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

Model Number 20000ISMA

Device Problem Activation Failure (3270)

Patient Problems Cusp Tear (2656); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 01/08/2024

Event Type  Injury  

Manufacturer Narrative

The event is captured by edwards lifesciences under complaint #: (b)(4).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.

Event Description

Edwards received notification of a pascal in mitral procedure where the first pascal implant was implanted after multiple capture attempts.A 2nd implant (ace) was attempted and the pml detached from the implant during suture removal.The aml suture had already been successfully removed when the pml tear occurred.As the pml suture was being removed, the echo physician noticed a significant increase in mr, and the procedure was paused to review imaging.After an intensive review and discussion by all team members, an slda along with a tear of the pml was noticed.There had been no tension on either suture during removal, and it is unclear exactly what caused the leaflet tear per the physician.Hypothesis is that either a patient anomaly or previous grasp attempts with the implanted p10 device could have contributed to the tear.The device was bailed out using advanced bail out techniques.The physician decided to not place another device, and the p10 that was implanted was found to be in good position at the end of the procedure.Mr at baseline was 2 moderate, but after the procedure was 3 moderate to severe.Per call with clinical specialist, after the first p10 implant, the mr reduced to 2 moderate, but after the slda/ leaflet tear, the patient left with the same hemodynamics and regurgitation grade as they had presented with (moderate-severe).No plans for reintervention at this time.The plan is to let the leaflet tissue heal and reassess in the future.

Manufacturer Narrative

The complaint for implant dislodged from a single leaflet, single leaflet device attachment (slda) was confirmed empirically based on observations made by the clinical specialist.Available information suggests potential contributing factors are patient and procedural related.Patient related may have been a patient anomaly due to a pml tear confirmed during imaging review post slda confirmation.Procedural related was multiple grasping attempts and indication of significant increase in mr during suture removal may have contributed to the slda.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: 18610706
• MDR Text Key: 334142501
• Report Number: 2015691-2024-00662
• Device Sequence Number: 1
• Product Code: NKM
• 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: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/28/2024

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: 20000ISMA
• Device Lot Number: 11381910
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/08/2024
• Initial Date FDA Received: 01/30/2024
• Supplement Dates Manufacturer Received: 02/28/2024
• Supplement Dates FDA Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2023
• 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