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

Model Number 9750TFX23A

Device Problem Incomplete Coaptation (2507)

Patient Problem Aortic Regurgitation (1716)

Event Date 10/27/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The investigation is in progress, a supplemental report will be submitted.

Event Description

Edwards received notification form a field clinical specialist that after deployment of the 20mm s3 valve there was significant central ai without a known cause.The wire was removed, a pigtail catheter was guided across to free a ¿frozen¿ leaflet if that was the issue.Neither of these options resolved any issues.There was no visual evidence of leaflet overhang or structural anatomy from the patient causing the issue.Post-dilatation was performed and the ai only got worse.The decision was made to place a 23mm inside of the 20mm valve.The 23mm valve deployment was successful and the patient left the room in stable condition with no ai.

Manufacturer Narrative

The device was not returned for evaluation, therefore a no product return engineering evaluation was performed.During the manufacturing process, the device was visually inspected and tested several times.All the inspections are conducted on 100% of units, except in the case of product verification (pv) testing, where the tested units are chosen on a sampling basis.All tested sample units for this lot passed pv testing.These inspections and tests during the manufacturing process support that it is unlikely that a non-conformance contributed to the reported complaint.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 for central regurgitation was unable to be confirmed due to the unavailability of the device/imagery for evaluation.A review of the dhr and lot history, revealed no indication that a manufacturing non-conformance contributed to the complaint.Additionally, a review of manufacturing mitigations supports that proper inspections are in place during the manufacturing process to detect issues relating to the complaint.Review of ifu/training manuals revealed no deficiencies.During the manufacturing process, all sapien 3 ultra valves are 100% visually inspected for defects and 100% tested for coaptation prior to release for distribution.This makes it highly unlikely that a manufacturing defect or device malfunction would contribute to the event.Per the instructions for use (ifu), central regurgitation is a potential adverse event associated with bioprosthetic heart valves and the transcatheter aortic valve replacement (tavr) procedure.There are multiple patient and procedural factors that alone or in combination can cause or contribute to central regurgitation including malposition of the valve, impingement of a leaflet due to the guide wire, over inflation of the deployment balloon, post dilation of the implanted valve, and slow recovery of adequate ventricular flow post valve deployment and rapid pacing. all of these factors have the potential to contribute to suboptimal coaptation of the valve leaflets and cause central aortic insufficiency.As reported, the valve was deployed with an extra volume (+1cc) and ¿post-dilatation was performed in case there was a piece of the patient anatomy protruding into the cage or on top of the leaflet.The ai only got worse.¿ per training manual, ¿the delivery system requires a prescribed volume for thv deployment and proper function¿ and ¿if regurgitation is central rather than paravalvular, do not post-dilate.¿ overexpansion may have initially led to the improper coaptation of valve leaflet, resulting in central leakage.The post dilation may have further damaged the leaflet, worsening the central leakage.As such, available information suggests that procedural factors (over inflation of balloon and post dilation) may have contributed to the complaint event.However, a definitive root cause was unable to be determined at this time.No labeling/ifu deficiencies were identified; therefore, no corrective or preventative action, nor product risk assessment is required at this time. 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.

• Brand Name: EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 10880197
• MDR Text Key: 217714606
• Report Number: 2015691-2020-14576
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• PMA/PMN Number: P140031
• 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: 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/23/2022
• Device Model Number: 9750TFX23A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/27/2020
• Initial Date FDA Received: 11/20/2020
• Supplement Dates Manufacturer Received: 12/22/2020
• Supplement Dates FDA Received: 12/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention