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	07/25/2025
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 on the second device.A large p2 prolapse with strong posterior chords creating a parachuting of prolapsed tissue were noted.Implanter grasped the posterior leaflet, lots of tissue was captured on the paddle, likely including strong posterior chord within grasp.Posterior clasp drop was successful.Anterior leaflet was captured successfully.With device closure leaflets both pulled in, once posterior suture was removed, posterior leaflet slipped above the clasp which was verified by opening implant and visualizing posterior clasp bouncing.Anterior clasp was still functional.Echo interrogation revealed long posterior leaflet moving through center of device, difficult to see, yet likely chord captured in clasp.Anterior clasp was raised.Cs (clinical specialist) suggested multiple bailout maneuvers.Md (medical doctor) attempted some movements of the implant to free the posterior leaflet from clasp yet did not want to try advanced maneuvers.Instead, md decided to close implant and release.With release, the implant initially stayed attached to the posterior leaflet.A third ace was prepped and placed laterally.A solid posterior grasp was successfully obtained with the third implant.Md decided to place a plug posterior to the second device to diminish mr (mitral regurgitation).Mr was moderate at the time of the slda.The procedure was completed successfully, and the mr was reduced from severe to mild.
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.The complaint for slda single leaflet device attachment was confirmed.Available information suggests misinterpretation of proper capture and patient anatomy likely contributed to the event.Per event description, a large p2 prolapse with strong posterior chords creating a parachuting of prolapsed tissue were noted and implanter grasped the posterior leaflet, lots of tissue was captured on the paddle, likely including strong posterior chord within grasp.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: 22677564
• Report Number: 2015691-2025-06200
• Device Sequence Number: 9000002
• Product Code: NKM
• UDI-Device Identifier: 00690103216950
• UDI-Public: (01)00690103216950(17)260317
• 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): 09/05/2025

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: 03/17/2026
• 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: 07/25/2025
• Supplement Date Received by Manufacturer: 09/03/2025
• Initial Report FDA Received Date: 07/31/2025
• Supplement Report FDA Received Date: 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/17/2025
• 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: 75 YR
• Patient Sex: Female