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

Model Number	20000ISMCL
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	Tricuspid Valve Insufficiency/ Regurgitation (4453)
Date of Event	12/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Edwards received notification of a pascal in tricuspid procedure where the post procedural tte notes noted the device appears detached from the posterior leaflet but still attached to the septal leaflet.Screening tte noted potential anatomical exclusions were identified.Tr (tricuspid regurgitation) at index procedure was torrential.Tr after index procedure was moderate.Tr regurgitation after slda (single leaflet device attachment) was moderate.(b)(4) - additional information received.Follow-up information was received from core lab.Core lab reviewed the discharge tte, echo date of (b)(6) 2025, and confirmed the slda.Tr grade was massive at discharge.
Additional Manufacturer Narrative
The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.B2: other serious - even though there was no reintervention the final mitral regurgitation reduction was impacted by the event.
Additional Manufacturer Narrative
The following sections were updated/corrected/added: a4, b4, d4, g3, g6, h2, h4, h6, and h11.The complaint for slda (single leaflet device attachment) post procedure was confirmed.Available information does not suggest what factors contributed to the event.After review of procedural tte by safety, there are no comments regarding the patients anatomy.Due to the limited details, the definitive root cause is indeterminable.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: 24203367
• Report Number: 2015691-2026-10614
• Device Sequence Number: 13213942
• Product Code: NKM
• UDI-Device Identifier: 00690103216950
• UDI-Public: (01)00690103216950(17)260520
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 02/03/2026

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: 05/20/2026
• Device Model Number: 20000ISMCL
• 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: 01/23/2026
• Supplement Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 01/28/2026
• Supplement Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/20/2025
• 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: Other
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 82 KG