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

Model Number 9610TF29

Device Problems Burst Container or Vessel (1074); Fluid/Blood Leak (1250); Inflation Problem (1310); Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/19/2023

Event Type  Injury  

Event Description

As reported from germany by our edwards lifesciences affiliate, during an aortic transcatheter heart valve replacement procedure via transfemoral approach, the 29mm sapien 3 valve and 29mm commander delivery system were advanced through the esheath into the descending aorta with strong resistance.There were difficulties aligning the valve, and the valve was not fully aligned on the delivery system balloon.It was decided to deploy the valve.After incomplete and partial deployment of the valve, the pusher of the delivery system was moved back into place and complete valve alignment was achieved.During the second inflation of the delivery system balloon, the balloon burst, and the valve was not completely deployed.The valve was pulled back into the descending aorta, and with two balloons the diameter of the partially expanded valve was minimized.The valve was then pulled back in to the infrarenal segment of the descending aorta without damaging the aorta.The delivery system was cut and withdrawn, leaving residual balloon material attached to the valve.The valve was expanded in the infrarenal aorta, and an aortic covered stent was placed, covering the complete infrarenal aorta and trapping the residual delivery system material.The patient was extubated the next day and transferred to the normal ward the day after the procedure.

Manufacturer Narrative

Investigation is ongoing.H3 other text : device was unavailable for evaluation.

Manufacturer Narrative

A supplemental mdr is being submitted for correction and additional information based on the device evaluation.The following sections of this report have been updated: additional code added to h.6 component code, additional codes added to h6 type of investigation, corrected h6 investigation findings, corrected h6 investigation conclusions, additional information added to h10.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.Imagery was not provided for review.A review of the lot history revealed no other similar returned complaints for the trend categories.A device history record (dhr) review was performed and did not reveal any manufacturing nonconformance that would have contributed to this complaint event.The instructions for use/training manuals were reviewed for guidance/instruction involving the commander delivery system usage.Based on the review of the ifu/training manuals, no deficiencies were identified.A review of the risk management documentation was performed, and 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 events were unable to be confirmed due to unavailability of the returned device and/or applicable imagery.Per report, the valve was not fully aligned on the balloon, however, it was decided to deploy it.Per the training manual, before deployment, ensure that the "thv is exactly between the valve alignment markers".Despite the valve not being aligned between the markers, the user decided to deploy the valve.As such, available information suggests that use error (failure to follow instructions) may have contributed to this event.A delivery system balloon leak was reported.During manufacturing balloons are 100% visually inspected at several different steps and devices are 100% leak tested.Therefore, it is unlikely that the delivery system left the manufacturing site with balloon damage.Additionally, there was no note of abnormalities or leakage on the delivery system during device preparation and de-airing, suggesting that there was no issue with the device when removed from packaging.A delivery system balloon leak may result from damage to the balloon material sustained through a combination of patient and/or procedural factors.The structural integrity of the balloon may be compromised via improper device preparation (crimping) or improper valve alignment techniques (excessive manipulation within tortuous anatomy).It may also be possible for the balloon to become damaged during delivery system advancement through sheath/vasculature via unfavored interactions between the balloon and the crimped thv (typically promoted by calcified, tortuous, and/or vessel-restricted anatomy via non-coaxial advancement angles).In this case, it is possible that while re-aligning the valve, a frame strut interacted with the balloon, or while re-crossing the native valve calcification damaged the balloon.However, due to insufficient information, a definite root cause is unable to be determined.Difficulty withdrawing the valve and residual balloon material separating from the device were reported.It is likely that due to the partial deployment of the valve, the thv had a larger profile than normal during withdrawal attempt, requiring additional intervention to reduce the balloon profile and facilitate withdrawal of the delivery system with crimped thv into the infrarenal aorta.Additionally, due to high degrees of calcification in patient anatomy (porcelain aorta), the thv was unable to be withdrawn further than the infrarenal aorta.This led to the user cutting the delivery system for removal, separating the nose tip, inflation balloon, and thv within the patient.Further intervention was required for deployment in non-target location of the separated thv, along with further anchoring of the thv and balloon remnants via deployment of a covered stent.Available information suggests that patient (calcification) and/or procedural factors (withdrawal of partially deployed thv, excessive manipulation) contributed to the withdrawal difficulty, while procedural factors (difficulty withdrawing delivery system with crimped thv) may have contributed to the component separation.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.No ifu/labeling/training manual inadequacies were identified.Therefore, no corrective or preventative action nor product risk assessment is required at this time.

Manufacturer Narrative

A supplemental mdr is being submitted for correction and additional information based on communication from the edwards lifesciences sales representative.It was clarified that the valve was not fully aligned on the delivery system balloon, but it was decided to deploy the valve.The valve expanded asymmetrically and moved aortic.The balloon was deflated, and the valve was re-aligned on the balloon and placed again the aortic annulus.When attempting to inflate the balloon again, the balloon did not inflate anymore due to a leak.As the valve was partially deployed, it could not be pulled back sufficiently to remove it surgically, and with two balloons the diameter of the partially expanded valve was minimized.The following sections of this report have been updated: h6 device code "1074 - burst container or vessel" changed to "1250 - fluid/blood leak".Investigation is ongoing.

Manufacturer Narrative

A supplemental mdr is being submitted upon administrative review.The following sections have been updated: additional code added to h6 investigation findings, additional code added to h6 investigation conclusions.

• Brand Name: COMMANDER DELIVERY SYSTEM
• 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: 18498043
• MDR Text Key: 332725868
• Report Number: 2015691-2024-00303
• Device Sequence Number: 1
• Product Code: NPT
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9610TF29
• Device Lot Number: 65218034
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2023
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male