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)
Type of Reportable Event	Serious Injury
Event or Problem Description
Edwards received notification of a pascal in mitral position where the patient had a late slda (single leaflet device attachment).Physician stated that slda occurred due to extensive leaflet mobility due to barlow's anatomy.The physician questioned whether one row of retention elements is enough for patients with this anatomical defect.The starting mr was severe/torrential and ending mr was mild, but the mr after the slda happened was back to severe.The patient had a heart failure hospitalization as a result of the slda event but is now discharged and stable.Currently there are discussions on reintervention for the patient, but the patient is very frail.Currently managed on meds, may consider additional teer reintervention in the future.
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 investigation conclusion code: adverse event related to patient anatomy and/or condition 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), who was present on site.Available information suggests patient pre-existing conditions likely contributed to the event due to the patient having extensive leaflet mobility due to barlow's anatomy.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: 21986433
• Report Number: 2015691-2025-03651
• Device Sequence Number: 4478451
• Product Code: NKM
• UDI-Device Identifier: 00690103216950
• UDI-Public: (01)00690103216950(17)250806
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 06/11/2025

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: 08/06/2025
• 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: 04/15/2025
• Supplement Date Received by Manufacturer: 05/20/2025
• Initial Report FDA Received Date: 05/08/2025
• Supplement Report FDA Received Date: 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/06/2024
• 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: Hospitalization
• Patient Sex: Female