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

Model Number	20000GSA
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	01/21/2026
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 the implant was attempted but aborted.The patient has a pfo (patent foramen ovale).An asd (atrial septal defect) closure device was placed 5 days prior to the procedure.During the pascal procedure, the physician elected to go posterior to the closure device and crossed at the pfo.It is believed as the pfo was crossed and gs (guide sheath) flex added, to get posterior and gain height, the superior portion of the asd was dislodged.This may have caused increased shunting across the septum causing the patient to become unstable.The patient was desaturating as the physician attempted one grasp with the pascal device at a2p2 and was unable to optimize the position and orientation.To stabilize the patient, the physician elected to bailout the device and repair the septum with an additional closure device, supporting the original device and encompassing the pfo.The patient was also placed on a balloon pump and ecmo (extracorporeal membrane oxygenation) for further stabilization.Mr (mitral regurgitation) remained severe.
Additional Manufacturer Narrative
The following sections were updated/corrected/added: b4, g3, g6, h2, h6, and h11.H6 type of investigation: labelling review.The complaint for interaction with previously implanted devices was confirmed with empirical evidence based on complaint description.Available information suggests procedural context likely contributed to the event due to physician electing to go posterior to the closure device and crossing at the pfo (patent foramen ovale).It is believed as the pfo was crossed and gs (guide sheath) flex added, to get posterior and gain height, the superior portion of the asd was dislodged.Therefore, the most likely cause of this event is due to operational context.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: 24210090
• Report Number: 2015691-2026-10635
• Device Sequence Number: 5430822
• Product Code: NKM
• UDI-Device Identifier: 00690103216967
• UDI-Public: (01)00690103216967(17)261029(11)251029
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 03/04/2026

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 Model Number: 20000GSA
• Device Lot Number: 67116237
• 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: 01/21/2026
• Supplement Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 01/29/2026
• Supplement Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/29/2025
• 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