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	09/19/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Heli-fx aptus endoanchors were implanted in a patient for the treatment for prevention of aortic neck dilatation in another manufacturer¿s stent graft.It was reported the final angiogram revealed a proximal type i endoleak, a low-flow proximal type i endoleak.There was no intervention performed and the proximal type i endoleak was unresolved.Per the investigator the implantation of the heli-fx aptus endoanchors was not successful.The investigator indicated the cause of the event was related to the aaa.No additional clinical sequelae were reported and the patient will be monitored by the 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: 6968579
• Report Number: 2953200-2017-01614
• Device Sequence Number: 1091586
• Product Code: OTD
• UDI-Device Identifier: 00763000006624
• UDI-Public: 00763000006624
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 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: 10/31/2018
• Device Model Number: SA-85
• Device Catalogue Number: SA-85
• Device Lot Number: 50053016
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/27/2017
• Supplement Date Received by Manufacturer: 11/15/2017
• Initial Report FDA Received Date: 10/23/2017
• Supplement 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
• Patient Age: 70 YR
• Patient Weight: 77