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

Model Number	20000GSA
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	10/20/2025
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 there were challenging imaging windows due to anatomical shadowing and small fossa ovalis.A small pe (pericardial effusion) was noted during placement of first ace implant.The pe continued to get progressively bigger.Proceeded with second ace implant and achieved optimal mr (mitral regurgitation) reduction.The pe continued to get worse, and the patient became hypotensive which required pericardiocentesis.Patient was stabilized.
Additional Manufacturer Narrative
The following sections were updated/corrected/added: b4, g3, g6, h2, h6, and h11.H6 type of investigation - labelling review.During this mitral procedure a small pericardial effusion was noted during the placement of the first pascal ace implant.The procedure was continued, and a second ace was implanted.Through the procedure the effusion continued to progressively grow.Intervention was ultimately required to stabilize the patient.Imaging assessment could not be performed as procedural images were not available for review.Per the information provided by the edwards clinical specialist, imaging was challenging as there was anatomical shadowing.Additionally, there was a small fossa ovalis complicating the transseptal puncture.Both of these factors could have contributed to puncturing of the atrial wall during the transeptal puncture though this cannot be confirmed as the effusion was not visualized at the time of the puncture.Alternatively, it is possible the cardiac damage could have occurred from unwanted contact of the pascal implant with the cardiac anatomy.Again, this cannot be confirmed due to lack of imaging and visualization at the time the damage occurred.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.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: 23457672
• Report Number: 2015691-2025-09021
• Device Sequence Number: 13021746
• Product Code: NKM
• UDI-Device Identifier: 00690103216967
• UDI-Public: (01)00690103216967(17)260512(11)250512
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 12/17/2025

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: 05/12/2026
• Device Model Number: 20000GSA
• Device Lot Number: 66601269
• 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: 10/20/2025
• Supplement Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/12/2025
• 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: 84 YR
• Patient Sex: Female