MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. ICT; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number 728306

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem Death (1802)

Event Type  Death  

Manufacturer Narrative

Note: we have not completed our investigation of this event.We will file a follow-up emdr at the completion of the investigation.Internal cross reference: complaint pr# (b)(4).

Event Description

This complaint has been evaluated based on the information provided.The customer reported that during a ct transaortic valve implant (tavi) scan, the scan did not complete and the reconstructed cardiac images were not as expected.The patient scans were used for tavi aortic valve planning.The patient expired in surgery during the placement of the aortic valve.This event has been determined to be a reportable event and is currently under investigation.

Manufacturer Narrative

The customer reported that during a ct trans aortic valve implant (tavi) scan, the scan did not complete as planned.The patient images were used for tavi aortic valve surgery planning and during the placement of the aortic valve in surgery the patient expired.An investigation was completed at the customer site and the tavi images for this patient scan were reviewed.The customer noticed when reviewing the images, the 35%, 40% and 45% cardiac phases all looked the same.The submitter of the complaint went to the customer site to get log files and found 3 additional tavi scans that the reconstructed images looked the same, there was no report of misrepresentation.Three additional complaint records (b)(4), (b)(4) and (b)(4) will address the additional scans.The tavi scan was completed on (b)(6) 2018.The philips submitter explained the customer uses the 35% phase for tavi planning and aortic valve size.The patient had aortic valve replacement on (b)(6) 2018 and during surgery, the patient expired.The customer exam card was reviewed.The exam is a step and shoot prospective axial scan with 5% phase tolerance and during scanning, the x-rays trigger only during the selected phases.For this exam, the x-rays were planned to trigger at the 40% cardiac phase with a 5% phase tolerance; hence, the x-rays will trigger from 35% to 45% cardiac phase.A usb drive was sent to philips engineering for investigation.The files were reviewed by the common image reconstruction system (cirs) team.The digital imaging and communication (dicom ) images were reviewed by the philips console team and by clinical science.The dicom images indicated the surview length was 564.40 mm and the last reconstructed image is at location 441.9 mm, so the last axial x-ray did not execute.A bug report for this scan was not available, so it cannot be determined why the scan stopped.The operator believed they had acquired enough anatomy and the last axial x-ray would not affect the outcome and selected ¿start final reconstruction.¿ because the exam did not complete as planned, the cirs did not receive correction vectors from the electrocardiogram (ecg) wave to correctly complete reconstructions of the 35%, 40%, and 45% cardiac phases.A review of the log files by the cirs team confirmed there were no correction vectors to create the planned reconstructions.The result was that all of the reconstructed images were an average of all data acquired during the x-ray on from 35% to 45% cardiac phase and this is why the images all looked the same.The user exam card for this scan was created to label the images as 35%, 40%, and 45% phases; however, the images were not a true 35%, 40%, and 45% cardiac phase.A philips physician reviewed the information and stated that if all images for the 35%, 40%, and 45% cardiac phase were reviewed, it would have been discovered the three phases appeared to be the same phase.Per the physician, it is best practice to review all images of the acquired cardiac phases for aortic valve sizing.The customer contacted their philips application specialist to review the exam.The philips applications specialist provided additional training for cardiac scans.The customer stated in the future if this were to recur, the doctor will determine to complete a dedicated cardiac step and shoot rescan or helical cardiac rescan.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• Brand Name: ICT
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.; 595 miner rd; cleveland OH 44143
• MDR Report Key: 8091215
• MDR Text Key: 127943721
• Report Number: 1525965-2018-00422
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• PMA/PMN Number: K060937
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/19/2018

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
• Device Operator: Health Professional
• Device Model Number: 728306
• Device Catalogue Number: NCTC780
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/19/2018
• Initial Date FDA Received: 11/20/2018
• Supplement Dates Manufacturer Received: 11/19/2018
• Supplement Dates FDA Received: 03/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 85 YR