MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS PASCAL PRECISION; MITRAL VALVE REPAIR DEVICES

Model Number	20000IS
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	03/26/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Edwards received notification of a pascal precision ace in mitral position where the patient had a suspected stroke on post-operative day (pod) 1.From steering down to the first leaflet capture went very smoothly.However, there was a residual jet from the lateral side of the implant.Grasping was done a total of 5 times to adjust the capture position.No damage was found to the leaflets in an injury check.A sixth grasp was done with the final idea of changing the trajectory from lateral to medial, but the result was unchanged.A decision was made to bailout the p5 device and change to a p10 device.The residual mr did not seem to have changed much, but there was a clear improvement in hemodynamics.There was concern about hemolysis due to the bulky calcification on the leaflet and the implant, but this seemed a limit of m-teer, so the implant was released.The residual mr was mild to moderate.The heart team was very satisfied with the pascal procedure.However, a suspected stroke was observed on pod 1.Additional information was received stating it was ischemic cerebral infarction.Act level was 275 just before gs (guide sheath) insertion, and heparin was added after that.The patient originally had paroxysmal atrial fibrillation and had a history of ablation.There were no device issues during or post-implantation.The customer was not sure if there was recurrence of atrial fibrillation (af) but assumed that the af might have recurred due to stimulation after m-teer.A small thrombus might have formed and led to cerebral infarction.Mri was performed the day after surgery in the morning and found that the blood clot was in the brain stem and it was treated with medication.The details of medications were unknown since the patient was also treated by neurology department.The patient is still hospitalized and undergoing rehabilitation.Hemodynamics is stable, but paralysis is severe.The patient will be transferred to a rehabilitation facility.
Additional Manufacturer Narrative
This is a combined initial + final report which includes the investigation results below.H6 investigation conclusion code: adverse event related to patient anatomy and/or condition.The complaint for 'thrombus formation (device)' was confirmed with other empirical evidence based on information provided by the clinical specialist present at the procedure.Available information suggests patient factors (heart failure with preserved ejection fraction with coronary artery disease, severe degeneration of the leaflets, and bulky calcification) likely contributed to the event.The device history record review was completed.While this device did not pass all manufacturing and sterilization inspections, no nonconformances related to the complaint event were identified.Since no edwards defect was identified, corrective or preventative actions are not required.

• Brand Name: EDWARDS PASCAL PRECISION
• Common Device Name: MITRAL VALVE REPAIR DEVICES
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: cassandra cook ; 1 edwards way; irvine, CA 92614 ; 5743778277
• MDR Report Key: 22012451
• Report Number: 2015691-2025-03781
• Device Sequence Number: 20806556
• Product Code: NKM
• UDI-Device Identifier: 00690103216943
• UDI-Public: (01)00690103216943(17)251121
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P220003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/13/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/21/2025
• Device Model Number: 20000IS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2025
• Initial Report FDA Received Date: 05/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/21/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 85 YR
• Patient Sex: Female
• Patient Weight: 50 KG