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

Model Number 20000ISM

Device Problem Activation Problem (4042)

Patient Problem Tricuspid Valve Insufficiency/ Regurgitation (4453)

Event Date 03/21/2024

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.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.

Event Description

Edwards received notification of a pascal precision ace procedure in tricuspid position where during procedure, there was a loss of leaflet capture of the posterior mitral leaflet (pml) and the decision was to bailout.Patient had challenging anatomy with 3 posterior scallops and 2 septal scallops, and a massive tethered septal leaflet.The first two devices could be released in the anterior-septal (a-s) position.After several grasping maneuvers of the septal leaflet, a third device could be placed posterior-septal (p-s) central with a 3-9 orientation.Due to the poor images during the grasping scenario, an intensive assessment of leaflet insertion in right ventricle (rv) in/out flow, reversed 4ch and trans-gastric short axis with x plan was done.Leaflet optimization was not considered to be needed, as it was it was observed that the posterior leaflet stayed stable up to the apex in systole and diastole.It was decided to release the third device, beginning with the septal leaflet.After pulling out the septal suture, with no tension noted and a reassessment was done.At that moment, the posterior leaflet was suddenly detached.The decision was to retrieve the third device without clasp control according to the troubleshooting guidelines and it was possible to bail out the system successfully.The intense following echo-assessment showed no pericardial effusion or any deviation from the initial status of the morphology after the first two devices.As reported, the device was probably placed in an indentation between p1-p2.There were only difficulties to grasp the tethered septal leaflet.The physician was convinced to choose the best spot for the third device.A guide sheath (gs) changing was refused, so the main physician decided to treat the residual tr (tricuspid regurgitation) at a later date after the epithelium had grown up over the first two devices.Starting tricuspid regurgitation (tr) grade was 5+, and post-procedural tr grade was 3+.

Manufacturer Narrative

The complaint for loss of capture during the release was confirmed with other empirical evidence via clinical specialist observation.No manufacturing non-conformities were identified during the procedure and no product was returned for evaluation.Based on provided information, there is an indication that patient condition contributed or caused the loss of capture event.It was noted that suture removal forces were normal during implant release.There were difficulties with grasping, and it is possible that the device was placed in an indentation between p1-p2.However, due to a limited amount of information, a definitive root cause is unable to be determined.

Manufacturer Narrative

The complaint for loss of capture during the release was confirmed with objective evidence via imaging evaluation.No manufacturing non-conformities were identified during the procedure and no product was returned for evaluation.Available information suggests that patient conditions may have contributed to the reported event, but a definite root cause is unable 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: 19117255
• MDR Text Key: 340289914
• Report Number: 2015691-2024-02878
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 006901313324
• UDI-Public: (01)006901313324(17)250122
• 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,Followup,Followup
• Report Date: 07/23/2024

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: 11719070
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/21/2024
• Initial Date FDA Received: 04/16/2024
• Supplement Dates Manufacturer Received: 05/13/2024; 05/16/2024; 07/23/2024
• Supplement Dates FDA Received: 05/15/2024; 05/21/2024; 07/23/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/23/2024
• 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
• Patient Age: 85 YR
• Patient Sex: Female