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

Model Number	20000ISMA
Medical Device Problem Codes	Activation Failure (3270); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Mitral Valve Insufficiency/ Regurgitation (4451)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Event or Problem Description
Edwards received notification of a pascal in mitral position where the physician informed the clinical specialist that there was an slda (single leaflet device attachment) that occurred.Baseline mr (mitral regurgitation) prior to index procedure was severe and post procedure was mild, but after the slda happened is unknown.The patient is stable and the plan is to stabilize the valve with another implant.
Additional Manufacturer Narrative
The following sections were updated/corrected/added: b4, d6b, g3, g6, and h11.Supplemental report to add explant date.
Additional Manufacturer Narrative
Additional type of investigation code: labelling review.The complaint for reduced therapeutic efficacy over time / other was confirmed with empirical evidence as reported by the edwards clinical specialist.No manufacturing non-conformities were identified and there is no evidence to support a failure was the results of design or manufacturing.The device history record review was completed, and this device passed all manufacturing and sterilization inspections.No nonconformance's related to the complaint event were identified.Since no edwards defect was identified, corrective or preventative actions are not required.Available information suggests that patient conditions due to poor leaflet integrity may have contributed to the reported event.However, a definite root cause is unable to be determined.The device training manuals instructs the operator to consider all procedural and anatomical factors.Physicians are extensively trained by edwards before they are qualified to use the device system.Training includes patient screening, device preparation, approach, deployment, imaging, procedure-specific training manuals and proctored procedures.As described in the event description, post-procedure leaflet tear was likely due to poor leaflet integrity, however, a definite root cause is unable to be determined because initial leaflet condition is unknown.The patient is stable with a plan for surgical reintervention.The procedure was completed successfully, and the mr was reduced from severe to mild.
Event or Problem Description
Additional information received stated that there was a post-procedure leaflet tear, due to poor leaflet integrity.It was determined this was not a device issue but rather a tissue issue.Baseline mr (mitral regurgitation) prior to index procedure was severe and post-procedure was mild, but after the leaflet tear occurred was severe.The outcome of the patient is stable with a plan for surgical reintervention.The procedure was completed successfully, and the mr was reduced from severe to mild.

• 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: 22079867
• Report Number: 2015691-2025-04090
• Device Sequence Number: 8702246
• Product Code: NKM
• UDI-Device Identifier: 00690103216950
• UDI-Public: (01)00690103216950(17)251003
• 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
• Device Explanted 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,Followup
• Report Date (Section B): 07/11/2025

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: 10/03/2025
• 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: 05/01/2025
• Supplement Date Received by Manufacturer: 06/18/2025; 07/01/2025
• Initial Report FDA Received Date: 05/23/2025
• Supplement Report FDA Received Date: 07/02/2025; 07/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/03/2024
• 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: Required Intervention
• Patient Sex: Male