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

Model Number 20000ISMCL

Device Problem Malposition of Device (2616)

Patient Problem Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 04/25/2023

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.H3 other text: not returned.

Event Description

Edwards received notification of a pascal in mitral position where the patient underwent coronary artery bypass graft surgery with mitral valve replacement.Transcatheter edge to edge repair (teer) devices were removed.After review of procedural and serial follow up echocardiograms, there were two pascal ace devices implanted.The first pascal ace device appeared mobile and semi-stable due to the hypermobility of the posterior leaflet throughout the cardiac cycle which was suggestive of suboptimal posterior leaflet grasping.The second pascal ace device implant was stable.Residual mr was mild to moderate qualitatively.Serial follow-up echocardiograms demonstrated consistent findings of device stability, gradients, and residual mr.Possible contributing factors to the device mobility without evidence of slda included patient related (large flail segment).

Manufacturer Narrative

The following sections have been added/updated/corrected: b4, d4, g3, g6, h2, h4, h6 and h10.The complaint for reduced therapeutic efficacy over time / incorrect implant position was confirmed with objective evidence.No manufacturing non-conformities were identified from the imaging evaluation.Available information suggests that patient conditions including a large flail segment may have contributed to the reported event.

• 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: 17213581
• MDR Text Key: 317983986
• Report Number: 2015691-2023-14187
• 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: 07/26/2023

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 Expiration Date: 01/14/2022
• Device Model Number: 20000ISMCL
• Device Lot Number: 63874741
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/01/2023
• Initial Date FDA Received: 06/27/2023
• Supplement Dates Manufacturer Received: 07/24/2023
• Supplement Dates FDA Received: 07/26/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/16/2021
• 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
• Patient Weight: 74 KG