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

Model Number 9600LDS26A

Device Problems Deflation Problem (1149); Inflation Problem (1310)

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

Event Date 03/03/2021

Event Type  malfunction  

Manufacturer Narrative

Edwards lifesciences continues to investigate the reported event and a supplemental report will be submitted in accordance with 21 cfr 803.56 when additional information becomes available.

Event Description

As reported, during a pulmonic valve replacement via the jugular approach, difficulties were encountered during the advancement of the 26mm sapien 3 valve and commander delivery system due to the patient anatomy.Following manipulation of the delivery system, the valve was positioned in the pulmonary artery.During valve deployment, the delivery system balloon would not inflate.The inflator/deflator was turned multiple times while the plunge was pushed.The balloon was finally able to be inflated and the valve was deployed.Following valve deployment, the inflator/deflator was not able to be deflated.The delivery system handle was turned and rotated counterclockwise multiple times.The balloon was able to be deflated enough to remove it from the valve.Deflation of the balloon continued until the delivery system was able to be pulled back into the sheath and removed from the patient.The patient was transferred in stable condition.On postoperative day (pod) 1, an increase in tricuspid regurgitation was reported.Per medical opinion, this may be due to the manipulation of the devices during the pulmonic procedure.No actions were reported.The valve remains implanted in the patient.

Manufacturer Narrative

The commander delivery system was not returned to edwards lifesciences for evaluation.Without the device, visual inspection, functional testing and dimensional analysis could not be performed.No relevant case imagery was provided for review.Device history review (dhr) was performed for the components most relevant to the reported event.The work orders did not reveal any manufacturing non-conformances that could have contributed to the reported event.Lot history review revealed no other similar complaints.During the delivery system manufacturing process, the inflation balloon undergoes multiple 100% visual and functional inspections.The crimp balloon features and flex catheter undergo multiple visual inspections.The commander delivery system undergoes 100% occlusion testing and the balloon catheter undergoes 100% leak testing.Additionally, product verification testing (pv) is performed on a sampling basis for each lot.All units tested passed product verification testing.These inspection during manufacturing support that it is unlikely that a manufacturing non-conformance contributed to the complaint event.The instructions for use (ifu), device preparation manual, and procedural training manual were reviewed for instructions/guidance on device preparation/usage.Do not mishandle the delivery system or use it if the packaging or any components are not sterile, have been opened or are damaged (e.G.Kinked or stretched), or the expiration date has elapsed.Visually inspect all components for damage.Ensure the edwards commander delivery system is fully unflexed and the balloon catheter is fully advanced in the flex catheter.To prevent possible damage to the balloon shaft, ensure that the proximal end of the balloon shaft is not subjected to bending.Warning: if valve alignment is not performed in a straight section, there may be difficulties performing this step which may lead to delivery system damage and inability to inflate the balloon.Utilizing alternate fluoroscopic views may help with assessing curvature of the anatomy.If excessive tension is experienced during valve alignment, repositioning the delivery system to a different straight section of the vena cava and relieving compression (or tension) in the system will be necessary.Verify the correct position of the valve with respect to the landing zone.Before deployment, ensure that the valve is correctly positioned between the valve alignment markers and the flex catheter tip is locked over the triple marker.Begin initial deployment with a controlled slow inflation.Fully inflate and hold for 3 seconds to ensure complete deployment.Completely deflate the balloon.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.In this case, the complaints were not able to be confirmed as the complaint device was not returned and no case imagery was provided for review.As the complaint device was not returned, engineering was unable to perform any visual, functional, or dimensional analysis.Therefore, no manufacturing non-conformances were able to be identified.A review of dhr, lot history, complaint history, and manufacturing mitigations supported that a manufacturing non-conformance likely did not contribute to the reported events.This case involved the use of expired product and of note, there is no established product performance characteristics beyond its expiration date.Per the events reported for this case, it appears that the factors contributing to the complaint were more patient and procedural.The complaint description states, 'as reported, during a pulmonic valve replacement via the jugular approach, difficulties were encountered during the advancement of the 26mm sapien 3 valve and delivery system due to the patient anatomy.Following manipulation of the delivery system, the valve was positioned in the pulmonary artery.' if the patient's anatomy has tortuosity or calcification present, this may contribute to tracking difficulties.Obstructive calcification and tortuosity may have prevented the advancement of delivery system.However, characteristics of jugular artery at location of resistance was unable to be determined as patient imagery was not provided for evaluation and the delivery system could not be assessed for signs of interaction with calcification due to no device return.As mentioned in the complaint description, the delivery system was manipulated to overcome tracking difficulties.If device was torqued and excessively rotated before deployment, it is possible the excessive rotations of the delivery system may have contributed to the inflation and deflation difficulties.Without the applicable procedural imagery or return of the complaint device, there is insufficient information to determine a root cause.Available information suggests that patient factors (vessel calcification, tortuous anatomy) may have contributed to the manipulation of the delivery system.Procedural factors (device manipulation) may have contributed to the complaint reported excessive inflation and deflation time.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.There were no ifu, labeling, or training manual inadequacies, and no manufacturing non-conformances were identified during this evaluation.Therefore, no corrective or preventative actions are required at this time.

Manufacturer Narrative

An administrative review of 3500a forms posted on the maude database showed this manufacturer report was submitted with the incorrect (common device name, product code, pma number, or other missed or incorrect information).For follow-up report 2, a correction to fields d2 and g4 was submitted in the supplemental report.

Manufacturer Narrative

An administrative review of 3500a forms posted on the maude database showed this manufacturer report was submitted with the incorrect (common device name, product code, pma number, or other missed or incorrect information).A correction to fields (list the corrected fields on the form) is being submitted in this supplemental report.

• Brand Name: EDWARDS COMMANDER DELIVERY SYSTEM
• Type of Device: 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: 11554411
• MDR Text Key: 249098781
• Report Number: 2015691-2021-02017
• Device Sequence Number: 1
• Product Code: NPV
• UDI-Device Identifier: 00690103193954
• UDI-Public: (01)00690103193954(17)190417(10)60863583
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P200015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/17/2019
• Device Model Number: 9600LDS26A
• Device Lot Number: 60863583
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2017
• 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
• Patient Age: 15 YR
• Patient Sex: Male