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

Model Number 20000ISM

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Asystole (4442)

Event Date 03/08/2024

Event Type  Injury  

Event Description

Edwards received notification of a pascal precision ace procedure in mitral position where during procedure, the patient became asystolic and a temporary pacemaker had to be implanted.The puncture and presentation of the guide sheath (gs) could be carried out without any problems.After steering down through the mitral valve, the patient became asystolic.As reported, the device did not touch the ventricle in any way.The decision was to insert a temporary pacemaker that was replaced by a mobile version after the procedure.As per the physician, the patient was already in a generally very poor condition before the procedure.A permanent pacemaker was being considered to be implanted in the next days after the procedure.The case was concluded very successfully.Starting mitral regurgitation (mr) grade was 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.

Event Description

Additional information received stated that the type of block was an av block and a permanent pacemaker was finally implanted since the patient was asystolic several times.

Manufacturer Narrative

The following sections were updated/corrected/added: b4, b5, b7, d4, g3, g6, h2, h6 and h11 the complaint for device interaction with conduction system was confirmed with other empirical evidence as confirmed by the edward clinical specialist present at the case.No manufacturing non-conformities were identified through the evaluation.Images were not provided for this event; therefore, an imaging evaluation could not be performed.Available information suggests that the patient poor condition prior to the procedure, including pre-existing atrial fibrillation, may have contributed to the adverse 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: 19020617
• MDR Text Key: 339125127
• Report Number: 2015691-2024-02490
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 00690103213324
• UDI-Public: (01)00690103213324(17)250101
• 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: 04/29/2024

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/08/2024
• Initial Date FDA Received: 04/02/2024
• Supplement Dates Manufacturer Received: 04/08/2024
• Supplement Dates FDA Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/02/2024
• 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 Sex: Male