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

Model Number 20000ISMCL

Device Problem Malposition of Device (2616)

Patient Problem Tricuspid Valve Insufficiency/ Regurgitation (4453)

Event Date 09/13/2021

Event Type  Injury  

Event Description

Edwards received notification of a pascal in tricuspid position where there was massive tricuspid annular dilatation with malcoaptation, septal leaflet tethering.The clasp device was partially on the leaflets and were removed.

Manufacturer Narrative

The event is captured by edwards lifesciences under complaint #: (b)(4).Based on the image evaluation findings this device was also contributory to the event- leading to high residual tr.The device was removed.This mdr is linked to a previous one under mfr report number 2015691-2023-15051 which is for the same patient.Also, this is an initial + final combined mdr report.The complaint for reduced therapeutic efficacy over time / incorrect implant position was confirmed with objective evidence.No manufacturing non-conformities were identified from the imaging evaluation.Based on the imaging evaluation, residual tr post-procedure is semi-quantitatively severe after the implantation of two pascal ace devices with an untreated central valve regurgitation.Possible contributing factors to the high residual tr include procedural related issues and positioning of the ace devices leaving the largest central tr jet untreated.Available information suggests that patient conditions including a large flail segment may have contributed to the reported event.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, addressing degenerative mitral regurgitation.Therefore, deployment in the tricuspid position is considered off-label.

• 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: 17777783
• MDR Text Key: 323785523
• Report Number: 2015691-2023-16046
• Device Sequence Number: 1
• Product Code: NKM
• 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: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/19/2023

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 Expiration Date: 10/28/2021
• Device Model Number: 20000ISMCL
• Device Lot Number: 63780922
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/29/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention