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

Model Number 20000ISM

Device Problem Positioning Failure (1158)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/21/2024

Event Type  malfunction  

Event Description

Edwards received notification of a pascal precision ace procedure in mitral position where during the procedure, there was a lot of tension in the system leading to delayed device movement.The decision was to bailout, but it was difficult because it was not possible to fully elongate the device.During device preparation and at the beginning of the procedure there were no issues detected with performance of the device.Transseptal puncture was challenging but was in a suitable position.There were difficulties during device insertion, with higher tension noted.There was vessel tortuosity at the level of the patient's hip.On echo, the team realized the axis of the heart had changed and was different than normal.No unusual structure in the heart or contact with chords/anatomy was noted.The device was not responding normally to clocking maneuvers, and rough movements were performed on the catheters, due to the catheters not reacting in the usual way.Crossing the valve caused a massive lowering of the heart pressure, so it was needed to restart, and change positioning and trajectory above the valve.No changes in ecg or signs of conduction disturbances were observed during procedure.Delayed reaction of the device continued when maneuvering due to a lot of tension in the systems.The movements of the catheter were no longer meeting expectations and therefore the decision was made to bailout the device.However, full elongation was not possible, only to diamond configuration.After excessive force, the system could be pulled into the guide sheath enough for a successful bail out.There was no patient anatomy damage noted after bailing out.There was a visible defect on the implant catheter (ic) observed after removal.A new system was used with two implants placed.Starting mitral regurgitation (mr) grade was 3/4+, and final mr grade was 1.

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.

Manufacturer Narrative

The following sections were updated/corrected/added: b4, g3, g6, h2 and h11.New product evaluation findings stated that when the implant was elongated with the clasps down, there was separation of the finger component from the catheter shaft.

• 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: 19115684
• MDR Text Key: 340571230
• Report Number: 2015691-2024-02870
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 00690103213324
• UDI-Public: (01)00690103213324(17)241127(11)231128
• 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: 05/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20000ISM
• Device Lot Number: 11463435
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/21/2024
• Initial Date FDA Received: 04/16/2024
• Supplement Dates Manufacturer Received: 04/19/2024
• Supplement Dates FDA Received: 05/14/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/28/2023
• 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 Age: 82 YR
• Patient Sex: Female