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

Model Number	9850TDSUS
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Arrhythmia (1721)
Date of Event	01/19/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer's investigation is ongoing and a follow-up report will be submitted when the investigation is complete.
Event or Problem Description
Edwards received notification of a transcatheter tricuspid valve replacement (ttvr) procedure involving the evoque system.Rv lead dislodgement was noted 1 hour post deployment of the valve.There was no patient injury related to an ew device during the procedure.The lead dislodged was noted by the failure to capture observed on the telemetry monitor post op.A screw was placed in the lead and then ultimately a permanent pacemaker was placed.The patient is doing well.The patient was not rv lead dependent.Screening showed minimal slack, and although the patient's weight decreased slightly, only a small increase in slack was noted, still consistent with minimal slack overall.During anchor release, the lead was displaced laterally.Wire check confirmed a lateral trajectory relative to the lead.When the delivery system (ds) crossed, it came in septal to the lead.In the beginning, echo noted that this positioning did not place significant pressure on the pacemaker lead.As per medical opinion, the perceived root cause of the event would be the valve pushing the pacer too lateral.
Additional Manufacturer Narrative
The complaint for system interaction with previously implanted devices was confirmed with objective evidence via imaging evaluation.The device history record review was completed, and this device passed all manufacturing and sterilization inspections.No nonconformances related to the complaint event were identified.Available information suggests that a combination of wire placement and a pre-existing rv lead with minimal slack caused the lead to be displaced during evoque deployment.Review of the procedural tee confirmed that the evoque valve interacted with the rv lead during deployment (during ds crossing and atrial expansion), and that the rv lead appears more taut post evoque deployment.Additionally, the baseline imaging shows the rv lead is in a more central position than the septal position observed on screening.Since the delivery system crossed septal to the lead, during anchor expansion, the lead was displaced laterally.Since no manufacturing non-conformances were found and no labeling, training, or ifu deficiencies were identified, no preventative or corrective actions were required.

• Brand Name: EVOQUE DELIVERY 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: 24434958
• Report Number: 2015691-2026-11374
• Device Sequence Number: 10244323
• Product Code: NPW
• UDI-Device Identifier: 00690103217520
• UDI-Public: (01)00690103217520(17)260319(11)250319
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P230013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 03/18/2026

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 Expiration Date: 03/19/2026
• Device Model Number: 9850TDSUS
• Device Lot Number: 66360558
• 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: 01/19/2026
• Supplement Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 02/24/2026
• Supplement Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/19/2025
• 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