MAUDE Adverse Event Report: MEDTRONIC SUNNYVALE/APTUS ENDOSYSTEMS ENDO ANCHOR SYSTEM - HELI-FX AAA; ENDOVASCULAR SUTURING SYSTEM

Model Number	HG-16-62-28
Medical Device Problem Codes	Kinked (1339); Positioning Problem (3009)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A heli-fx guide was used as an accessory device with a valiant stent graft system for the endovascular treatment an unknown aortic disease as prophylactic.It was reported that as the physician was attempting to deflect the tip of the guide and position it against the wall of the stent/aorta it was not possible to advance the applier in order to place endoanchor.It appeared that the teflon tape on the distal part of guide was kinked.The physician removed the guide and that is what appeared to have happened.Another 28mm guide was used to successfully place 6 endoanchors.Per the physician the cause of the event was device related.No 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 SUNNYVALE/APTUS ENDOSYSTEMS; 271 gibraltar drive; sunnyvale CA 94089
• MDR Report Key: 6612805
• Report Number: 2953200-2017-00922
• Device Sequence Number: 18833956
• Product Code: OTD
• UDI-Device Identifier: 00643169647626
• UDI-Public: 00643169647626
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K140036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2017

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: 04/30/2018
• Device Model Number: HG-16-62-28
• Device Catalogue Number: HG-16-62-28
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/11/2017
• Supplement Date Received by Manufacturer: 05/11/2017
• Initial Report FDA Received Date: 06/05/2017
• Supplement Report FDA Received Date: 10/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR