MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EVOQUE TRICUSPID VALVE REPLACEMENT SYSTEM; PERCUTANEOUSLY DELIVERED PROSTHESES AND TRICUSPID VALVES

Model Number	9850EV52US
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Heart Block (4444)
Date of Event	04/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Event or Problem Description
Edwards received notification of an evoque in tricuspid position where following induction by anesthesia, the patient heart rate was generally in the 60-50s, but regularly dipped into the high 40s.Patient heart rate prior to anesthesia was not disclosed to the edwards team.Following successful deployment of valve, the patient heart rate was regularly in the high 30s, however never lost hemodynamic stability.Final valve deployment position was- anterior was slightly lower than posterior/septal/lateral (around 4-6mm).Implanting team believed this change in rate to be heart block and elected to cross new evoque valve with temporary pacing wire and observe.Per the physician, the root cause of the event was anchor contacting the septum.Per latest information, the patient went for a permanent pacemaker with cs lead.Currently in-patient and on dobutamine drip.
Additional Manufacturer Narrative
Additional h6 type of investigation code: labelling review.The complaint for valve interacts with conduction system was confirmed with other empirical evidence via information reported by edwards clinical specialist.No manufacturing non-conformities was found during dhr review.Since no edwards defect was identified, corrective or preventative actions are not required.A definite root cause is unable to be determined.Per the instructions for use (ifu), conduction system disturbance and/or heart block which may require treatment (including permanent pacemaker) are potential adverse events.Heart block and other conduction disturbances are common in patients with underlying cardiovascular disease and can be exacerbated or aggravated with standard intra-operative medications or anesthesia.Such events are related to the patient's underlying condition.Other mechanisms for conduction abnormalities could be related to coronary obstruction due to air embolism, coronary spasm and/or local edema affecting the av node.Conduction disturbances have also been documented during transcatheter cardiac procedures as a result of direct interaction with cardiac anatomy, especially in patients with underlying conduction abnormalities.Other potential causes include trauma by a guidewire or delivery system.

• Brand Name: EVOQUE TRICUSPID VALVE REPLACEMENT SYSTEM
• Common Device Name: PERCUTANEOUSLY DELIVERED PROSTHESES AND TRICUSPID VALVES
• 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: 21922980
• Report Number: 2015691-2025-03350
• Device Sequence Number: 8729312
• Product Code: NPW
• UDI-Device Identifier: 00690103217469
• UDI-Public: (01)00690103217469(17)261023(11)241023
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P230013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2025

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
• Operator of Device: Health Professional
• Device Model Number: 9850EV52US
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2025
• Supplement Date Received by Manufacturer: 06/02/2025
• Initial Report FDA Received Date: 04/28/2025
• Supplement Report FDA Received Date: 06/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/23/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female