MAUDE Adverse Event Report: Jenavalve Technology, Inc Jenavalve Technology, Inc; Aortic Valve, Prosthesis, Percutaneously Delivered

Model Number	TRILOGY-DC-L
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	07/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a transcatheter aortic valve (thv) procedure, a 27mm trilogy heart valve was successfully deployed.Following deployment, the physician encountered difficulty withdrawing the delivery catheter into the sheath during delivery system removal.Deformation at the sheath tip was observed after retrieval. this resulted in injury to the femoral artery, and vascular surgery was performed to repair femoral artery.The delivery catheter is not available for return.A full device history record review of the system was conducted, and all system components met acceptance criteria.Instructions for use indicate on 7.5.3 step include the following: "caution do not retract the delivery catheter if resistance is encountered at the introducer sheath tip ad this can damage the sleeve and/or introducer sheath and lead to vascular damage during the system withdrawal.Instead, reposition the introducer sheath to ensure proper alignment with the sleeve under fluoroscopy and slowly retract the sleeve into the introducer sheath"  .

• Brand Name: Jenavalve Technology, Inc
• Common Device Name: Aortic Valve, Prosthesis, Percutaneously Delivered
• Manufacturer (Section D): Jenavalve Technology, Inc; 4 cromwell; irvine CA 92618
• Manufacturer (Section G): Jenavalve Technology, inc; 4 cromwell; irvine CA 92618
• Manufacturer Contact: maria jose arana ; 4 cromwell; irvine, CA 92618 ; +1(949)767-2110
• MDR Report Key: 50184032
• Report Number: 3012148004-2026-70009
• Device Sequence Number: 18629690
• Product Code: NPT
• UDI-Device Identifier: 00850000898158
• UDI-Public: 00850000898158
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P250024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/07/2026

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 Model Number: TRILOGY-DC-L
• Device Catalogue Number: TRILOGY-DC-L
• Device Lot Number: DS-042226-007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2026
• Initial Report FDA Received Date: 08/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/24/2026
• 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: Unknown