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 02/27/2024

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.H3 other text : not returned.

Event Description

Edwards received notification of a pascal precision ace procedure in tricuspid position where one day after the procedure, a single leaflet device attachment (slda) occurred.In the pre-echo images, the largest gap was observed to measure 12 mm.Anterior leaflet had indentation, and posterior leaflet had two scallops and septal leaflets were tethered.During procedure, maneuvers from steerable catheter (sc) were severely restricted due to a kinking vessel.Additionally, the echo images were very poor.As reported, it was not possible to grasp both leaflets anterior-septal, but posterior (p1)-septal.The assessment was very difficult, as it was not clear how securely the septal leaflet was grasped.However, the physician decided to release the pascal.Starting tricuspid regurgitation (tr) grade was 4+, and final tr grade was 1+.Patient was doing well after the procedure and was expected to be discharged home one day after.As reported during investigation, patient was planned to attend the clinic one-month post-procedure to receive further treatment probably with abbott.The tr after the slda went back up to 4 (same as baseline).

Manufacturer Narrative

The complaint for implant dislodged from a single leaflet, single leaflet device attachment (slda) was confirmed with other empirical evidence based on information provided by the clinical specialist and physician.Available information suggests patient factors (i.E., kinking vessel, anterior leaflet with indentation, posterior leaflet had two scallops and septal leaflets were tethered) and difficult echo imaging likely contributed to the 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.

• 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: 18965545
• MDR Text Key: 338430646
• Report Number: 2015691-2024-02256
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 00690103213324
• UDI-Public: (01)00690103213324(17)241210(11)231211
• 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: 03/26/2024

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: 02/27/2024
• Initial Date FDA Received: 03/23/2024
• Supplement Dates Manufacturer Received: 03/26/2024
• Supplement Dates FDA Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention