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U.S. Department of Health and Human Services

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

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GE MEDICAL SYSTEMS SCS ADVANCE VESSEL ANALYSIS II TAVI ANALYSIS FOR CT Back to Search Results
Device Problem Improper or Incorrect Procedure or Method
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.

 
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Brand NameADVANCE VESSEL ANALYSIS II
Type of DeviceTAVI ANALYSIS FOR CT
Manufacturer (Section D)
GE MEDICAL SYSTEMS SCS
283 rue de la miniere
buc 78530
FR  78530
Manufacturer Contact
michele marousek
500 west monroe
chicago , IL 
MDR Report Key8052674
Report Number9611343-2018-00005
Device Sequence Number1
Product CodeLLZ
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 Received11/08/2018
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
Event Location No Information
Date Manufacturer Received12/05/2018
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured12/06/2016
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 11/08/2018 Patient Sequence Number: 1
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