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

Model Number 9600LDS29A

Device Problem Device Slipped (1584)

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

Event Date 05/27/2022

Event Type  malfunction  

Manufacturer Narrative

Valve discarded.Investigation is ongoing.This is one of two manufacturer reports being submitted for this case.Please reference related manufacturer report no: 2015691- 2022- 06276.Device discarded.

Event Description

As reported by field clinical specialist, this was a placement of a 29mm sapien 3 valve placement in the mitral position in mac case.Lampoon was performed.When the physicians started to inflate it was noted that the valve was not centered to the balloon.Upon inflation only the distal portion of the balloon began to inflate, the valve began to move further proximal and the valve tilted.The physician was instructed to slow down the rate of inflation to allow for the proximal portion of the balloon to fill.Once the proximal portion of the balloon filled deployment was completed.Tee demonstrated pvl.During the first inflation there was already 4cc extra in the inflation device.The physicians decided to post dilate to try and seal the pvl.They added an additional 4cc to the inflation device.Post dilatation was completed with no change in the pvl.The procedure completed and the patient was to be monitored overnight.The following day the patient developed hemolysis and the physicians decided to bring the patient to surgery and remove the thv and place another sapien 3 valve.Per follow up information, the devices were discarded.When asked if there was any discussion regarding the cause of the valve not centered on the balloon prior to valve deployment, the physician suggested that valve alignment in the sheath may have contributed but they had no difficulty doing so.There were no issues with valve alignment, the valve was crimped properly, and the valve moved on the balloon during the procedure.No 3mensio is available.At last reported the patient was having pulmonary issues but stable.

Manufacturer Narrative

Update to b4, g3, g6, h2, h6 and h10 for no product returned evaluation.As no device was returned, no visual inspection, functional testing or dimensional testing could be performed.The work orders related to the manufacturing of the devices and components that could potentially contribute to the complaint did not reveal any manufacturing nonconformance issues that would have contributed to the complaint event.A lot history review of the related work order was performed and revealed no other complaints relating to the complaint codes below.As no device was returned and there is no evidence to support a manufacturing/design defect potentially contributed to the complaint, a manufacturing mitigation review is not required.Video was provided by the field.Incomplete expansion of the valve was seen, and the valve was not centered on the inflation balloon.The distal portion of the balloon seemed to have expanded prior to the proximal portion of the balloon.It should be noted that off-label implant of a 29mm sapien 3 valve into the native calcified mitral valve for this case.The edwards 29mm sapien 3 valve with the commander delivery system is not indicated for implantation into a native mitral calcified valve with no pre-existing surgical ring or bioprothesis.The ifu and training manuals in this section were reviewed for relevant guidance for an s3 implant using a commander delivery system within recommended native valve annulus size.The commander with s3 and s3u ifu, commander with s3 device preparation manual, commander with s3 procedural manual and commander with s3 mitral valve-in-valve supplement manual were reviewed.There is a warning that 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.No ifu/training deficiencies were identified.A complaint history review on confirmed device complaints (returned and no product returned) from july 2021 - june 2022 for the commander delivery system (all models and sizes) was performed with the relevant codes.No additional confirmed complaints were identified that had had similar events within the specified time frame.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 valve not aligned between markers was confirmed based on provided imagery.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, ''during valve alignment they centered the valve to the balloon as usual without difficulty.As soon as they started to inflate is when it was noticed that it was no longer centered.'' additionally, it was reported ''the physician suggested that valve alignment in the sheath may have contributed but they had no difficulty doing so.'' the mitral supplementary manual advises valve alignment to be performed in a straight section of the inferior vena cava.As reported, valve alignment for this procedure was conducted within the sheath.Valve alignment in the sheath may introduce additional compressive forces onto the catheter and/or thv during valve alignment and induce tension on the system.This tension could have prevented the user from adequately aligning the valve onto the balloon resulting in improper valve alignment being performed, and subsequently the thv not being centered on the inflation balloon as reported.As such, available information suggests that procedural factors (valve alignment conducted in sheath) likely contributed to the event.However, due to lack of device or imagery, a definitive root cause is unable to be determined.Since no product non-conformances or ifu/training deficiencies were identified during evaluation, a product risk assessment escalation is not required.Since no manufacturing non-conformances or ifu deficiencies were identified, corrective action is not required.The ifu and training manuals have been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.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.No corrective or preventative actions are required.

• Brand Name: EDWARDS 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: 14748556
• MDR Text Key: 302057505
• Report Number: 2015691-2022-06277
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103193961
• UDI-Public: (01)00690103193961(17)231129(10)64121119
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/29/2023
• Device Model Number: 9600LDS29A
• Device Catalogue Number: N/A
• Device Lot Number: 64121119
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2021
• 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