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

Model Number	20000ISM
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	Mitral Valve Insufficiency/ Regurgitation (4451)
Date of Event	12/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Event or Problem Description
Edwards received notification of a pascal in mitral procedure where an echocardiogram revealed a single leaflet detachment from the anterior leaflet, which had prolapsed into the atrium, causing the mr (mitral regurgitation) to return to severe.Implanting physician explained the detachment occurred because the tissue had been damaged by prior endocarditis.Surgeon advised that the only feasible option is to place additional clips to stabilize the leaflets as the patient is too frail to undergo open-heart surgery.Mr before index procedure was severe.Mr after index procedure was mild.Mr after slda was severe.Patient is currently in a step-down unit and remains in stable condition.
Additional Manufacturer Narrative
The following sections were updated/corrected/added: b4, b5, g3, g6, h2, h6, and h11.H6 investigation conclusions: adverse event related to patient anatomy and/or condition available information suggests patients preexisting condition likely contributed to the event.As per medical opinion, the event occurred due to the tissue been damaged by prior endocarditis, weakening the leaflet and increasing the risk of slda.An additional intervention involving two new pascal ace devices was performed, since the patient would not be able to undergo open-heart surgery.However, the level of regurgitation remained severe, leaving open-heart surgery as the only remaining option.The device history record review was completed, and this device passed 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.
Event or Problem Description
12dec2025 - additional information received: plan is to keep the patient for observation and retry with additional clip(s) on monday am ((b)(6)).Surgeon seems cautiously optimistic it will work.18dec2025 - additional information received: on (b)(6) 2025 a follow-up procedure was performed by adding two additional pascal ace clips.The severe regurgitation is grossly unchanged.The surgeon suggested option of an open chest procedure, but previously stated patient was not a good candidate.Prior to the suggestion of using a teer clip, use of another device was discussed.Patient is home and doing ok.

• 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: 23804805
• Report Number: 2015691-2025-10170
• Device Sequence Number: 7732400
• Product Code: NKM
• UDI-Device Identifier: 00690103216950
• UDI-Public: (01)00690103216950(17)260625
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2026

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: 06/25/2026
• Device Model Number: 20000ISM
• 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: 12/09/2025
• Supplement Date Received by Manufacturer: 01/19/2026
• Initial Report FDA Received Date: 12/15/2025
• Supplement Report FDA Received Date: 01/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/25/2025
• 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: Required Intervention
• Patient Sex: Male