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	Pain (1994)
Date of Event	07/05/2018
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
An endurant ii bifurcated stent graft and endoanchors were implanted in patient for the endovascular treatment of a 55 mm abdominal aortic aneurysm.The endoanchors were implanted for the prevention of neck dilation.No type ia endoleak was noted after implantation of the last endoanchor.Approximately three weeks later the endoleak was confirmed as a type ia endoleak on ct after the patient presented emergently with increasing back and chest pain.The aneurysm was shown to be 60 mm and the patient underwent an intervention procedure using coils and onxy to resolve the endoleak.The event was assessed by the investigator to be related to the index procedure.No additional clinical sequelae were reported and the patient is fine.
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: 8743594
• Report Number: 9612164-2019-02582
• Device Sequence Number: 2040069
• Product Code: OTD
• UDI-Device Identifier: 00763000006617
• UDI-Public: 00763000006617
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K140036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/26/2020
• Device Model Number: SA-85
• Device Catalogue Number: SA-85
• Device Lot Number: 0009010631
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/03/2019
• Supplement Date Received by Manufacturer: 08/22/2019
• Initial Report FDA Received Date: 06/28/2019
• Supplement Report FDA Received Date: 08/22/2019
• 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: 76 YR
• Patient Weight: 69