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

Model Number 9600LDS29A

Device Problem Device Slipped (1584)

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

Event Date 02/01/2023

Event Type  malfunction  

Event Description

Edwards received notification from a field clinical specialist of a transfemoral tmvr in a previously implanted in a non-edwards surgical valve.As reported, as the team began pacing in preparation for deploying the 1st valve across the mitral valve, the surgeon pushed the stiff wire forward to try and stand the 29 mm sapien 3 valve up.There was no difficulty inserting/advancing the delivery system through the sheath.There was no difficulty with valve alignment.When forward tension was placed on the wire the balloon catheter of the valve slid forward.During deployment the balloon fully expanded the outflow but did not in the inflow.The team worried about whether the valve was secure so they collapsed the balloon catheter and retracted it so that the distal dot was aligned with the outflow frame.Then the team post dilated while pacing.During the post dilation the first valve slipped ventricularly so that the big cells were now in the lvot and the inflow was not near the base of the 31m.The team then had to deploy a second valve across the surgical valve.

Manufacturer Narrative

The investigation is in progress.A supplemental report will be submitted.This is one of two manufacturer reports being submitted for this case.Device not available.

Manufacturer Narrative

The device was not returned for evaluation as it was remained implanted/discarded.Therefore, a no product return engineering evaluation was performed.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 complaint valve moves on balloon was unable to be confirmed as no applicable procedural imagery was provided for evaluation.Due to the unavailability of the device, engineering was unable to perform any visual, functional, or dimensional analysis; therefore, a manufacturing non-conformance was unable to be determined.Additionally, a review of the dhr and lot history did not provide any indication that a manufacturing non-conformance would have contributed to the complaint.A review of the ifu and training manuals revealed no deficiencies.As reported, ''as reported, as the team began pacing in preparation for deploying the 1st valve across the mv, the surgeon pushed the stiff wire forward to try and stand the 29 mm s3 valve up.There was no difficulty inserting/advancing the delivery system through the sheath.There was no difficulty with valve alignment.When forward tension was placed on the wire the balloon catheter of the valve slid forward''.In imagery provided by the field, it was observed that post-deployment of the thv, the balloon catheter was no coaxial with the thv.It is likely that the guidewire manipulation done to restore coaxial orientation of the balloon catheter resulted in built up tension on the balloon catheter.The procedural training manual advises to ''use the distal flex to position the thv coaxial'', ''slowly rotate the flex wheel away from you to help adjust the thv coaxial within the native valve'', and ''release delivery system tension prior to deployment by ensuring thv is coaxial within annulus on final position''.Manipulation of the guidewire in an attempt to bring the valve coaxial with the annulus/pre-existing bioprosthesis, instead of using flex as advised, likely caused additional tension build up in the system and the observed valve movement on balloon.However, without applicable procedural imagery, a definitive root cause is unable to be determined.Available information suggests that procedural factors (guidewire management) may have contributed to the complaint event.No device or labeling problem was identified during the evaluation.Therefore, no further escalation (capa/scar/pra) is required.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.This is one of two manufacturer reports being submitted for this case.Please reference related manufacturer report no: 2015691-2023-11023.

• Brand Name: COMMANDER DELIVERY SYSTEM
• Type of Device: PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA
• 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: 16428559
• MDR Text Key: 310193080
• Report Number: 2015691-2023-11022
• Device Sequence Number: 1
• Product Code: NPU
• UDI-Device Identifier: 00690103193961
• UDI-Public: (01)00690103193961(17)241113(10)64692202
• 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,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/10/2023

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: 9600LDS29A
• Device Catalogue Number: N/A
• Device Lot Number: 64692202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/01/2023
• Initial Date FDA Received: 02/23/2023
• Supplement Dates Manufacturer Received: 04/10/2023
• Supplement Dates FDA Received: 04/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2022
• 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 Sex: Male