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

Model Number 20000ISM

Device Problem Activation Failure (3270)

Patient Problem Tricuspid Valve Insufficiency/ Regurgitation (4453)

Event Date 04/02/2024

Event Type  Injury  

Manufacturer Narrative

The event is captured by edwards lifesciences under complaint (b)(4).B2: other serious- even though there was no reintervention, there is a potential for reintervention in this case.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 an slda (single leaflet device attachment) happened.The tricuspid regurgitation (tr) was 4+ at baseline.The pacemaker lead was attached to the middle of septal leaflet.The strategy was to put two ace devices on both sides of the lead.The first ace was prepared and steered to the valve.After position and trajectory, the ace was positioned in a-s near to the lead.The insertion was controlled in rv in/out flow and in tg.Directly after releasing, the slda was seen as the septal leaflet was detached.The second ace was placed in p-s segment to reduce the tr without any problems.The third ace was placed in a-s commissure to stabilize the detached one.The end gradient was 2.5 and the tr reduction was from 4+ to 3+.As per medical opinion the cause of the slda could be that the pacemaker lead was attached to the middle part of the septal leaflet.The strategy was to implant two pascal ace devices from both side of the lead.The team's opinion is that they were too close to the lead and probably did not have enough leaflet captured.

Manufacturer Narrative

The complaint for single leaflet device attachment (slda) was confirmed with empirical evidence based on information provided by the clinical specialist.Available information suggests procedural factors likely contributed to the event due to presence of a pacemaker lead in the intended grasping location making adequate grasping difficult.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.

• 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: 19191843
• MDR Text Key: 341148586
• Report Number: 2015691-2024-03175
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 00690103213324
• UDI-Public: (01)00690103213324(17)241119(11)231120
• 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: 04/30/2024

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: 20000ISM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/02/2024
• Initial Date FDA Received: 04/26/2024
• Supplement Dates Manufacturer Received: 04/29/2024
• Supplement Dates FDA Received: 04/30/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/20/2023
• 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): Other