MAUDE Adverse Event Report: JENAVALVE TECHNOLOGY, INC. JENAVALVE TECHNOLOGY, INC.; Aortic Valve, Prosthesis, Percutaneously Delivered

Model Number	TRILOGY-THV-L
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Heart Problem (4454)
Date of Event	08/16/2026
Type of Reportable Event	Serious Injury

• 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 arana ; 4 cromwell; irvine, CA 92618 ; +1(949)767-2110
• MDR Report Key: 50831308
• Report Number: 3012148004-2026-70015
• Device Sequence Number: 18707753
• Product Code: NPT
• UDI-Device Identifier: 00850000898226
• UDI-Public: 00850000898226
• 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
• Device Implanted Year: 2026
• 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): 09/18/2026

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 Model Number: TRILOGY-THV-L
• Device Catalogue Number: TRILOGY-THV-L
• 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: 08/20/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/07/2026
• 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