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 Heart Block (4444)

Event Date 03/08/2024

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.It should be noted, the device was implanted in the tricuspid position.At this time, the pascal precision transcatheter valve repair system is only indicated for the native mitral valve in the us, addressing degenerative mitral regurgitation.But, it is approved for both tricuspid and mitral spaces in the region where the procedure was performed.Therefore, deployment in the tricuspid position will not be considered off-label in this case.

Event Description

Edwards received notification of a pascal precision ace procedure in tricuspid position where during the aborted procedure, a drop of heart rate (hr) led to bradyarrhythmia (20 hr) and progressed to atrioventricular (av) bundle block grade 3.The procedure was aborted, and the patient received a temporary pacemaker.The ace device was in capture ready position when trying to grasp the extremely tethered septal leaflet.During discrete grasping of the septal leaflet without any tension or force, the pascal ace must have got in contact with the right ventricular septal wall leading to deterioration of the conduction system.Hr dropped and the patient experienced bradyarrhythmia.Medication (betablocker) was provided to raise the hr.There was no further contact of the ace with the septum, but the ventricle did not pump regularly as seen in echo.No air embolism was visible in echo.The patient progressed to av bundle block grade 3.It was decided to bail out the pascal and a temporal pacemaker was implanted.Patient was transferred to icu/imc for further surveillance.Patient had pre-existing av bundle block grade i and hr before the event was 60 bpm.As per the physicians, the myocardium looked unusual as it had some irregular density.The pascal device was not blamed for this incident.Afterwards, it was not necessary for the patient to receive a permanent pacemaker.The physician said they stopped the betablocker medication and everything was good.Ten days after the procedure, patient underwent repair with pascal.Final tricuspid regurgitation (tr) grade was 2.No conduction disturbances occurred during the procedure.

Event Description

Additional information received stated that the baseline tricuspid regurgitation was torrential.The eroa went from 1cm^2 to 0.2cm^2.

Manufacturer Narrative

The following sections were updated/corrected/added: b4, b5, d4, g3, g6, h2, h6 and h11.The complaint for device interaction with conduction system was confirmed with other empirical evidence as confirmed by edwards 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 interaction of the implant with the right ventricular septal wall during septal leaflet capture, along with the pre-existing av bundle block grade i and myocardium density irregularity 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: 19042246
• MDR Text Key: 339436584
• Report Number: 2015691-2024-02558
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 00690103213324
• UDI-Public: (01)00690103213324(17)250123
• 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: 05/02/2024

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: 04/04/2024
• Supplement Dates Manufacturer Received: 05/01/2024
• Supplement Dates FDA Received: 05/02/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/25/2024
• 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 Age: 79 YR
• Patient Sex: Female