MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS COMMANDER DELIVERY, 23MM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9610TF23U

Device Problem Failure to Align (2522)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/20/2023

Event Type  malfunction  

Event Description

As reported by edwards european affiliate, during implant of a 23mm sapien 3 ultra valve, the valve 'slipped up' a bit further than expected during valve alignment.During valve deployment with the commander delivery system, the valve expanded asymmetrically with the valve stent on the ventricular side taking longer time to open (expand the valve).The valve was implanted with good result and there was no patient injury.Of note, the balloon was noted to not have the 'small belly' on the distal shoulder.

Manufacturer Narrative

The investigation is ongoing.

Manufacturer Narrative

The commander delivery system was not returned to edwards lifesciences for evaluation.Without the device returned for evaluation, visual inspection, functional testing and dimensional analysis were unable to be completed.A device history record (drh) review was completed and did not reveal any manufacturing non-conformances that would have contributed to the reported event.A lot history review was performed and revealed no other similar reported events relating to the event.The event(s) reported is anticipated in the risk management documentation for transcatheter heart valve procedures.A previous investigation into this type of event is captured in an edwards lifesciences technical summary and applies to this complaint.Additional assessment of the failure mode is not required at this time.The complaint for navigate and position catheter to target location during valve alignment, and valve not between markers and deployed was unable to be confirmed as no imagery was provided.Review of 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 also revealed no deficiencies.The complaint for balloon incorrect shape was unable to be confirmed as no device or imagery was provided.However, as per previously investigated complaints showing the pumpkin formation on the inflation balloon was missing from the complaint units, a potential manufacturing defect was identified.As reported, 'during valve alignment, the valve then slipped up a bit further than expected.During valve implant, the valve was asymmetrically expanded since the valve stent on the ventricular side was opened much later'.In addition, as reported, 'the balloon, direction nose cone was missing the "small belly'.Per the training manual, 'do not position the thv past the distal valve alignment marker.This will prevent proper thv deployment.' it is likely that during fine adjustment of the valve onto the inflation balloon, fine adjust wheel was overly dialed causing the valve to be positioned too distal on the inflation balloon.Per training manual, the user is instructed to check if the valve is between the valve alignment markers prior to thv deployment.In this case, the user decided to deploy the valve even though it was positioned off the markers.During manufacturing process, the pumpkin on the distal end of inflation balloon is formed per procedure.A missing pumpkin indicates that the manufacturing process was done incorrectly and/or was incomplete.As a result, a product risk assessment has been initiated to further investigate and assess the risks associated with the reported issue.The complaint for 'balloon incorrect shape' was unable to be confirmed, but a potential manufacturing defect was identified.A product risk assessment was initiated for further investigation and risk assessment.No labeling, training, or ifu deficiencies were identified.Additionally, a personnel acknowledgement was performed as a response, as the capa decision tree determined no further escalation was required.In this case, available information suggests that procedural factors (over-rotation of fine adjust and not following instructions) may have contributed to the complaint event.No device problem or manufacturing non-conformance that would have contributed to the complaint event was identified during the evaluation.No labeling/ifu deficiencies were identified.Therefore, product risk assessment is required.H3 other text : device discarded.

• Brand Name: EDWARDS COMMANDER DELIVERY, 23MM
• Type of Device: AORTIC 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: 18213455
• MDR Text Key: 329912533
• Report Number: 2015691-2023-17741
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103208061
• UDI-Public: (01)00690103208061(17)250507(11)2305082165055797
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/09/2024

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
• Device Operator: Health Professional
• Device Model Number: 9610TF23U
• Device Lot Number: 65055797
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/03/2023
• Initial Date FDA Received: 11/27/2023
• Supplement Dates Manufacturer Received: 12/20/2023
• Supplement Dates FDA Received: 01/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/08/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1