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 Perforation (2513); Hemodynamic instability (4868)
Date of Event	03/21/2024
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 one implant had chordal entanglement and then was aborted.Another implant was then used which led to an actuation wire break during procedure, but the device was successfully removed without patient injury.This device was also aborted due to the wire break.It was able to bailout safely and replace both guide and ace with a new system.A third new device was then successfully implanted.Additional information received stated that the device was under a lot of tension due to the fact that the team were interacting with so many chordae.It was noticed there was an issue when the device looked as if it was disconfigured with different paddle flexing.Initially it was thought that the device had an issue but then the actuation wire break was noticed.There was a residual bidirectional shunt and the patient had hemodynamic instability.The shunt was closed off during the initial procedure itself.The procedure was completed successfully, and mr was reduced from severe to mild.
Additional Manufacturer Narrative
The following sections were updated/corrected/added: b4, d4, g3, g6, h2, h6 and h11.The complaint for difficult/unable to insert device into transseptal puncture location was confirmed with other empirical evidence.No manufacturing non-conformities were identified from the imaging evaluation.There was no allegation of product malfunction reported.Furthermore, a device history record review was completed, and this device passed all manufacturing and sterilization inspections.No nonconformances related to the complaint event were identified.Available information suggests that procedural context (there appears to be some tension on the second ace device implant and catheter system) and patient conditions (patient had hemodynamic instability) likely contributed to the adverse event.The imaging evaluation noted a bidirectional shunt after the third device was successfully placed.The first and second device were noted to be successfully bailed out.However, a definite root cause 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: 19144456
• Report Number: 2015691-2024-03016
• Device Sequence Number: 7800455
• Product Code: NKM
• UDI-Device Identifier: 00690103216967
• UDI-Public: (01)00690103216967(17)241128
• 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: 2024
• 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): 06/05/2024

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: 11/28/2024
• Device Model Number: 20000GSA
• Device Lot Number: 65315919
• 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: Not provided
• Supplement Date Received by Manufacturer: 04/23/2024; 06/01/2024
• Initial Report FDA Received Date: 04/19/2024
• Supplement Report FDA Received Date: 05/15/2024; 06/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/29/2023
• 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