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 Codes	Cardiac Tamponade (2226); Cardiac Perforation (2513); Hemodynamic instability (4868)
Date of Event	06/18/2024
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
Edwards received notification of a pascal in mitral position where there was subvalvular growing effusion noted.The procedure was aborted for pericardial drain.It was unknown if the effusion came from the wire or the introducer.Mid-procedure there was growing effusion noted.The patient required additional hemodynamic support.Pericardial drain was placed, and cell saver transfusion occurred.The patient was given 40mg of protamine.The cause was unknown- likely due to the wire in appendage or introducer near the appendage.The effusion was first noticed when steering down to the valve.The patient required increasing amount of hemodynamic support for blood pressure.It led to cardiac tamponade and a pericardial drain was placed.As per medical opinion, the perceived root cause of the event was puncture to the left atrial appendage.The patient remained in the hospital overnight, reversal of heparin with protamine, and the drain was removed next day.
Additional Manufacturer Narrative
The complaint for difficult/unable to insert device into transseptal puncture location was confirmed with other empirical evidence as confirmed by the edwards clinical specialist present at the case.Available information suggests that procedural and patient factors may have contributed to this event.Procedural factors include loss of imaging and placement of guidewire close to anatomy during device insertion which may have contributed to the effusion that resulted in atrial/septal wall damage.Additionally, patient factors include frail tissue which creates an environment that is more sensitive to device interaction that can lead to atrial/septal wall damage.
Additional Manufacturer Narrative
The following sections were updated/corrected/added: b4, g3, g6, h2, h6 and h11.This is a supplemental report to correct the h6 impact code.

• 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: 19722607
• Report Number: 2015691-2024-05273
• Device Sequence Number: 8327786
• Product Code: NKM
• UDI-Device Identifier: 00690103216967
• UDI-Public: (01)00690103216967(17)250115
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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,Followup
• Report Date (Section B): 08/13/2024

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: 01/15/2025
• Device Model Number: 20000GSA
• Device Lot Number: 65530400
• 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: 06/18/2024
• Supplement Date Received by Manufacturer: 07/11/2024; 08/12/2024
• Initial Report FDA Received Date: 07/11/2024
• Supplement Report FDA Received Date: 08/02/2024; 08/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/16/2024
• 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: Unknown