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

Model Number	29AP4045A
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Great Vessel Perforation (2152); Pericardial Effusion (3271)
Date of Event	08/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is ongoing.
Event or Problem Description
During a transcatheter pulmonary valve replacement (tpvr) procedure involving a 29mm sapien 3 valve, the field clinical specialist (fcs) reported that the patient, who presented with congenital pulmonary stenosis and a native main pulmonary artery (mpa), underwent alterra deployment with wire positioning achieved via the left pulmonary artery (lpa).The alterra stent was deployed with a slight angle, though it was not deemed problematic.The pds tracked successfully, and the valve was deployed.However, post-deployment angiography revealed significant tilting of the distal anterior and lateral apices against the mpa.A pericardial effusion began to develop and, although initially drained, it recurred persistently.The cardiovascular operating room (cvor) team was consulted, and a multidisciplinary decision was made to proceed with surgical explantation of the device.At last report, the patient was stable and doing well.
Additional Manufacturer Narrative
Correction to h6; component code, clinical code, type of investigation, investigation findings, investigation conclusion.The event reported is anticipated in the risk management documentation for transcatheter heart valve procedures.Additional assessment of the failure mode is not required at this time.Due to the unavailability of the complaint device, engineering was unable to perform any visual inspection, functional testing, or dimensional analysis.Per the technical summary, the ifu, current risk mitigations include design and manufacturing controls, and training.The reported event was confirmed based on the evaluation of the provided imagery and event description.A review of the dhr and lot history did not provide any indication that a manufacturing non-conformance would have contributed to the complaint event.Additionally, a review of ifu/training materials revealed no deficiencies.Per event description, "the alterra stent was deployed with a slight angle, though it was not deemed problematic.The pds was tracked successfully, and the valve was deployed.However, post-deployment angiography revealed significant tilting of the distal anterior and lateral apices against the mpa.A pericardial effusion began to develop and, although initially drained, it recurred persistently.The cardiovascular operating room (cvor) team was consulted, and a multidisciplinary decision was made to proceed with surgical explantation of the device." per the training manual, the alterra apices are designed to engage with anatomy to assist in initial placement and acute stability.Apex engagement with the anatomy is critical for prestent fixation and to avoid migration.However, in this case of device penetration occurred and led to a pericardial effusion and required additional surgical interventions such as including replacement of an antegrade rsfa sheath for perfusion.During the imaging review, the alterra was deployed in a significantly dilated rvot with an intact annulus, using a guidewire placed in the lpa.The wire placement introduced a leftward bias, causing the device to interact with anterior-superior wall.The absence of lateral imaging limited spatial assessment, masking critical misalignment.The excessive forward tension and sudden release of mechanical energy likely caused the perforation.Additionally, the inherent design of the present featuring outward-flared, pointed apices with chronic outward force intended for secure anchoring may have further contributed to the event once misalignment occurred.In addition, the alterra prestent is designed with outward flared/pointed apices and sufficient outward chronic force to allow proper retention of prestent to various and challenging patient anatomies.Available information suggests that procedural factors (combination of wire bias, lack of multi-angle imaging, procedural techniques), in addition to the prestent's design, may have contributed to the reported event.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.An investigation has been opened to determine the root cause and implement any necessary corrective actions.

• 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: 22907728
• Report Number: 2015691-2025-07052
• Device Sequence Number: 15725635
• Product Code: NPV
• UDI-Device Identifier: 00690103210866
• UDI-Public: (01)00690103210866(17)270426(11)250421
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P200015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 29AP4045A
• Device Lot Number: 66490481
• 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: 08/09/2025
• Supplement Date Received by Manufacturer: 10/06/2025
• Initial Report FDA Received Date: 08/27/2025
• Supplement Report FDA Received Date: 10/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/21/2025
• 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: 76 YR
• Patient Sex: Female
• Patient Weight: 57 KG