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

Model Number	20000ISMA
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Intraoperative Cardiac Valve Injury (4852)
Date of Event	12/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Edwards received notification of a pascal in mitral procedure where chordae damage was reported.At first grasp with the second ace device, patient had trace-mild mr (mitral regurgitation) but gradient of 6mm.Due to patients age, physician wanted to reposition and move closer to the first ace in an attempt to lower the gradient.After releasing and repositioning, pml (posterior mitral leaflet) proved very difficult to grasp.Noted was degraded tissue integrity and possible chord entanglement but difficult to pinpoint as device was always responsive.Fluoro always used to look at catheter interaction/bowing.The second device was then placed a3/p3.There continued to be worsening mr and more evidence of multiple medial commissural chordae flails.At this point patient was hemodynamically unstable/ on more epinephrine.Decision was made to get cts (cardiothoracic surgeon) consult; iabp (intra-aortic balloon pump) was placed, and the patient went to the or (operating room) for a mvr.Mr was mild before the chordae damage.After the chordae damage mr was reported as severe.
Additional Manufacturer Narrative
The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
The following sections were updated/corrected/added: b4, d4, g3, g6, h2, h4, h6, and h11.H6 type of investigation: labelling review h6 investigation conclusions: adverse event related to patient anatomy and/or condition.The complaint for chordae damaged in attempt to capture leaflet was confirmed with empirical evidence based on clinical specialist complaint description and call meeting.Available information suggests operational context likely contributed to the event due to the patient's degraded tissue integrity and possible chord entanglement.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: 23888579
• Report Number: 2015691-2025-10559
• Device Sequence Number: 9464516
• Product Code: NKM
• UDI-Device Identifier: 00690103216950
• UDI-Public: (01)00690103216950(17)260626
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 01/29/2026

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: 06/26/2026
• Device Model Number: 20000ISMA
• 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: 12/11/2025
• Supplement Date Received by Manufacturer: 01/28/2026
• Initial Report FDA Received Date: 12/24/2025
• Supplement Report FDA Received Date: 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/26/2025
• 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: 74 YR
• Patient Sex: Female