MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9600TFX23J

Device Problems Fluid/Blood Leak (1250); Incomplete Coaptation (2507)

Patient Problem Insufficient Information (4580)

Event Date 02/27/2022

Event Type  Injury  

Manufacturer Narrative

Investigation is ongoing.

Event Description

As reported by the edwards (b)(4) affiliate, during a transfemoral tavr procedure with a 23mm sapien 3 valve, central regurgitation due to restriction of leaflet motion occurred.After the bav, the valve was deployed with nominal volume.To resolve some pvl, post-dilation was executed.After the devices were removed from the ventricle, central regurgitation through the valve was observed.Angiography confirmed severe regurgitation.Echo revealed a prolapsed rcc leaflet.The physician poked at the leaflet by catheter; however, the leaflet remained stuck.A second valve was implanted by valve in valve technique.The procedure was closed without further complications.The procedure was emergent and executed under intra-aorta balloon pumping (iabp).

Manufacturer Narrative

Added h.6 type of investigation and investigation findings.Corrected h.6 investigation conclusions.No device was returned for evaluation.A device history review (dhr) was performed and did not reveal any manufacturing nonconformance issues that would have contributed to the complaint event.As the events were unable to be confirmed, a lot history review was not required to be performed.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.The ifu, device preparation manual, and procedure training manual were reviewed.During thv delivery, thv delivery, to prevent possible leaflet damage, the thv should not remain in the expandable sheath for over 5 minutes.Verify the correct position of the thv with respect to the target position.As necessary, utilize the flex wheel to adjust the co axiality of the thv and the fine adjustment wheel to adjust the position of the thv.Before deployment, ensure that the thv is correctly positioned between the valve alignment markers and the flex catheter tip is over the triple marker.Begin thv deployment by unlocking the inflation device.Begin rapid pacing; once systolic blood pressure has decreased to 50 mmhg or below, balloon inflation can commence.Deploy the thv by inflating the balloon with the entire volume in the inflation device, hold for 3 seconds and confirm that the barrel of the inflation device is empty to ensure complete inflation of the balloon.Deflate the balloon.Turn off the pacemaker when the delivery system balloon has been completely deflated.Post-deployment assess the thv post-deployment using fluoroscopy.Withdraw the delivery system from the thv before assessing.Perform an aortogram with wire still in the lv to assess thv position and complete expansion.Rao projection provides the best view of the lv (no overlap with aorta).Typically, final deployed thv position will be around 70/30 to 80/20 (aortic/ventricular) when using optimal initial thv positioning where the center marker is within the optimal initial center marker zone.Anatomy (stj, calcification, coronaries, etc.), % area sizing, thv size and foreshortening/inflation volume should also be considered when initially positioning the thv.Waiting some time may help in assessing final pvl.Assess the thv post-deployment using tee in multiple planes.Assess the thv post-deployment using echo in multiple planes.No ifu/training deficiencies were identified.Complaint histories for all reported events are reviewed against trending control limits monthly, and any excursions above the control limits are assessed and documented as part of this monthly review.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.Since no product non-conformances were identified, a product risk assessment (pra) escalation is not required.Since no edwards defects were identified, no corrective or preventative actions are required.The motion restricted leaflet and subsequent central regurgitation were unable to be confirmed due to unavailability of provided imagery and returned product.A review of dhr did not identify any manufacturing non-conformities that would have contributed to the reported event.A review of ifu/training materials revealed no deficiencies.During the manufacturing process, all sapien 3 valves are 100% visually inspected for defects and 100% tested for proper coaptation under physiological backpressure conditions prior to release for distribution.Therefore, it is highly unlikely that a manufacturing defect or device malfunction contributed to the event.As reported, ''during the transfemoral tavr procedure for 23mm sapien 3 valve, central regurgitation due to restriction of leaflet motion occurred.After the bav, the valve was deployed with nominal volume.To resolve the pvl, post-dilation was executed.Although all the device used for procedure was removed from the ventricle, central regurgitation was observed.Angiography revealed severe regurgitation.Echo revealed prolapsed rcc leaflet.The physician poked at the leaflet by catheter; however, leaflet was stuck''.Per training manual, the post-dilation has benefit to reduce the paravalvular ar; however, it is a risk factor for central ar due to over expand or inflate the deployed valve.Over expanded or inflated valve can over stretch the leaflet, and prevent the leaflets from proper coaptation resulting in central regurgitation.Since the leaflet motion restricted and central regurgitation were observed after the post-dilation, available information suggests the procedural factors (post-dilation) may have contributed to the complaint event.

• Brand Name: EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE
• 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: 13865953
• MDR Text Key: 290171283
• Report Number: 2015691-2022-04557
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103195033
• UDI-Public: (01)00690103195033(17)231215
• 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,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/15/2023
• Device Model Number: 9600TFX23J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 88 YR
• Patient Sex: Female