MAUDE Adverse Event Report: EDWARDS LIFESCIENCES CERTITUDE DELIVERY SYSTEM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9620TA29

Device Problem Unintended Movement (3026)

Patient Problem Insufficient Information (4580)

Event Date 10/06/2021

Event Type  Injury  

Manufacturer Narrative

The device was discarded.Investigation ongoing.This is one of two manufacturer reports being submitted for this case.

Event Description

As reported by our affiliate in (b)(6), the patient who underwent an implant of a 29mm sapien 3 valve, in aortic position by transcarotid approach.During the procedure, the valve moved on the balloon.The valve came out of the sheath and was dislocked of the balloon too proximal, the balloon slipped ventricular.Only the distal side of the valve was opened.There was no possibility to re-inflate.The first valve embolized towards the aorta, fixed, there was big acute aortic regurgitation.Two valves were used.The second valve was implanted.Unfortunately, the patient passed away during the procedure.The cause of death was acute aortic regurgitation.As per medical opinion, the root cause of the event may have been that the valve moved on the balloon while inserting in the sheath.Per imagery review, the second valve was placed too ventricular leading to the aortic regurgitation.

Manufacturer Narrative

This is one of two manufacturer reports being submitted for this case.Please reference 2015691- 2021 -6120.The device was discarded.As the device was discarded, no visual inspection, functional testing or dimensional testing could be performed.Procedural imagery was provided and reviewed by edwards clinicians.Per the impression: the tavr was performed with a sapien 3 (s3) 29 mm via transcarotid approach using a certitude ds.After exiting the sheath, the valve was not centered on balloon, but overimposed on one shoulder.The delivery should have been replaced at this point.If higher push forces are encountered during sheath passage, please consider checking correct valve position on balloon after partially exiting the sheath, which facilitates with retrieval in case of movement.After deployment attempt the valve embolized into the ascending aorta.Aortic regurgitation (ar) was visible.Connection to mechanical circulatory support such as ecmo or by-pass pump should be considered if the patient is hemodynamically unstable in order to finalize the correct troubleshooting.A second tavr 29 mm was also not centered on balloon, deployment too ventricular resulting in significant ar.Attempt of pulling back the valve to improve position.In such a case, consider viv as the treatment option.The work orders related to the manufacturing of the devices and components that could potentially contribute to the complaint did not reveal any manufacturing non-conformance issues that would have contributed to the complaint event.A lot history review of the related work order was performed and revealed no other complaints relating to the relevant complaint codes.As no device was returned and there is no evidence to support a manufacturing/design defect potentially contributed to the complaint, a manufacturing mitigation review is not required.Per the complaint description, the alleged certitude delivery system and sheath were used off-label via transcarotid approach.There are no specific ifu/training manuals for certitude system used for this procedure.The following ifu and training manuals in this section are for a ta procedure in the aortic position and were reviewed for guidance and instruction on device preparation and usage of the certitude delivery system.The following instructions were reviewed: ifu for certitude delivery system, device prepping manual, and procedural training manual.No ifu/training deficiencies were identified.A complaint history review on confirmed device complaints (returned and no product returned) from (b)(6) 2021 for the certitude delivery system (all models and sizes) was performed with the related codes identified.Prior closed complaints with any of the codes below were reviewed for similar events and root cause identification.Of the root causes identified, the following are potentially applicable to the complaint event: procedural factors (high push force).A review of edwards lifesciences risk management documentation was performed for this case.The reported event is an anticipated risk of the transcatheter heart valve procedure, additional assessment of the failure mode is not required at this time.The complaint was confirmed based on the provided imagery.Due to the unavailability of the complaint device, engineering was unable to perform any visual inspection, functional testing, or dimensional analysis.Therefore, the presence of a manufacturing non-conformance was unable to be determined.However, based on a review of the dhr, lot history review, and complaint history review, there is no evidence to confirm that a manufacturing non-conformance contributed to the complaint.A review of ifu/training materials revealed no deficiencies.The complaint description states, ''during the procedure, the valve moved on the balloon.The valve came out of the sheath and was dislocked of the balloon too proximal, the balloon slipped ventricular.'' the imagery review report revealed the valve was overimposed on the proximal shoulder of the delivery system.There was a significant gap towards ventricular shoulder.The valve moved further proximally as the balloon was inflated.See imagery review for details.Per the training manual, ''high push force through the sheath may be experienced.Use short movements when advancing delivery system.'' procedural factors such as high insertion angle, improper crimping, improper flushing, or even off-label use in the transcarotid vasculature can contribute to resistance with the delivery system when advancing through the sheath.Additionally, access of the carotid artery is not indicated for use with the certitude delivery system, which may have resulted in the observed difficulties inserting the delivery system into the sheath in the carotid vasculature.If high push force was used to advance the delivery system through the sheath, it is possible that the valve moved proximally off the working length during insertion.With forward force applied, it is possible that the valve was rubbed against the sheath wall resulting in the valve moving off the balloon towards the proximal shoulder.Additionally, as the valve was ''too proximal'' and the balloon ''slipped ventricular'' prior to valve deployment, the delivery system should have been replaced at this point after notifying the valve movement.After deployment attempt, the valve may have continued to move off the balloon and embolize into the ascending aorta as the balloon was inflated.As such, available information suggests that procedural factors (high insertion angle/improper crimping/improper flushing, off-label use, high push force, valve not positioned in target location prior to deployment) may have contributed to the complaint events.The ifu and training manuals have been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.No corrective or preventative actions are required.

• Brand Name: CERTITUDE DELIVERY SYSTEM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 12734249
• MDR Text Key: 283252095
• Report Number: 2015691-2021-06119
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103193046
• UDI-Public: (01)00690103193046(17)230506(10)63754503
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/06/2023
• Device Model Number: 9620TA29
• Device Lot Number: 63754503
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR
• Patient Sex: Male