MAUDE Adverse Event Report: EDWARDS LIFESCIENCES ALTERRA ADAPTIVE PRESTENT SYSTEM; PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED

Model Number	29AP4045A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As reported from a clinical study, approximately one (1) year and seven (7) days post transcatheter pulmonic valve replacement (tpvr) procedure with an alterra prestent and 29 mm sapien 3 valve, there was one (1) alterra prestent type i fracture.Medical records were received for evaluation.According to the medical records, approximately one (1) year and seven (7) days post tpvr procedure, an echocardiogram demonstrated no pulmonary valve stenosis and trivial to no pulmonary valve regurgitation.The patient also underwent a cardiac catheterization.Orthogonal fluoroscopic biplane views of the alterra prestent and sapien 3 valve demonstrated no frame fracture, no distortion, and no displacement when compared to a prior imaging study.Rotational cine imaging demonstrated stable position of both devices and evidence of one alterra prestent type i fracture was identified.There was no evidence of alterra prestent deformation, partial collapse, fragmentation, in-folding, or migration.
Additional Manufacturer Narrative
The investigation is ongoing.

• Brand Name: ALTERRA ADAPTIVE PRESTENT SYSTEM
• Common Device Name: PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 24809103
• Report Number: 2015691-2026-13934
• Device Sequence Number: 21318237
• Product Code: NPV
• UDI-Device Identifier: 00690103210866
• UDI-Public: (01)00690103210866(17)260216(11)240212
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P200015
• 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: Study,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2026

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: 02/16/2026
• Device Model Number: 29AP4045A
• 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: 03/16/2026
• Supplement Date Received by Manufacturer: 05/08/2026
• Initial Report FDA Received Date: 04/07/2026
• Supplement Report FDA Received Date: 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/12/2024
• 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
• Patient Sex: Male