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 Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/21/2017
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
An endurant ii stent graft system was implanted in a patient for the endovascular treatment of an abdominal aortic aneurysm.It was reported that after the stent graft was implanted there was a type ia endoleak.The decision was made to use endoanchors.The radiopaque marker on guide came off after second endoanchor deployment.Per the physician the cause of the event is device related.Per the physician, the cause of the endoleak was due to the patient anatomy of a short conical proximal aortic neck.The endoleak was found to have resolved.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Device evaluation summary: upon inspection of the guide, the tip of the guide was oval and the inner liner was delaminated with exposed braid wires.The was deformation approximately 4mm from the tip of the guide.The pebax was folded over in places and appears to be tucked under the support ring where the support ring is exposed.The rest of the device was unremarkable.The knob was rotated and the guide deflected normally.It was noted that the more the guide was deflected, the more the tip became ovalized causing the support ring to become more displaced.The pbax was pulled away from the tip and found that the kevlar cord was not routed around the support ring.The kevlar cord was pulled and the entire length of the kevlar cord was easily removed from the device.The entire length of the kevlar cord was bloodied.The reported complaint could not be confirmed as the ro marker and support ring were still within the returned heli-fx guide.The device was returned with the support ring slightly dislodged.The cause of the support ring to dislodge after the second deployment cannot conclusively be determined from the device analysis as the event occurred in-vivo and could not be replicated.Similar events have found that if insertion difficulty is met at the tip of the guide, the user may attempt to forcefully push the applier hard enough causing the guide tip to become dislodged.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 dr; sunnyvale CA 94089
• MDR Report Key: 6793666
• Report Number: 2953200-2017-01283
• Device Sequence Number: 19275483
• 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): 09/13/2017

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: 01/31/2019
• Device Model Number: HG-16-62-28
• Device Catalogue Number: HG-16-62-28
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2017
• Initial Date Received by Manufacturer: 07/21/2017
• Supplement Date Received by Manufacturer: 09/13/2017
• Initial Report FDA Received Date: 08/15/2017
• Supplement Report FDA Received Date: 10/10/2017
• 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: 74 YR