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	01/22/2026
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 the implant was opened but not attempted.During the procedure, when the gs (guide sheath) was introduced and the pascal device introduced into the gs, a pericardial effusion was noticed which progressed to cardiac tamponade.There was no effusion / cardiac tamponade noted before the insertion of the gs.During transseptal procedure, the wire was noted as difficult to advance, and the team could not confirm where they were (lupv vs rupv).Imaging was also difficult as ic was instructed to go more posterior, and a puncture was made through the septal trigone.Pericardiocentesis was performed.Patient was then surgically opened, and in surgery, bleeding had stopped requiring no surgical repair, only evacuation of the clotted material.The pascal procedure was aborted.The mr (mitral regurgitation) remained severe.The patient is stable.A plan for reintervention is unknown.
Additional Manufacturer Narrative
The following sections were updated/corrected/added: b4, d4, g3, g6, h2, h4, h6, and h11.H6 type of investigation: labelling review.The complaint for inability or difficulty to insert device into transseptal puncture location was confirmed.Available information suggests during this mitral procedure a pericardial effusion was noticed which progressed to cardiac tamponade and there was no effusion / cardiac tamponade noted before the insertion of the gs.Through the procedure there was difficult imaging throughout the case and difficulties noted during device insertion.Both factors could have contributed to puncturing of the atrial wall during the transeptal puncture though this was unable to be confirmed.The patient was noted to be in stable condition, although the procedure had to be aborted for surgical intervention to remove the clotted material.In this specific event, it is not possible to identify what exactly lead to the effusion.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: 24210211
• Report Number: 2015691-2026-10636
• Device Sequence Number: 18547829
• Product Code: NKM
• UDI-Device Identifier: 00690103216967
• UDI-Public: (01)00690103216967(17)261112(11)251112
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 03/17/2026

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 Model Number: 20000GSA
• Device Lot Number: 67205003
• 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: 01/22/2026
• Supplement Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 01/29/2026
• Supplement Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/12/2025
• 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: 77 YR
• Patient Sex: Male