of 20 degrees.50% thrombus at seal zone and 10% calcium at seal zone.During the procedure, it was reported that 8 endoanchors were implanted along with a non-mdt excluder iliac branch excluder internal iliac devices.At the end of the procedure it was reported that there was a persistent type ia endoleak present.No additional clinical sequelae were reported and the patient will be monitored by their physician.
Additional Manufacturer Narrative
Failure to follow instruction for use of heli-fx endoanchors with non medtronic stent graft bifurcate device listed as not compatible in ifu.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information received reported that on the (b)(6) 2018 a ct scan identified a type ia endoleak.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
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported by the investigator the endoleak noted on ct may be a type ii endoleak located at the lumbar artery.

• 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: 7717627
• Report Number: 2953200-2018-01099
• Device Sequence Number: 904025
• 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,Followup,Followup,Followup
• Report Date (Section B): 10/31/2018

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: 06/27/2018; 08/15/2018; 08/08/2018; 10/18/2018
• Initial Report FDA Received Date: 07/25/2018
• Supplement Report FDA Received Date: 08/21/2018; 09/10/2018; 10/02/2018; 10/31/2018
• 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