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

Model Number 20000ISM

Device Problem Activation Failure (3270)

Patient Problems Mitral Valve Insufficiency/ Regurgitation (4451); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/20/2023

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.H6 clinical code: intraoperative cardiac valve injury.The complaint for implant dislodged from a single leaflet, single leaflet device attachment (slda) post procedure was confirmed with other empirical evidence based on the accounts by the edwards clinical specialist.Available information suggests that challenging patient anatomy and procedural complications 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.H3 other text : device remains implanted.

Event Description

Edwards received notification of a pascal precision ace procedure in mitral position where there was a post procedure late single leaflet device attachment (slda).Two devices were implanted but the second implant had a posterior detachment.As per medical opinion, the cause of the slda could be that, when placing the second ace in the prolapse of the lateral commissure, the device was not lateral enough.As reported, there were a lot of difficulties getting more lateral probably also due to interaction with the annulus and or chordae, and grasping was difficult.Physician reviewed the images after the late slda and considered some minor chordae were probably grasped and were torn.After release there was a worsening of jet from mitral regurgitation (mr) grade 1 to mr grade 2.Starting mr was grade 4, post-procedural grade 2 and when the slda happened grade 4.There were no further plans 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: 18640305
• MDR Text Key: 334543871
• Report Number: 2015691-2024-00774
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 02/05/2024

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
• Device Lot Number: 11280259
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/23/2024
• Initial Date FDA Received: 02/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2023
• 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: 78 YR
• Patient Sex: Male