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 03/08/2024

Event Type  Injury  

Event Description

Edwards received notification of a pascal precision ace procedure in tricuspid position where the patient was treated with three devices in the a-s commissure and the tricuspid regurgitation (tr) was moderate.One day after the procedure the patient had more tr than normal, and the physicians scheduled to treat the patient again in order to reduce the tr more.The day of the reintervention (4 days after index procedure) it was observed that the third device pascal device implanted had an slda (single leaflet device attachment).The patient was treated with additional pascal precision ace and the result was evaluated as mild by the echocardiographer.During the first procedure, imaging was difficult, even more so for the last device that finally had the late slda.Grade of regurgitation at baseline was torrential and tr was severe to massive the day of the second procedure.

Manufacturer Narrative

The event is captured by edwards lifesciences under complaint #: (b)(4).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) was confirmed with other empirical evidence based on information provided by the clinical specialist.Available information suggests imaging factors 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: 19020771
• MDR Text Key: 339127627
• Report Number: 2015691-2024-02487
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 00690103213324
• UDI-Public: (01)00690103213324(17)250131(11)240201
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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
• Report Date: 04/02/2024

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: 03/08/2024
• Initial Date FDA Received: 04/02/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/01/2024
• 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