MAUDE Adverse Event Report: MEDTRONIC CARDIOVASCULAR SANTA ROSA 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	07/08/2016
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
Heli-fx endoanchors was selected as an accessory device for the endovascular treatment of a proximal type i endoleak from another manufacturer¿s stent graft.It was reported that 4 endoanchors were implanted in the proximal neck of the main body of the endograft due to concern for late failure of the devices.However, it was reported that approximately 40 days post index procedure, an unidentified endoleak was noted.It was noted that ¿during procedure, after placement of endoanchors, operating surgeon noticed a small unidentified endoleak¿.No treatment was given, and the patient recovered without treatment.It was noted that the event was not related to the device or procedure.

• Brand Name: ENDO ANCHOR SYSTEM - HELI-FX AAA
• Common Device Name: ENDOVASCULAR SUTURING SYSTEM
• Manufacturer (Section D): MEDTRONIC CARDIOVASCULAR SANTA ROSA; 3576 unocal place; santa rosa CA 95403
• MDR Report Key: 7099260
• Report Number: 2953200-2017-01936
• Device Sequence Number: 781054
• Product Code: OTD
• UDI-Device Identifier: 00643169647695
• UDI-Public: 00643169647695
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/08/2017

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: 05/31/2018
• Device Model Number: SA-85
• Device Catalogue Number: SA-85
• Device Lot Number: 49918045
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2017
• Initial Report FDA Received Date: 12/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 86 YR
• Patient Weight: 66