MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS COMMANDER DELIVERY SYSTEM, 26MM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9610TF23

Device Problems Failure to Align (2522); Difficult or Delayed Activation (2577); Malposition of Device (2616)

Patient Problems Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692)

Event Date 01/07/2020

Event Type  Injury  

Manufacturer Narrative

Investigation is ongoing.

Event Description

As reported by our (b)(6) affiliate, during a transfemoral procedure of a 26mm sapien 3 in the aortic position, gross valve alignment was performed with no issues.While turning the valve alignment wheel to position the valve between the two markers, a ¿popping sound¿ was heard.Fluoroscopy showed the valve was grossly misaligned and a decision was made to proceed to use the pusher to try to align it back into position; however, the valve traveled further distal on the balloon.It was believed that the valve would be deployed too ventricular if an attempt was made to implant the valve at the level of the aortic valve and a decision was made to deploy it in the descending aorta.Another valve and delivery system were prepped, and the valve was successfully implanted into the native aortic valve.The patient was stable and discharged.The delivery system was discarded.

Manufacturer Narrative

Correction: model and lot number and expiration date (d4) and device manufacture date (h4).

Manufacturer Narrative

A supplemental mdr is being submitted for correction of the lot number, patient information and date of event.The incorrect lot number was inadvertently provided for a 26mm delivery system; however, the delivery system used in this case was 23mm.The following sections of this report have been corrected: age at the time of event (a2), patient sex (a3), date of event (b3), lot number and expiration date (d4) and device manufacture date (h4).

Manufacturer Narrative

Additional information was provided.The following sections of this report have been updated: describe event or problem (b5) and if implanted, give date (d6).The commander delivery system was returned to edwards for evaluation.The device was visually inspected, and no visual abnormalities were observed.Functional testing was performed on the fine adjust and there were no abnormalities observed.Dimensional testing was not performed due to the nature of the complaint.During manufacturing of the commander delivery system, the devices and its components are tested and inspected multiple times.Per procedure, the balloons are 100% visually and dimensionally inspected for defects.During fine adjust assembly the components and the handle are inspected.During the balloon pleat, fold and forming process the balloons are visually inspected.During final inspection, the entire device is inspected distal to proximal for defects as per procedure.Functional inspection is performed on the fine adjust functionality.In addition, per procedure, functional product verification (pv) testing is performed for visual damage, device insertion and find adjustment verification.During the pv testing, the device is fully flexed multiple times and verified to be functional after a total of several articulations since device assembly.These inspections support that it is unlikely that a manufacturing non-conformance contributed to the reported complaint.A device history record (dhr) review was performed and did not reveal any manufacturing non-conformances that could have contributed to the event.A lot history review was performed and revealed no other complaints relating to the complaint.A review of complaint history revealed that the occurrence rate did not exceed the january 2020 control limit for all the trend categories.The commander ifu, device preparation manual, and procedural training manual were reviewed for instructions and guidance on device preparation and usage.The procedural training manual provides guidance on valve alignment.Perform valve alignment in the straight section of the aorta, unlock, pull the balloon catheter straight back at the y-connector until part of the warning marker is visible and lock, do not bend or apply torque to the proximal end of the balloon catheter throughout the procedure, check delivery system before valve alignment.If kinked, do not use, slowly rotate the fine adjustment wheel towards you to center the thv exactly between the valve alignment markers with no gap or overlap, compression may be observed in the distal portion of the flex catheter during valve alignment and diving may be observed between the thv and flex catheter tip during valve alignment.To correct valve alignment, move to a different straight section of the aorta (diving only), if using the balloon catheter, push forward slightly and then continue pulling back until part of the warning marker is visible, and if using the fine adjustment wheel, reverse and then continue with fine adjustment until thv is centered exactly between the valve alignment markers.No ifu or training deficiencies have been identified.The complaints were not confirmed based on visual inspection of the returned device.Investigation of the device and complaint history revealed no indication that a manufacturing non-conformance contributed to the event.A review of manufacturing mitigations supports that the delivery system has proper inspections in place to detect issues related to the complaint events.A review of ifu/training materials revealed no deficiencies.As reported, ¿while turning the valve alignment wheel to position the valve between the two markers, a popping sound was heard and on fluoro, the distal portion of the thv was seen past the distal marker¿.It is possible that the fine adjust knob was overused, which may have caused the popping noise, causing the thv to be positioned distal to alignment markers leading to valve alignment difficulties, as once the thv is moved too distally it is not possible to be moved back proximally causing reported the unable to perform valve alignment.The thv training manuals instruct the operator on proper positioning and deployment of the valve, including all procedural and anatomical considerations.Physicians are extensively trained by edwards before they are qualified to use the sapien thv.Training includes patient screening, device preparation, approach, deployment, imaging, procedure-specific training manuals and proctored procedures.The correct alignment and positioning of the device at the point of deployment is emphasized as a key factor to the placement and fixation of the device.Operators are also instructed to use fluoroscopy as the primary method of visualization for positioning and deployment.In patients with high-risk anatomical features for aortic embolization (i.E.Minimal leaflet calcification, severe septal hypertrophy), bav may provide indication of potential balloon movement during valve deployment.There may be cases in which the valve is not able to be deployed at the intended location for various reasons.This may require deploying the valve at a non-target location, typically in the descending aorta.Although, generally well tolerated, the long-term effects are not completely understood.In this case, available information suggests that procedural factors (overturning the fine adjust wheel) may have contributed to the complaint events.However, a conclusive root cause is unable to be determined.The complaint history revealed that the occurrence rate did not exceed the january 2020 control limit for all the trend categories.No manufacturing non-conformances, labeling, training, or ifu deficiencies were identified; therefore, no corrective and preventative action nor pra is required at this time.

Event Description

The valve alignment was performed in a straight section of the aorta without tension.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: EDWARDS COMMANDER DELIVERY SYSTEM, 26MM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 9643945
• MDR Text Key: 176975773
• Report Number: 2015691-2020-10302
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/18/2021
• Device Model Number: 9610TF23
• Device Lot Number: 62351399
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/08/2020
• Initial Date FDA Received: 01/29/2020
• Supplement Dates Manufacturer Received: 02/12/2020; 04/07/2020; 04/28/2020; 07/23/2020
• Supplement Dates FDA Received: 02/12/2020; 04/08/2020; 04/30/2020; 02/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR