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

Model Number	20000ISA
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cusp Tear (2656)
Date of Event	11/18/2025
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 implant was attempted and aborted due to chordae damage when attempting to capture the leaflet.Noted were anatomical and procedural challenges due to medial commissure location, posterior calcium ridge being present, and dense chordal regions.Mr (mitral regurgitation) was severe at the beginning of the procedure and severe after the chordae damage.High gradient (10 mmhg) was noted.Mr severity was not reduced.The device was bailed out.The patient was sent to atrial surgical repair in the afternoon where the mv was replaced with bio prosthetic 27mm mitral valve.Surgery confirmed chordae was intact, but there were 2 perforations on the pml just above a prominent ca++ ridge (p3 segment).The patient is recovering well.No imaging is available for review.
Additional Manufacturer Narrative
The following sections were updated/corrected/added: b4, d4, g3, g6, h2, h4, h6, and h11.H6 investigation conclusions: adverse event related to patient anatomy and/or condition.The complaint for leaflet damaged while capturing was confirmed with empirical evidence based on the report by the edwards clinical specialist.Available information suggests anatomical and procedural challenges likely contributed to the event due to medial commissure location, posterior calcium ridge being present, and dense chordal regions.The combination of anatomical challenges may have resulted in difficulties with navigation, tension on the implant and/or multiple capture attempts leading to the leaflet damage.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.

• 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: 23638630
• Report Number: 2015691-2025-09535
• Device Sequence Number: 9805548
• Product Code: NKM
• UDI-Device Identifier: 00690103216943
• UDI-Public: (01)00690103216943(17)260828
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: P220003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 01/13/2026

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: 08/28/2026
• Device Model Number: 20000ISA
• 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: 11/18/2025
• Supplement Date Received by Manufacturer: 01/12/2026
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 01/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/28/2025
• 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 Age: 71 YR
• Patient Sex: Female