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	07/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Edwards received notification of a pascal in mitral procedure where a slda (single leaflet device attachment) occurred.Two additional ace devices were placed.A third ace was attempted medial to the middle device.The posterior leaflet kept slipping out of the device.The device was elongated and came back to la to reset.It was noted the posterior leaflet slipped out of the a2p2 ace.The physician was unable to place the device right next to this one due to lack of posterior leaflet.The perceived root cause is lack of leaflet integrity, heart being extremely hyper dynamic during procedure, and patient on pressors and iabp.The third device was placed at a3p3 and the annulus was stable.The procedure was completed successfully, and the mr was reduced from severe to moderate/severe.Grade of mr at time of slda was moderate-severe to severe.
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: b4, d4, g3, g6, h2, h4, h6, and h11.H6 investigation conclusions: adverse event related to patient anatomy and or condition.The complaint for implant dislodged from a single leaflet, single leaflet device attachment (slda) intra-procedure was confirmed.Available information suggests patient anatomy likely contributed to the event.Per event description, the patients posterior leaflet was very friable.Additionally, the perceived root cause is lack of leaflet integrity and heart being extremely hyper dynamic during procedure and patient on pressors and iabp.The device history record review was completed, and this device passed all manufacturing and sterilization inspections.There were no nonconformances related to the complaint event.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: 22555238
• Report Number: 2015691-2025-05898
• Device Sequence Number: 18553514
• Product Code: NKM
• UDI-Device Identifier: 00690103216950
• UDI-Public: (01)00690103216950(17)251009
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 08/14/2025

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: 10/09/2025
• 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: 07/10/2025
• Supplement Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 07/21/2025
• Supplement Report FDA Received Date: 08/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/09/2024
• 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: Other
• Patient Sex: Male