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

Model Number 9750TFX23

Device Problems Calcified (1077); Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/07/2024

Event Type  Injury  

Event Description

Per report received from romania, it was a case of an implant of a 23mm sapien ultra valve in aortic position by transfemoral approach.After the valve deployment, the valve appeared to not be fully expanded due to the narrow lvot and quite significant calcification.It was decided to post-dilate the valve with the same ds that was in the descending aorta.During the post-dilation, the pacing was intermittent (2:1) and not stable.It was decided to introduce a new pacing lead from the left femoral vein and the post-dilation was performed with the patient stable and the valve appeared to be fully expanded.After this post-dilation, it was observed by tee and angio that the valve presented a severe central leak in the right coronary cusp.The patient was still stable.The wire was removed, but the severe central leak from the rcc persisted.Several maneuvers with the pigtail were unsuccessfully performed to activate the leaflet since it was not moving or was visible on tee.It was decided to perform a viv using a new 23mm s3u, and the valve was successfully implanted.The patient did not suffer any injury and was noted as to be stable throughout the whole procedure.Per physician, the root cause was unknown but could have possibly been due to the prolonged manipulation with the wires and delivery system due to dysfunctional pacing.

Manufacturer Narrative

Investigation is ongoing.H3 other text : remains implanted.

Manufacturer Narrative

A supplemental mdr is being submitted due to engineering evaluation findings.The device was not returned to edwards lifesciences for evaluation.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 this event is not required at this time.The complaint for "deployed valve exhibits central regurgitation" was confirmed based on evaluation of provided imagery, however the complaint for "leaflet motion restricted-in patient" was unable to be confirmed.Available information suggests that patient factors (calcification) and procedural factors (under expanded valve) likely contributed to the event as it was reported that "the valve appeared to not be fully expanded due to the narrow lvot and quite significant calcification." although the thv depends on native landing zone calcification for anchoring, bulky calcification within the landing zone may impact the ability for the thv leaflets to properly function.The bulky calcium can impinge on the thv leaflets, preventing them from proper coaptation and lead to regurgitation.Deploying the valve using less than the prescribed volume may result in inability for the valve leaflets to properly function.The decrease in valve diameter due to lack of deployment volume may result in a gap between the valve leaflets preventing the valve from fully closing.Under expanding the valve may also prevent the valve leaflets from fully opening and allowing proper ejection fraction.Lastly, shape of existing landing zone (valve/ring, non-circular annulus, bicuspid patient, etc.) may result in under deployment of the valve.The valve must be fully deployed for proper function.A technical summary applies to this complaint event and establishes, through extensive complaint investigations, that central regurgitation events post-deployment with or without report related to leaflet mobility for the s3 and s3u valves have not been associated with device malfunctions or manufacturing nonconformances.Rather, the root cause for these events have historically been due to procedural factors (malposition, slow recovery of blood flow, leaflet impingment due to calcification or guidewire, over-inflation, post-dilation, and/or under-expansion).Review of the ifu and training materials is detailed in the technical summary and continues to provide adequate instructions on device use, risks, and precautions.In addition, review of manufacturing mitigations is captured in the technical summary, which are still in place.With no unique issues or concerns raised with this complaint, this event will be included in ongoing monitoring and trending with no pra or capa required at this time.

• Brand Name: EDWARDS SAPIEN 3 ULTRA
• 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: 18824013
• MDR Text Key: 336735385
• Report Number: 2015691-2024-01550
• Device Sequence Number: 1
• Product Code: NPT
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9750TFX23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2023
• 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: 74 YR