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

Model Number	20000GSA
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	04/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.Additional h6 health effect- impact code: non-serious injury/illness/impairment.
Event or Problem Description
Edwards received notification of a pascal in mitral position where an implant was attempted but aborted because the physician decided to remove the implant when echocardiographic evidence of air bubbles were present.The patient was stable throughout the procedure in spite of the operator's concerns about the echocardiographic evidence of air bubbles in the left atrium while steering the implant to the mitral valve.The physician decided to bailout the implant before leaflet capture was attempted.The procedure was completed successfully with a reduction in mr from severe to mild.Per internal imaging review of intraprocedural tee imaging, there appears to be small mobile air bubbles emerging from the gs (guide sheath) tip when first visualized across the intra-atrial septum.In subsequent imaging, air is no longer observed.At the time of implant release of both of the pascal devices, air introduction occurred.Small mobile air bubbles were also observed during release of the implants.The bubbles were observed in the left atrium, left ventricle and the aorta.The source of bubbles appears to be at the junction of the proximal portion of the implant and the distal portion of the implant catheter.In subsequent imaging, air is no longer observed.There were no recorded ekg changes during any of the time points, or changes in heart rate/rhythm.
Additional Manufacturer Narrative
The following sections were updated/corrected/added: b4, d4, g3, g6, h2, h4, h6 and h11 additional h6 type of investigation codes: analysis of images and labelling review the complaint for device not completely de-aired during flushing and preparation was confirmed with objective evidence based on evaluation of returned imaging.Evaluation of returned imaging confirmed the presence of air during use of the gs and is during the procedure, however, no device issues related to the event could be identified.A dhr review of the lot in question revealed no non-nonconformances related to the event.Evaluation of the returned implant system revealed no defects, damage, or leaks.Since no edwards defect was identified, corrective or preventative actions are not required.Potential root causes for the presence of air may include: - omission of a flushing/de-airing step - improper stopcock/syringe technique - air from an alternative non-pascal device, fluid line, or procedural step however, a true root case is unable to be determined.

• 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: 22074080
• Report Number: 2015691-2025-04059
• Device Sequence Number: 9363426
• Product Code: NKM
• UDI-Device Identifier: 00690103216967
• UDI-Public: (01)00690103216967(07)251031
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P220003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 07/28/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2025
• Device Model Number: 20000GSA
• Device Lot Number: 66063492
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2025
• 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: 04/28/2025
• Supplement Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 05/22/2025
• Supplement Report FDA Received Date: 07/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2024
• 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
• Patient Sex: Male