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

Model Number 20000ISM

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cusp Tear (2656)

Event Date 03/06/2024

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.H3 other text : device remains implanted.

Event Description

Edwards received notification of a pascal precision ace procedure in tricuspid position where during the procedure, a leaflet tear occurred, and the procedure was aborted.Patient had tricuspid regurgitation (tr) grade 4, ef 52% with a gap of 6-7mm, main jet a-s and second jet p-s.Valve had mixed morphology fmr and a ruptured cord.The strategy was to place the device a-s relatively central.Device was inserted, but different positions and orientations were tried and there was no significant tr reduction achieved or there was splitting of the jet/created an eccentric jet.This was aggravated by a retracted septal leaflet and there was no chance to grasp both leaflets at the same time.Independent grasping was attempted which started with the lateral one and grasped the septal afterwards.Tension was visible in fluoro and echo on the system during the maneuver.Minimum 5-6 positions were tried with no significant tr reduction.During the last maneuver the lateral leaflet was captured, and it was tried to grasp the septal second.Tension was built up in the system by swinging to septal and then the catheter jumped.The tension was released from the system and the lateral leaflet detached.Ti appeared a little worse in the echo and a slight tear was visible on the posterior leaflet in the echo.At this point, the team decided to retrieve the system to avoid further manipulation.Retrieval of the system was done without complications.Patient was noted as to be in stable condition.Patient was going to be screened for evoque.

Manufacturer Narrative

The following sections were updated/corrected/added: b4, b5, g3, g6, h2, h6 and h11.The complaint for leaflet damaged while capturing was confirmed with empirical evidence based on the accounts by the edwards clinical specialist present during the procedure.Available information suggests patient anatomy and procedural complications likely contributed to the event due to these operational context factors potentially resulted in the event.Based on extensive complaint investigations, these 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/precision ifu and training materials provide adequate instructions on device usage and optimization prior to release.These events will continue to be monitored and complaints trending, and control limits are managed and assessed.

Event Description

Additional information received stated that the evoque procedure is planned on the (b)(6) 2024, to treat the patient.

• 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: 18988382
• MDR Text Key: 338730918
• Report Number: 2015691-2024-02353
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 00690103213324
• UDI-Public: (01)00690103213324(17)241219(11)231220
• 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: 04/15/2024

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: 03/06/2024
• Initial Date FDA Received: 03/27/2024
• Supplement Dates Manufacturer Received: 04/15/2024
• Supplement Dates FDA Received: 04/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2023
• 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
• Patient Age: 67 YR
• Patient Sex: Male