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	04/02/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer's investigation is ongoing.A follow-up report will be submitted when manufacturer's investigation is complete.
Event or Problem Description
Edwards received notification of a pascal in mitral procedure where an intra-procedure slda (single leaflet device attachment) occurred at the central/lateral ace implant following avp (amplatzer vascular plug) attempt, which failed to reduce the mr (mitral regurgitation).Ace implant was suggested prior.However, the physician chose avp orifice measurement.A third ace implant was placed centrally between the first and second implants.A fourth ace implant was placed laterally to stabilize the slda.Pre-procedure mr was severe.Mr at the time of slda was moderate.The procedure was completed and mr was reduced from severe to moderate.
Additional Manufacturer Narrative
The following sections were updated/corrected/added: b4, d4, g3, g6, h2, h4, h6, and h11.The reported event implant dislodged from a single leaflet, single leaflet device attachment (slda) intra-procedure was confirmed based on the information provided.Available information suggests procedural factors likely contributed to the event.Based on the information provided by the on-site edwards clinical specialist, the physician opted to attempt avp placement after creation of a triple orifice with the initial ace implants, and the slda occurred following the plug attempt, requiring additional ace implants to achieve stabilization.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: 24831162
• Report Number: 2015691-2026-14020
• Device Sequence Number: 10306237
• Product Code: NKM
• UDI-Device Identifier: 00690103216950
• UDI-Public: (01)00690103216950(17)261002
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P220003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 05/29/2026

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: 10/02/2026
• 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: 04/02/2026
• Supplement Date Received by Manufacturer: 05/29/2026
• Initial Report FDA Received Date: 04/09/2026
• Supplement Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/02/2025
• 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: 2 MO
• Patient Sex: Unknown