MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS COMMANDER DELIVERY; PULMONARY VALVE PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number	9600LDS29A
Medical Device Problem Codes	Difficult to Remove (1528); Device Slipped (1584)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by a field clinical specialist (fcs), during a tpvr procedure with a 29mm sapien 3 valve (s3), the patient was brought down to the cath lab for a tpvr.Initially the plan was to go rij and balloon size the annulus.After ballooning, the decision for a 29 s3 was made.After multiple tries utilizing the non-edwards sheath that was in the rij, the decision to abort and go rfa due to tortuosity.While trying to remove the 29 s3 and commander system, the commissures on the valve frame, we believe, did not allow for the valve to be pulled back into the non-edwards sheath and under fluoroscopy, the team visualized the valve being pushed off the balloon of the commander system.After stopping we were able to snare the valve for protection through the rfa and were able to pull the commander system, the 29 s3, and the sheath out of the rij.Valve never embolized in the pt.Body.Access site was dry and hematoma free.Once switching to the groin, a new 29mm s3 was prepped and deployed with no issues.Per the fcs the device was not damaged to the eye, but noticed the valve was slipping off the balloon during removal.
Additional Manufacturer Narrative
The investigation is ongoing.
Additional Manufacturer Narrative
A supplemental mdr is being submitted for additional information from a product investigation.The following sections of this report have been updated: b4, g3, g6, h2, and h6.The complaints for thv dislodged off balloon during withdrawal through non-edwards sheath was unable to be confirmed as no applicable imagery or device returned for evaluation.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.The device was not returned for evaluation.Due to the unavailability of the complaint device, engineering was unable to perform any visual inspection, functional testing, or dimensional analysis.A review of edwards lifesciences risk management documentation was performed for this case.Per review, no evidence of product non-conformances or labeling/ifu inadequacies were identified in the evaluation.As reported, '''after multiple tries utilizing the 26frx65cm gore dryseal that was in the rij, the decision to abort and go rfa due to tortuosity.While trying to remove the 29 s3 and commander system, the commissures on the valve frame, we believe, did not allow for the valve to be pulled back into the dryseal and under fluoroscopy, the team visualized the valve being pushed off the balloon of the commander system.After stopping we were able to snare the valve for protection through the rfa and were able to pull the commander system, the 29 s3, and the sheath out of the rij.'' in this case, it is possible that the tortuosity of the vasculature likely contributed to the withdrawal difficulty when attempting to pull the delivery system and valve back into the non-edwards sheath.Tortuosity can create a non-coaxial withdrawal angle between the delivery system and the sheath tip.This can cause the valve to interact with the sheath tip during removal, leading to withdrawal difficulties.Since the valve was not fully retrieved back into the sheath, the exposed valve strut could have interacted with the surrounding vasculature and dislodged off the balloon as they continued to remove the device.As such, available information suggests that patient factors (tortuosity) and/or procedural factors (non-coaxial withdrawal) may have contributed to the complaint events.Complaint histories for all reported events are reviewed against trending control limits monthly, and any excursions above the control limits are assessed and documented as part of this monthly review.As such, neither a product risk assessment, nor corrective or preventative actions are required at this time.

• Brand Name: EDWARDS COMMANDER DELIVERY
• 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: 22413514
• Report Number: 2015691-2025-05486
• Device Sequence Number: 18565055
• Product Code: NPV
• UDI-Device Identifier: 00690103193961
• UDI-Public: (01)00690103193961(17)261202(10)66184770
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P200015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2025

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: 9600LDS29A
• Device Lot Number: 66184770
• 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: 06/12/2025
• Supplement Date Received by Manufacturer: 08/01/2025
• Initial Report FDA Received Date: 07/07/2025
• Supplement Report FDA Received Date: 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/02/2024
• 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: Unknown