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	01/07/2026
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 procedure where air was introduced into the patient.Noted was a drop in pressures with the insertion of the guide.St elevation after flush with implant system insertion.Ic (implanting cardiologist) mentioned an air bubble likely got into the coronaries hence the reason he cathed the arteries to ensure they were not blocked.The patient had a vasovagal event with insertion of guide sheath which, as the ic explained, the bubbles tend to get pulled into the coronaries with the drop in pressures.O2 was administered.A coronary angiogram revealed no blockage, yet significant cad demonstrated.St elevation resolved before resuming procedure and there was no st elevation during the procedure.Comments were made of possibly lower lvef post-procedure, yet nothing significant.The procedure was completed.Mr (mitral regurgitation) reduction to mild was achieved.The patient is stable.
Additional Manufacturer Narrative
H6 type of investigation: labelling review.The complaint for inadequate aspiration, air remaining in device during insertion was unable to be confirmed as no air was observed entering the coronaries during procedure, and the root cause is indeterminable.The clinical specialist noted that air was a suspected cause of the st elevation, but no air was observed entering the coronaries during the procedure.Follow-up discussions did not reveal any use errors or potential device defects.Neither imaging nor product was returned for evaluation.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.The device history record review was completed, and this device passed all manufacturing and sterilization inspections.No nonconformances related to the complaint event was 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: 24098875
• Report Number: 2015691-2026-10469
• Device Sequence Number: 16034278
• Product Code: NKM
• UDI-Device Identifier: 00690103216967
• UDI-Public: (01)00690103216967(17)260508
• 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: 2026
• 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): 03/03/2026

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: 05/08/2026
• Device Model Number: 20000GSA
• Device Lot Number: 66601268
• 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: 01/07/2026
• Supplement Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 01/16/2026
• Supplement Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/08/2025
• 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: 76 YR
• Patient Sex: Male