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

Model Number 20000ISM

Device Problem Activation Failure (3270)

Patient Problems Chest Pain (1776); Fatigue (1849); Tricuspid Valve Insufficiency/ Regurgitation (4453)

Event Date 03/13/2024

Event Type  Injury  

Manufacturer Narrative

The event is captured by edwards lifesciences under complaint#: (b)(4).This is a combined initial + final report with investigation findings included.This is mdr 2 of 2 since there were a total of 2 devices that had the slda.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.The complaint for implant dislodged from a single leaflet, single leaflet device attachment (slda) post procedure was unable to be confirmed based on limited information received.Evaluation of the available information is unable to identify a potential root cause for this event.Based on extensive complaint investigations, the root cause for slda events are most likely due to patient factors, procedural factors, imaging factors, or a combination of these factors and are not attributed to device malfunctions or manufacturing nonconformances.The pascal and pascal precision ifu and training materials provide adequate instructions on device implant, leaflet capture, and optimization prior to release.These events will continue to be monitored and complaints trending and control limits are managed and assessed.

Event Description

Edwards received notification of a pascal precision ace procedure in tricuspid position where after an unknown implant duration, a single leaflet device attachment (slda) occurred in both pascal ace devices implanted.Devices were implanted in antero-septal position.The first ace detached from the anterior leaflet and the second ace detached from the septal leaflet.Patient experienced reduced exercise capacity and thoracic pain, whereupon the slda was diagnosed.Four months after the index procedure, patient was treated with 3 additional non-edwards devices.

Manufacturer Narrative

Additional information received from the clinical specialist stated that the physician cannot say when the slda happened.It was recognized end of january.Hence, the event date will be unknown.

• 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: 19084143
• MDR Text Key: 339877677
• Report Number: 2015691-2024-02743
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 00690103213324
• UDI-Public: (01)00690103213324(17)241008(11)231009
• 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: 04/19/2024

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: 11332081
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/14/2024
• Initial Date FDA Received: 04/10/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/19/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/09/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention