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

Model Number	20000ISMA
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	Mitral Valve Insufficiency/ Regurgitation (4451)
Date of Event	03/25/2025
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 position where there was an slda (single leaflet device attachment).The team had expressed concerns with the posterior grasp, but the physician was confident with the grasp.The team optimized multiple times.The device was stable post release, but 15 minutes later (after the guide was already removed), the posterior leaflet came out.The team went back in and stabilized the device with another ace.The procedure was completed successfully with a reduction in mr (mitral regurgitation) from severe to none/trace.When the slda happened, the mr was severe.The patient is in stable condition.
Additional Manufacturer Narrative
The following sections were updated/corrected/added: b4, d4, g3, g6, h2, h4, h6 and h11.The complaint for 'implant dislodged from a single leaflet, single leaflet device attachment (slda) post-procedure' was confirmed with empirical evidence based on information provided by edwards clinical specialist (cs).Available information suggests insufficient posterior leaflet grasp likely contributed to the event as insufficient leaflet capture may not allow the implant's retention elements enough leaflet to grasp, causing the leaflet to slip out of the implant clasp.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.Based on extensive complaint investigations, the root cause for slda events are most likely due to patient factors, procedural factors, imaging factors, or a combination of these factors and are not attributed to device malfunctions or manufacturing nonconformances.The pascal and pascal precision ifu and training materials provide adequate instructions on device implant, leaflet capture, and optimization prior to release.These events will continue to be monitored, and complaints trending and control limits are managed and assessed.

• 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: 21849632
• Report Number: 2015691-2025-02932
• Device Sequence Number: 15628155
• Product Code: NKM
• UDI-Device Identifier: 00690103216950
• UDI-Public: (01)00690103216950(17)251017(11)241017
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 05/23/2025

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: 10/17/2025
• 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: 03/25/2025
• Supplement Date Received by Manufacturer: 05/09/2025
• Initial Report FDA Received Date: 04/16/2025
• Supplement Report FDA Received Date: 05/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/17/2024
• 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: Required Intervention
• Patient Sex: Male