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

Model Number 9750CM23A

Device Problem Inflation Problem (1310)

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

Event Type  malfunction  

Manufacturer Narrative

Investigation is ongoing.H3 other text : device not received for evaluation.

Event Description

As reported via social media, ''we had an unusual expansion of the 23mm (+2cc) edwards sapien s3u (not resilia) today.Final result was fine but any thoughts on why this may have happened? there was no sub-aortic membrane.'' review of the images posted appears to show the valve was aligned correctly between the markers during inflation of the delivery system, the valve expanded within the appropriate time frame, and the balloon inflated asymmetrically.

Manufacturer Narrative

Corrected h.6 type of investigation, investigation findings, and investigation conclusions.The delivery system 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.During manufacturing of the commander delivery system, the delivery system and components are inspected several times throughout the manufacturing process.In addition, product verification testing was performed on a sampling basis and all testing met specifications.These inspections performed during manufacturing process and testing performed during product verification support that it is unlikely that a manufacturing non-conformance contributed to the reported events.The implanting physician posted a video on social media of the event.It was observed that upon inflation, the valve deployed asymmetrically.The valve eventually was able to fully deploy.The ifu, device preparation training manual, and device procedural training manual were reviewed.The user is instructed to 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.During valve deployment, ensure the thv is exactly between the valve alignment markers, flex tip is on the triple marker, and the balloon lock is locked.Perform thv deployment by first unlocking the inflation device.Initiate rapid pacing ensuring 1:1 capture, sbp <= 50 mmhg, and pulse pressure <10 mmhg.Confirm placement of center marker within optimal initial center marker zone.Begin initial deployment with a slow controlled inflation.Fully inflate and hold for 3 seconds to ensure complete deployment.Completely deflate the balloon and stop pacing and withdraw the balloon from the native valve.Verify flex tip is on triple marker to ensure full inflation of balloon during deployment and ensure stability of delivery system during thv deployment.Slow inflation during initial deployment may help with stability of the delivery system and thv during deployment.If considered, reposition only at the very early stage of deployment.Do not exceed 20 seconds for inflation and deflation of the delivery system.Always maintain control of the plunger of inflation device when releasing it.Never lock the inflation device during bav or thv deployment.A slow controlled inflation during initial deployment may help with stability of the delivery system and thv.No ifu/training deficiencies were identified.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.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 delivery system inflation difficulty and/or incomplete inflation was confirmed by the provided imagery.As the device was not returned, engineering was unable to perform any visual inspection, functional testing, or dimensional analysis.In addition, a review of the dhr and lot history was unable to be performed as the device lot information was not provided, therefore, the presence of a manufacturing non-conformance was unable to be determined.However, a review of manufacturing mitigation and ifu/training materials did not reveal any deficiencies.As reported, ''we had an unusual expansion of the 23mm (+2cc) edwards sapien s3u.'' the provided imagery illustrated the valve initially deployed asymmetrically but was eventually able to fully deploy.While there was no evidence indicates that a manufacturing non-conformance contributed to the complaint, investigation shows that the reported event may be related to device interactions resulting from a potential sheath distal tip torn.To further investigate and assess the potential risk associated with the issue, a product risk assessment has been initiated.A product risk assessment has been initiated to investigate the constrained inflation and its associated risks and a capa determination has been initiated.

• 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: 18472117
• MDR Text Key: 332385723
• Report Number: 2015691-2024-00171
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9750CM23A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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