MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD; SYSTEM, X-RAY, ANGIOGRAPHIC

Model Number ALLURA XPER FD20 BIPLANE

Device Problem Display or Visual Feedback Problem (1184)

Patient Problems Ruptured Aneurysm (4436); Insufficient Information (4580)

Event Date 08/28/2023

Event Type  Death  

Event Description

It was reported to philips that during a ruptured cerebral aneurysm procedure on (b)(6) 2023, the allura xper fd20 biplane system would not allow the use of 3dra (3d functionality/procedures), which allegedly resulted in the use of more radiation and contrast and extended the length of the procedure by one hour, while the staff tried to resolve the issue.It was reported that the patient passed away on (b)(6) 2023.Philips has started an investigation regarding the reported issue.

Manufacturer Narrative

Patient's date of birth, age and gender added.

Manufacturer Narrative

Corrected data: product information.Addtl.Manufacturer narrative: philips has investigated this complaint.According to the additional information obtained, on (b)(6) 2023, approximately halfway through an emergency coiling procedure on a ruptured cerebral aneurysm in the left anterior choroidal artery, the physician attempted to use the 3d-ra (3d rotational angiography) supporting tool, and noted the tool was unavailable.The procedure was reported to have been delayed for more than one hour whilst the physician and team elected to undertake troubleshooting with over-the-phone support from their lead ir radiographer and philips.During this time, the patient did not require any additional medical intervention other than standard of care (keeping the catheters flushed with heparinized saline).The physician stated that no obvious change in parameters was noticed during the extended procedure time to suggest deterioration in the patient condition.When the troubleshooting was unsuccessful, the physician elected to continue the procedure with the philips allura system using the diagnostic ct scans which had been previously acquired and several dsa (digital subtraction angiography) runs.The physician confirmed that the aneurysm was treated safely and coiled adequately.The physician also reported that the patient had a repeat scan a couple of days after the procedure, which did not show a rebleed or stroke.In the post procedure recovery time frame, it was reported that the patient condition was poor.The patient expired on (b)(6) 2023, at 13.30h and, per the death certificate, the cause of death was documented as subarachnoid hemorrhage from a ruptured brain aneurysm located in the left anterior choroidal artery.The physician indicated that the most likely cause of the patient¿s death was the large blood load from the patient¿s initial stroke.Based upon the information received, philips concludes that the unavailability of the 3d-ra supporting tool did not cause or contribute to the patient outcome.A log file analysis and site visit by a philips field service engineer (fse) confirmed that the 3d-ra supporting tool was not available on the philips allura system on the day of the reported event.On (b)(6) 2023, during a service activity, a philips fse did not complete the setting of the examination patient and x-ray (epx) database that is required for the use of the 3d-ra supporting tool.As a result, the 3d-ra tool was not available.A philips fse went on site on (b)(6) 2023, and completed setting the examination patient and x-ray (epx) database, which restored the 3d-ra functionality.3d-ra is a software product (interventional tool) intended to assist in the diagnosis and treatment of endovascular diseases, for example, stenosis, aneurysms, and arteriovenous malformations.3d-ra provides high-speed and high-resolution 3d visualization of vessels and bones anatomy and assists physicians in analyzing two-dimensional x-ray images by creating three-dimensional views from sets of two-dimensional images created during rotational angiographic runs.3d-ra is intended to be used in combination with a philips interventional x-ray system.Images created by the viewing application are artificially reconstructed images.Diagnosis or treatment cannot be solely based on these images.All findings, decisions, and diagnoses must be confirmed by the use of conventional (2d) x-ray imaging.The codes were updated based on investigation outcome.

• Brand Name: ALLURA XPER FD
• Type of Device: SYSTEM, X-RAY, ANGIOGRAPHIC
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer Contact: dusty leppert ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 17713398
• MDR Text Key: 322994391
• Report Number: 3003768277-2023-04907
• Device Sequence Number: 1
• Product Code: IZI
• UDI-Device Identifier: 00884838059061
• UDI-Public: 00884838059061
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K121772
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ALLURA XPER FD20 BIPLANE
• Device Catalogue Number: 722013
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 73 YR
• Patient Sex: Female