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

Model Number 20000ISM

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Rupture (2208); Tricuspid Valve Insufficiency/ Regurgitation (4453)

Event Date 12/12/2023

Event Type  Injury  

Event Description

Edwards received notification of a pascal precision ace procedure in tricuspid position where during the procedure, a chord rupture was detected.There were some dense chords but not affecting the grasping area and during the pre-procedure echo assessment nothing concerning regarding chords was detected.There were no difficulties grasping/capturing leaflets.During the first device implantation, an optimization of the lateral leaflet was performed and then device was moved to the septal leaflet to grasp it.After this movement and closing the pascal ace, it was realized that there was a flail in the lateral part.After assessing it was confirmed that a chord was ruptured that initially was not damaged.After that the strategy was changed and it was managed to target the flail and reduce the tricuspid regurgitation (tr) with an additional device.As per the clinical specialist, strategy started with one device without knowing if a second would be needed, but after the rupture a second device was needed.Starting tr was severe 4+ and post-procedural was moderate 2+.

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.It should be noted, the device was implanted in the tricuspid position.At this time, the pascal precision transcatheter valve repair system is only indicated for the native mitral valve in the us, addressing degenerative mitral regurgitation.But, it is approved for both tricuspid and mitral spaces in the region where the procedure was performed.Therefore, deployment in the tricuspid position will not be considered off-label in this case.Implanted.

Manufacturer Narrative

The reported chordae damaged during leaflet capture event does not allege a malfunction that could be related to an edwards manufacturing deficiency, and one was not able to be confirmed through investigation.The device history record review was completed, and this device passed all manufacturing and sterilization inspections.There are no nonconformances identified related to the complaint event.The presence of the chordae rupture as described in the complaint event was confirmed by other empirical through account by the edwards clinical specialist present during the procedure.Based on the information available, a definitive root cause is not able to be determined.

• Brand Name: EDWARDS PASCAL PRECISION
• Type of Device: 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: 18438689
• MDR Text Key: 331864741
• Report Number: 2015691-2024-00031
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 00690103213324
• UDI-Public: (01)00690103213324(17)240821
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P220003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/24/2024

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
• Device Operator: Health Professional
• Device Model Number: 20000ISM
• Device Lot Number: 11154784
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/12/2023
• Initial Date FDA Received: 01/03/2024
• Supplement Dates Manufacturer Received: 01/23/2024
• Supplement Dates FDA Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention