MAUDE Adverse Event Report: MEDTRONIC IRELAND ENDO ANCHOR SYSTEM - HELI-FX AAA; ENDOVASCULAR SUTURING SYSTEM

Model Number	SA-85
Medical Device Problem Codes	Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Embolism (1829)
Date of Event	10/19/2017
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
A heli-fx applier was used to treat a type 1a endoleak from another manufacturer's stent graft.It was reported that the physician successfully deployed two endoanchors.At this point the blue error light was blinking.The physician had pushed the applier into the deflected guide catheter very hard, and that they believed this may have caused the issue.Later on in the procedure, a bubble was noted in the aorta, which was removed with a 2 catheter by the physician.Per the physician the cause of the event was user error.A new applier was used to complete the procedure.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Device evaluation summary: the error light event was confirmed; the applier experienced an error during the procedure due to a drive motor operation time out failure.The root cause of the event could not be determined, as the device was reset and functioned as expected during analysis.It is possible the corrosion to the connector pins and motor may have caused shorts within the applier resulting in an error light during the procedure.The cause of the emboli could not be confirmed as the event occurred in vivo and could not be replicated during device analysis.Previous testing of heli-fx guide devices confirmed it is possible to create a vacuum.Drawing air through the proximal device seals if the tip of the guide is flush/compressed against the stent graft wall (more probable in cases where the guide deflection length = neck diameter) and the applier is removed quickly.Guidance for preventing this is included in the ifu.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: 7023893
• Report Number: 2953200-2017-01748
• Device Sequence Number: 19076917
• Product Code: OTD
• UDI-Device Identifier: 00643169647695
• UDI-Public: 00643169647695
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2018
• Device Model Number: SA-85
• Device Catalogue Number: SA-85
• Device Lot Number: 50102075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2017
• Initial Date Received by Manufacturer: 10/19/2017
• Supplement Date Received by Manufacturer: 12/18/2017
• Initial Report FDA Received Date: 11/13/2017
• Supplement Report FDA Received Date: 01/04/2018
• 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