MAUDE Adverse Event Report: GE MEDICAL SYSTEMS SCS ADVANCE VESSEL ANALYSIS II; TAVI ANALYSIS FOR CT

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Aortic Valve Stenosis (1717); Stenosis (2263)

Event Date 08/01/2018

Event Type  Injury  

Manufacturer Narrative

Patient information could not be obtained due to country privacy laws.Udi not required.The initial reporter is located outside the usa, and therefore this information is not provided due to country privacy laws.Device evaluation initiated, yet not completed at this time.

Event Description

Annulus measurement was performed by a radiologist with assistance of advantage workstation tavi (transcatheter aortic valve replacement) software on a patient ct scan obtained (b)(6) 2018.A tavi valve implantation procedure was performed on (b)(6) 2018 where a medtronic evolute pro 29mm was placed, based on radiologist measurement of 465.4 mm2.Severe periprosthetic vascular insufficiency was identified following valve placement.A tavi valve in valve procedure was then performed in (b)() 2018 following the same radiologist measurement of annulus using a more recent ct image and different method that resulted in a measurement of 547 mm2, where an edwards sapien3 29mm valve was placed with normal post implant outcome.

Manufacturer Narrative

Additional manufacturer narrative - event problem evaluation codes added.Investigation completed.Root cause was determined to be a use error.No product defect identified.The root cause was identified that the annulus plane was manually placed by the user at the incorrect location which resulted in an underestimation of the valve needed.The software guides the user to review and adjust the plane and allow the verification on the plane as follows: the default layout is multiple oblique views of longitudinal and perpendicular orientations.The plane adjustment tool is opened by default at the loading of the application.Once the user has set the annulus plane, this plane is displayed as a permanent segment on all viewports, oblique views and 3d views.The operator manual informs the user on the need to adjust the annulus plane and provide instructions.The user is also informed on the need to use an optimal fov (field of view) before performing any measurement.On-site tavi training was conducted april 9 and april 12, 2018.Following the receipt of this event, on-site re-training was conducted on october 28, 2018.The investigation reaffirmed that the software measurements function properly and that the software risk control mitigations are working properly.There is no corrective action or changes to product design required.

• Brand Name: ADVANCE VESSEL ANALYSIS II
• Type of Device: TAVI ANALYSIS FOR CT
• Manufacturer (Section D): GE MEDICAL SYSTEMS SCS; 283 rue de la miniere; buc 78530 ; FR 78530
• MDR Report Key: 8052674
• MDR Text Key: 126634824
• Report Number: 9611343-2018-00005
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• PMA/PMN Number: K060779
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 12/17/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other