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

Model Number	20000ISA
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 was brought back to the hospital for a repeat tte and the second lateral ace with an slda (single leaflet device attachment).The index procedure with pascal was completed successfully with an mr (mitral regurgitation) reduction from severe to moderate.Mr after the slda happened was back to severe.The hospital is proceeding with using mitraclip to re-intervene.Additional information received from the cs stated that anatomically, the leaflets were thickened and had bad tissue integrity.The patient previously had multiple bouts of infective endocarditis.The physicians believe that the cause of this was due to patient anatomy and was not device related.They believe that the tissue either tore or stretched due to the previous endocarditis infections.Post re-intervention with the mitraclip, the regurgitation was trace with a gradient of 4.The patient currently is stable post mitraclip re-intervention but has an ejection fraction of 10%.
Additional Manufacturer Narrative
The event is captured by edwards lifesciences under complaint #: (b)(4).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 implant dislodged from a single leaflet, single leaflet device attachment (slda) post procedure was confirmed empirically based on accounts by the edwards clinical specialist.Available information suggests that patient anatomy likely contributed to the event due to thickened leaflet, issues with tissue integrity, and previous complications with infective endocarditis potentially making leaflet capture difficult.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.Based on extensive complaint investigations, the root cause for slda events are most likely due to patient factors, procedural factors, imaging factors, or a combination of these factors and are not attributed to device malfunctions or manufacturing nonconformances.The pascal and pascal precision ifu and training materials provide adequate instructions on device implant, leaflet capture, and optimization prior to release.These events will continue to be monitored, and complaints trending and control limits are managed and assessed.

• 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: 20462059
• Report Number: 2015691-2024-07869
• Device Sequence Number: 8855825
• Product Code: NKM
• UDI-Device Identifier: 00690103216943
• UDI-Public: (01)00690103216943(17)250103
• 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: 2024
• 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): 10/18/2024

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: 01/03/2025
• Device Model Number: 20000ISA
• 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: 09/25/2024
• Supplement Date Received by Manufacturer: 10/17/2024
• Initial Report FDA Received Date: 10/16/2024
• Supplement Report FDA Received Date: 10/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/04/2024
• 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