MAUDE Adverse Event Report: EDWARDS LIFESCIENCES COMMANDER DS WITH SAPIEN 3; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9750CM26A

Device Problem Inflation Problem (1310)

Patient Problem Insufficient Information (4580)

Event Date 04/26/2023

Event Type  Injury  

Event Description

As reported by a field clinical specialist (fcs), during deployment of a 26mm s3ur into a non-edwards surgical mitral valve, the valve balloon of the commander delivery system "appeared to "watermelon" seed into the left ventricle.Initial placement of the s3 looked to be on target." as per follow-up with the fcs, the first s3 was implanted.There was a 2nd valve attempted to be implanted transcatheter; however, the team was unable to advance and deployed.The attempt was aborted as the difficulty crossing and risk was outweighing the reward.The system was then removed and patient was converted to open procedure.The 1st s3 valve was then explanted.The 1st s3 was precariously still inside the surgical valve, but barely as it was way too high, but not loose in ventricle.The patient is stable, but was still in the hospital 1 week post-op.After reaching out to the fcs, it was confirmed that the reason for malposition of the 26mm s3ur was not caused by an edwards device malfunction or deficiencies but was likely caused either by stored tension in the commander delivery system, or by the commander delivery system valve balloon as it expanded, interacting with the pre-existing non-edwards surgical that was implanted in the mitral position, or a combination of both.During the navigation and alignment of the valve on the commander delivery system, tension can be created.This tension should be released prior to the delivery system and valve cross the aortic annulus.However, this appears not to have been the case and it resulted in the valve being malpositioned too ventricularly.The patient was taken to surgery, and the 26mm s3ur tmvr was explanted, and a surgical valve was implanted.The fcs clarified the "crossing difficulty" and stated that there was initially difficulty crossing the mosaic valve with the wire.The fcs was referring to crossing with the 2nd commander and valve.The 2nd system would not cross.Issues getting coaxial appeared to be a factor.

Manufacturer Narrative

Investigation is ongoing.This is one of three reports being submitted for this case.H3 other text : not returned.

Manufacturer Narrative

A supplemental mdr is being submitted due to engineering evaluation findings.The device was not returned to edwards lifesciences for evaluation.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 this event is not required at this time.The complaint for "valve deployment - inflation difficulty and/or incomplete inflation-partial or slow" was unable to be confirmed as no applicable imagery was returned for evaluation.The reported event does not allege a malfunction that could be related to an edwards manufacturing deficiency.A review of the ifu and training manuals revealed no deficiencies.As reported, "during deployment of a 26mm s3ur into a non-edwards surgical mitral valve, the valve balloon of the commander delivery system "appeared to "watermelon" seed into the left ventricle" and "after reaching out to the fcs, it was confirmed that the reason for malposition of the 26mm s3ur was not caused by an edwards device malfunction or deficiencies but was likely caused either by stored tension in the commander delivery system, or by the commander delivery system valve balloon as it expanded, interacting with the pre-existing non-edwards surgical that was implanted in the mitral position, or a combination of both." the following factors are known to contribute to "watermelon seeding" with respect to balloon inflation: thv misaligned on inflation balloon (not between valve alignment markers), rapid balloon inflation, anatomical feature (e.G.Balloon constrained by landing zone characteristics).Additionally received information clarified that that the operator had "some challenges getting coaxial with the delivery system." therefore, it is possible that some torquing (tension) was introduced while navigating the ds through mitral anatomy.The resulting torque could inhibit coaxial thv positioning prior to deployment and/or could cause the balloon to become untwisted during deployment, leading to abnormal inflation.It is also possible that the non-coaxial thv alignment caused the inflation balloon to interact with the pre-existing valve, leading to incomplete or asymmetric inflation.As such, available information suggests that procedural factors (tension build-up, non-coaxial thv alignment) and/or patient factors (pre-existing surgical valve) may have contributed to the reported event.However, a definitive root cause was unable to be determined at this time.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: COMMANDER DS WITH SAPIEN 3
• 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: 16981294
• MDR Text Key: 315737265
• Report Number: 2015691-2023-13158
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103207835
• UDI-Public: (01)00690103207835(17)250131(10)64862672
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9750CM26A
• Device Catalogue Number: 9750CM26A
• Device Lot Number: 64862672
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2023
• 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 Sex: Male