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

Model Number	9850TDSUS
Medical Device Problem Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Edwards received notification of a transcatheter tricuspid valve replacement (ttvr) procedure involving the evoque system.Significant difficulty was encountered when retracting the outer capsule.Unintentional anchoring occurred at 45 degrees following back driving.Retraction of the outer capsule remained challenging throughout the procedure.The capsule was eventually retracted by adding 2.75 of depth; however, depth could not be removed once the capsule retracted past the locking ring.Any attempt to reduce depth resulted in further advancement of the outer capsule beyond the locking ring.After adjusting depth from 2.75 to 2, an audible click was noted, after which both the depth and white knobs became nonresponsive.Due to too ventricular positioning with the 56 mm valve, secondary was used to atrialize the valve.Secondary was brought to maximum, counter clocked, then followed by maximizing primary and applying a wire push.The blue knob worked properly.Leaflet capture was confirmed.No leaflet pinning observed at any point in the procedure.The anchors were at the hinge points of the annulus prior to final valve release.Valve expanded evenly and as expected during ventricular and atrial expansion stages.The valve looked stable with no pvl or central tr.Post deployment, the depth and outer capsule were unable to be removed during attempts to resheath.The blue knob was advanced to close the system.Upon removal from the body, testing confirmed that the white knob and depth adjustment were nonfunctional.The patient was reported to be in stable condition.However, upon review of post operative day (pod) 1echo, it appeared the device had embolized.The valve appears to be 90 degrees to the annulus.The patient subsequently had surgery to explant the valve and implant a surgical triscupid valve on pod 2.The patient was discharged home shortly thereafter and is doing well since.The perceived root cause of the event was reported to be the patient's venous tortuosity.Per the internal imaging evaluation, the reported difficulty retracting the outer capsule was unable to be confirmed.However, depth was noted to be between 2-3cm during ventricular and atrial expansion.Per internal review, the noted depth being sub-optimal is likely a contributing factor to the malposition of the device.
Additional Manufacturer Narrative
The manufacturer's investigation is ongoing and a follow-up report will be submitted when the investigation is complete.This is one of two manufacturer reports being submitted for the same event.Reference related manufacturer report (b)(4).

• 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: 24503007
• Report Number: 2015691-2026-11714
• Device Sequence Number: 10510175
• Product Code: NPW
• UDI-Device Identifier: 00690103217520
• UDI-Public: (01)00690103217520(17)260528(11)250528
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 05/05/2026

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/28/2026
• Device Model Number: 9850TDSUS
• Device Lot Number: 66691549
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2026
• 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: 02/19/2026
• Supplement Date Received by Manufacturer: 05/04/2026
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/28/2025
• 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 Age: 67 YR
• Patient Sex: Male