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

Model Number	20000ISM
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Mitral Valve Insufficiency/ Regurgitation (4451)
Date of Event	10/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Per report received from japan, edwards received notification of a pascal precision ace procedure in mitral position.Regarding the case on (b)(6) 2025 in which an ace device was centrally implanted at the a2-p2 segment, mitral regurgitation (mr) recurred.During the initial procedure, a small lesion remained on the grasped lateral side, but mr had resolved and hemodynamics had improved, so the procedure was concluded.However, mr later recurred from that same location (grade 4+).There was just enough space to place another ace, and since leaflet approximation was favorable, pascal was selected instead of mitraclip.Although the transseptal puncture (tsp) was low, the procedure proceeded with reference to the previous case.The first device was successfully implanted in close proximity to the prior one.A trace amount of mr remained between the devices, but it was trivial (grade 0+), and the procedure was completed.27oct2025 - additional information received from ew clinical specialist.The causal relationship between the reintervention and the device.While anatomical factors of the patient were also involved, the details remain unclear.
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 type of investigation: labelling review.The complaint for reduced therapeutic efficacy over time/incorrect implant position was confirmed.Available information states that a small lesion remained on the lateral side during the initial procedure and there was enough space to place another implant to address the recurring mr.According to the clinical specialist, anatomical factors impacted the need for procedure but could not be confirmed.Given the information provided, a definite root cause is unable to be determined as imaging and information regarding additional intervention was unavailable.The device history record review was completed.While this device did not pass 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: 23452962
• Report Number: 2015691-2025-09015
• Device Sequence Number: 8961171
• Product Code: NKM
• UDI-Device Identifier: 00690103216950
• UDI-Public: (01)00690103216950(17)260415
• Combination Product (Y/N): N
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2025

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: 04/15/2026
• 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: 10/21/2025
• Supplement Date Received by Manufacturer: 12/05/2025
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/15/2025
• 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: 85 YR
• Patient Sex: Female