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

Model Number	29AP4045A
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is one of two manufacturer reports being submitted for this case.Investigation is ongoing.
Event or Problem Description
As reported by the edwards field clinical specialist, during a case in pulmonic position, an alterra device was placed in the pulmonary annulus without difficulty.As the physician was tracking the pulmonic delivery system (pds), the pds bumped into the first alterra as the physician was advancing it through and caused it to dislodge.The alterra migrated distal into the main pulmonary artery.The pds was removed and a second alterra was placed to secure a landing zone.The distal portion of the second alterra was placed in the proximal portion of the first alterra to secure the first alterra.The team then used a commander delivery system to place a new 29 mm sapien 3 valve in the alterra waist.The systems were removed, and the patient was transferred to recovery.
Additional Manufacturer Narrative
Updated section h6- type of investigation, findings, and conclusions.This is one of two manufacturer reports being submitted for this case.Please reference related manufacturer report no: 2015691-2025-05035.A review of edwards lifesciences risk management documentation was performed for this case.The reported event is an anticipated risk of the transcatheter heart valve procedure, additional assessment of the failure mode is not required at this time.The complaint for prestent migration was unable to be confirmed as no applicable imagery or device returned for evaluation.As the device was not returned, engineering was unable to perform any visual examination, functional testing, or dimensional analysis.Therefore, the presence of a manufacturing non-conformance was unable to be determined.However, review of the dhr and lot history did not provide any indication that a manufacturing non-conformance would have contributed to the complaint event.A review of ifu/training materials revealed no deficiencies.Furthermore, no abnormalities were reported during device unpacking or preparation.As reported, "during a case in pulmonic position, an alterra device was placed in the pulmonary annulus without difficulty.As the physician was tracking the pulmonic delivery system (pds), the pds bumped into the first alterra as the physician was advancing it through and caused it to dislodge.The alterra migrated distal into the main pulmonary artery." in this case, it is likely that the pds interacted with the prestent upon advancement to the landing zone.This contact likely made it difficult for the pds to advance forward, resulting in additional maneuvers to advance and may have forced the prestent out of position.As such, available information suggests that procedural factors (pds interaction with prestent, device manipulation) have contributed to the complaint 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.Since no edwards product defects or labeling deficiencies were identified, no corrective or preventative action is required.

• Brand Name: ALTERRA ADAPTIVE PRESTENT SYSTEM
• Common Device Name: PULMONARY VALVE PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 22294391
• Report Number: 2015691-2025-05034
• Device Sequence Number: 8271270
• Product Code: NPV
• UDI-Device Identifier: 00690103210866
• UDI-Public: (01)00690103210866(17)260727(11)240722
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2025

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 Expiration Date: 07/27/2026
• Device Model Number: 29AP4045A
• Device Catalogue Number: N/A
• Device Lot Number: 65906621
• 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: 05/29/2025
• Supplement Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 06/19/2025
• Supplement Report FDA Received Date: 07/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/22/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male