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

Model Number 20000ISM

Device Problems Entrapment of Device (1212); Patient Device Interaction Problem (4001)

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

Event Date 08/28/2023

Event Type  Injury  

Manufacturer Narrative

The event is captured by edwards lifesciences under complaint #: (b)(6)2023 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 precision ace procedure in mitral position where during procedure a leaflet tear occurred, and the procedure was aborted.Baseline was prolapse of the posterior mitral leaflet (pml) in segment p2/p1, mitral regurgitation (mr) grade 4 with eccentric jet and the strategy was to place a device directly in the prolapse.Preparation of the device was performed according to ifu.Device was placed above the prolapse and after clasp check and clocking, the device was closed crossing the valve.Device was opened and after slight retract of the implant catheter (ic), both leaflets were grasped together, and device was closed.Reduction of the mr was achieved from grade 4 to 2.However, in echo there was not an optimal result because an eccentric jet through the device appeared.Decision was made to change position and try a new grasp.After 3-4 attempts laterally and medially to the prolapse it did not show optimal results.A tear in the pml was then visible on echo.Several attempts to stabilize this with the device and to change to a two-device strategy failed.The decision was made to abort the procedure and the final grade of mr was slightly worse than before.As reported, the patient had rheumatoid arthritis and therefore the leaflets were very fragile.Patient remains stable and implanting physicians will discuss with the cardiac surgeons further therapy.

Manufacturer Narrative

The complaint for leaflet damaged while capturing was confirmed with other empirical evidence.No manufacturing non-conformities were found as a result of the complaint evaluation.Available information suggests that patient conditions (patient had rheumatoid arthritis and therefore the leaflets were very fragile) and procedure use (after 3-4 attempts laterally and medially to the prolapse it did not show optimal results; two-device strategy failed with sub-optimal result) 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: 17795451
• MDR Text Key: 324002071
• Report Number: 2015691-2023-16083
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 00690103213324
• UDI-Public: (01)00690103213324(17)240710
• 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: Initial,Followup
• Report Date: 10/17/2023

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 Model Number: 20000ISM
• Device Lot Number: 10969859
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/28/2023
• Initial Date FDA Received: 09/21/2023
• Supplement Dates Manufacturer Received: 10/13/2023
• Supplement Dates FDA Received: 10/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2023
• 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: 53 YR
• Patient Sex: Female
• Patient Weight: 80 KG