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

Model Number 20000ISM

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Stroke/CVA (1770); Thrombosis/Thrombus (4440)

Event Date 01/19/2024

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.

Event Description

Edwards received notification of a pascal precision ace procedure in mitral position.During procedure, a small thrombus was observed via trans-oesophageal echocardiogram (toe) attached to the tip of the implant when steering down to the valve.Before procedure, thrombus on the right access site for the central line was observed.Therefore, the decision was to change to left side to get successful access.However, sludge in the left atrial appendage was observed.During intervention, a p10 had to be retrieved as it was not possible to successfully grasp the posterior mitral leaflet (pml) due to dense chordae.As reported, the physician did not want to change the guide sheath (gs) to avoid the risk of disturbing the sludge in the appendage with a wire to secure the transseptal access.The p10 was bailed out successfully and the ace was prepared and introduced instead.When steering down to the valve, a small thrombus like structure was observed at the tip of the ace via toe.It was decided to proceed with the procedure under heavy heparinization of the patient (act 400).Act was controlled every 15 minutes during the entire procedure and was never under 250.As reported, there was no different treatment than heparinization during the procedure.Procedure went successfully and without further incidents.Thrombus was not observable anymore after implantation.Two hours after the procedure, patient was reported to have stroke symptoms and was under treatment by the neurologic department.Thrombus was successfully removed by the treatment.Planned treatment for the stroke was thrombectomy, however it is not confirmed if it was needed in the end.Patient was reported to be stable, was brought back to cardiologic station and planned to be extubated the same day.

Manufacturer Narrative

The following sections were updated/corrected/added: b4, b5, g3, g6, h2 and h10.

Event Description

Additional information received as per internal imaging evaluation review, starting mitral regurgitation (mr) grade was 4 and final mr grade was 1.

Manufacturer Narrative

The complaint for thrombus formation was confirmed- other empirical evidence based on the accounts of the edwards clinical specialist present during the procedure.Available information suggests the procedural complications likely contributed to the event due to challenges encountered during implant delivery such as the described sludge and dense chords.Based on extensive complaint investigations and reviews, it has been identified that events are not associated with device malfunctions or manufacturing nonconformances.Per the instructions for use (ifu), intracardiac thrombus formation and device thrombosis are known potential adverse events which have been identified as possible complications associated with standard cardiac catheterization procedures.Potential patient risk factors such as atrial fibrillation, systemic disease (e.G., systemic lupus erythematosus, inflammation, and damage to various body tissues, including joints, skin, kidneys, heart, lungs, blood vessels, and brain), valvular disease itself and reduced cardiac ejection fraction can contribute to increased risk of thrombus/thrombosis.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: 18697023
• MDR Text Key: 335297379
• Report Number: 2015691-2024-00970
• 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: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Followup,Followup
• Report Date: 02/27/2024

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: 11459002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/13/2024
• Supplement Dates Manufacturer Received: 02/27/2024; 02/27/2024
• Supplement Dates FDA Received: 02/27/2024; 02/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/23/2023
• 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): Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male