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

Model Number 20000ISM

Device Problem Malposition of Device (2616)

Patient Problem Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 01/24/2024

Event Type  Injury  

Event Description

Edwards received notification of a pascal precision ace in mitral position.2 months and 15 days after the initial mitral procedure, the patient underwent a concomitant pascal re-intervention to treat tricuspid regurgitation (tr) and recurrent mitral regurgitation (mr).At the initial procedure, two pascal ace devices were implanted in mitral position to treat a big prolapse in the lateral part of the valve and the result was from mr grade 4 to mr grade 1.There were reportedly no issues during the initial procedure.During the re-intervention, tr was treated with one pascal ace device in p1-s position without incidents.Starting tr was grade 3 and final tr was grade 1.Additionally, it was observed that the mr was potentially related to a leaflet tear and an orifice in the posterior leaflet in the area where the pascal was implanted.As per medical opinion, leaflet mobility could have caused the leaflet damage and there was no allegation against the device.The leak in the pml was treated with a vascular plug.The result was good and uneventful.The patient was in a good clinical condition.After further analyzing the anatomy and the case, as per physician's opinion, the recurrence of mr was not due to leaflet tearing.Their theory is that a pascal was placed in an area of a pml indentation and that a few days later after release part of the posterior paddle of the pascal got loose on that spot due to lack of tissue.This led to an increase in mobility of that device and then a regurgitant orifice leading to mr.This was not a tearing nor a full slda and this explained why they treated it with a plug.Physicians felt this was a pretty challenging case due to the anatomy and still felt good about both result and device safety.

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.

Manufacturer Narrative

The complaint for reduced therapeutic efficacy over time / incorrect implant position was confirmed with objective evidence via the imaging evaluation that determined a qualitatively increase in mitral regurgitation at baseline pre-procedure 3d en face with color doppler of the second intervention in comparison to the one obtained immediately post the first procedure.The device history record review was completed, and this device passed all manufacturing and sterilization inspections.There were no nonconformance related to this complaint event.Available information suggests that the initial placement of the implant over the pml indentation, leaflet capture at commissure and inadequate insertion may have contributed to the event.

• 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: 18739625
• MDR Text Key: 335809139
• Report Number: 2015691-2024-01160
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 00690103213324
• UDI-Public: (01)00690103213324(17)240828
• 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: 03/25/2024

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: 11183149
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/24/2024
• Initial Date FDA Received: 02/20/2024
• Supplement Dates Manufacturer Received: 03/22/2024
• Supplement Dates FDA Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2023
• 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