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

Model Number 9600LDS23J

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/04/2022

Event Type  Injury  

Manufacturer Narrative

Investigation is ongoing.

Event Description

As reported by the edwards (b)(6) affiliate, a 23mm sapien 3 transcatheter heart valve was implanted during a transfemoral tavr procedure.While the operator evaluated for pvl and location of the implanted valve, the commander delivery system was backed out from the annulus.When post-dilation was about to be executed, safari guidewire came out.Radifocus guidewire was inserted to cross the annulus and then the safari guidewire was re-inserted.Commander delivery system was advanced again to execute the post-dilation.Right after the post-dilation, hemodynamics became instable.It was revealed that the safari guidewire was not across the sapien 3 valve, it was located outside the valve.The balloon was crashing the valve in the shape of a crescent moon.The percutaneous cardiopulmonary support (pcps) was implemented for stable hemodynamics and new 23mm sapien 3 valve was implanted.The patient became stable.The deformed first valve was moved to descending aorta and fixed with the stent graft.The procedure was closed.

Manufacturer Narrative

Added h.6 type of investigation and investigation findings.Corrected h.6 investigation conclusions.The device was not returned for evaluation.A device history review (dhr) was performed and did not reveal any manufacturing non-conformance issues that would have contributed to the complaint event.A lot history review was performed and revealed no other complaints relating to these events.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.The ifu, device preparation manual, and device procedural manual were reviewed.Factors that make it difficult to cross include: heavy calcification, wire bias into commissure, horizontal aorta, tortuous thoracic aorta, flex catheter kinked, and inadequate bav.If difficulty crossing is experienced, make sure the wire is correctly extended at the apex.Pull tension on the wire or reposition.Add some distal flex or remove some partial flex.Pull the system back and re-advance.Pull back flex catheter so it is off the balloon during deployment.Unlock the balloon lock.Slowly move back flex catheter (handle) while maintaining position of balloon catheter.Position flex tip in the middle of the triple marker.Lock the balloon lock.Placing flex tip on the middle of the triple marker will enable fine adjustment in either direction during thv positioning.Positioning flex tip on the triple marker prior to thv deployment will help maintain stability while ensuring unobstructed inflation during deployment.Partially unflexing may help when pulling back the flex catheter.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.Wire manipulation or slight rotation of the delivery system may help.Unlock the balloon lock.Position thv with bottom of center marker at base of cusps.The inflow of the sapien 3 valve will be further in the ventricle when positioned prior to thv deployment.Use the center marker to help aid in thv positioning, but not as a reference during thv deployment (center marker on delivery system not thv).A coplanar view is critical for correctly positioning and deploying the thv.To reference the center marker properly, ensure crimped thv is exactly between the valve alignment markers.Review positioning and thv heights with the echocardiographer prior to the case.For optimal results place the entire center marker within the initial center marker zone.Anatomy (stj, calcification, coronaries, etc.), % area sizing, thv size and foreshortening/inflation volume should also be considered when positioning thv.Use the fine adjustment wheel to control fine positioning of the thv.Ensure the flex tip is pulled back to the middle of the triple marker.Ensure the balloon lock is locked.Turn the fine adjustment wheel to finely control the thv position in either direction.Release stored tension prior to thv deployment.Thv may lock into the calcium when positioning creating stored tension in the delivery system.Release delivery system tension prior to deployment by ensuring thv is coaxial within annulus on final position.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.Since no product non-conformance was confirmed, a product risk assessment escalation is not required.Since no edwards defects were identified, no corrective/preventative actions are required.The cross difficulty and interaction with the pre-existing implantable device were unable to be confirmed as the complaint device and /or applicable imagery were not returned.Due to 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.A review of 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, ''when the post-dilation was about to be executed, safari guidewire came out.Radifocus guidewire was inserted to cross the annulus and then the safari guidewire was re-inserted'' and ''it was revealed that the safari guidewire was not crossed the sapien 3 valve and it was located outside the valve.Because of this, the balloon was crashing the valve in shape of crescent moon.'' when guidewire positioning was lost, it is likely the delivery system was crossed incorrectly due to poor visualization of guidewire placement.As a consequence of incorrect guidewire placement, the balloon did not expand within the valve but adjacent to it.Thus, leading to the reported negative interaction with pre-existing implantable device.Available information suggests procedural factors (guidewire positioning) contributed to the reported event.

• 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: 13625687
• MDR Text Key: 286506887
• Report Number: 2015691-2022-04198
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103194869
• UDI-Public: (01)00690103194869(17)230720(10)63901235
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/20/2023
• Device Model Number: 9600LDS23J
• Device Lot Number: 63901235
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/05/2022
• Date Device Manufactured: 07/21/2021
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 89 YR