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

Model Number 20000IS

Device Problem Migration (4003)

Patient Problems Foreign Body Embolism (4439); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 04/05/2024

Event Type  Injury  

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 Description

Edwards received notification of a pascal precision procedure in mitral position where after the procedure, the device detached from both leaflets leading to embolization and was caught on the patient's aortic valve bioprosthesis.Upon release of the p10 implant, the posterior mitral leaflet (pml) came out of the device resulting in a single leaflet device attachment (slda).The pml was short (8mm), retracted and under tension.A second device was attempted to stabilize the first device implanted, but it was not possible due to inadequate pml insertion.After the procedure, the device embolized and got caught on the patient's aortic valve bioprosthesis.On post-procedure day 6, the device was safely snared and removed with no patient complications.The patient was not symptomatic due to the embolization.However, mitral regurgitation (mr) was still graded as severe.There were no plans to reintervene the patient.

Manufacturer Narrative

The complaint for implant detaches from both leaflets into vasculature (post procedure) was confirmed with other empirical evidence.No manufacturing non-conformities were identified from the investigation.There was no allegation or indication a device malfunction contributed to this adverse event.As imaging was not provided for review, an imaging evaluation could not be performed.Available information suggestions operational context (the posterior mitral leaflet (pml) was short.Both the pml and aml (anterior mitral leaflet) were under tension and calcified.Numerous grasps were attempted and once thought to have sufficient leaflet insertion, decision was taken to continue with release.Prior to release of actuation wire (aw), the pml had come out of the implant) likely contributed to the reported 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: 19215802
• MDR Text Key: 341422511
• Report Number: 2015691-2024-03243
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 00690103213317
• UDI-Public: (01)00690103213317(17)241018(11)231019
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 04/30/2024

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: 20000IS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/05/2024
• Initial Date FDA Received: 04/30/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/19/2023
• 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