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

Model Number 9610TF29

Device Problems Positioning Failure (1158); Failure to Align (2522); Malposition of Device (2616)

Patient Problems Calcium Deposits/Calcification (1758); Injury (2348)

Event Date 04/02/2020

Event Type  Injury  

Manufacturer Narrative

Edwards lifesciences continues to investigate the reported event and a supplemental report will be submitted in accordance with 21 cfr 803.56 when additional information becomes available.

Event Description

As reported by our affiliate in (b)(6), a transfemoral tavr procedure was performed for a 29mm sapien 3 valve in the aortic position.During the procedure, it was not possible to get the valve over the balloon while at the descending aorta.Therefore, the valve was placed in the descending aorta, and the delivery system was withdrawn.A new 29mm sapien 3 valve and delivery system were prepared and used.Valve alignment was performed in a straight section of the aorta and the valve was successfully implanted.It was perceived that the valve could not get over the balloon and that was the cause of the difficulty with valve alignment.No embolization or migration of the valve to aorta occurred.No withdrawal difficulties with the system were encountered.No injury to the patient was reported.Both valves remain implanted in the patient.Information regarding the native annular diameter was not provided.Moderate calcification and moderate tortuosity in the iliac artery and aorta were reported.

Manufacturer Narrative

This is one of two manufacturer reports being submitted for this case.Please reference related manufacturer report no: 2015691-2020-12526.

Manufacturer Narrative

The commander delivery system was not returned to edwards lifesciences for evaluation.Without the device, visual inspection, functional testing and dimensional analysis could not be performed.Review of procedural imagery provided by the site did not reveal relevant information related to the complaint investigation.Device history review (dhr) review was performed for the components most relevant to the reported event.The work orders did not reveal any manufacturing non-conformances that could have contributed to the reported event.Lot history review revealed no other similar complaints for the appropriate complaint code.Complaint history review revealed the occurrence rate did not exceed the april 2020 control limit for the associated trend category.Per the ifu and training manuals, in a straight section of the vasculature, initiate valve alignment by disengaging the balloon lock and pulling the balloon catheter straight back until part of the warning marker is visible.Do not pull past the warning marker.Warning: to prevent possible damage to the balloon shaft, ensure that the proximal end of the balloon shaft is not subjected to bending.Engage the balloon lock.Use the fine adjustment wheel to position the valve between the valve alignment markers.Caution: do not turn the fine adjustment wheel if the balloon lock is not engaged.Do not position the valve past the distal valve alignment marker.This will prevent proper valve deployment.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.Utilizing alternate fluoroscopic views may help with assessing curvature of the anatomy.If excessive tension is experienced during valve alignment, repositioning the delivery system to a different straight section of the aorta and relieving compression (or tension) in the system will be necessary.Before deployment, ensure that the valve is correctly positioned between the valve alignment markers and the flex catheter tip is over the triple marker.During the manufacturing process, the crimp balloon undergoes multiple 100% visual inspections during the final inspection process.During final inspection, the delivery system undergoes distal to proximal visual inspection, fine adjust functional testing and collet/shaft clearance.Additionally, product verification (pv) testing is performed on a sampling process.These inspections support that it is unlikely a manufacturing non-conformance contributed to the reported complaint.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 3 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 malposition (i.E.Minimal leaflet calcification, severe septal hypertrophy), bav may provide indication of potential balloon movement during valve deployment.In this case, the valve alignment complaint was not able to be confirmed.Under simulated conditions (simulated tortuous anatomy), a previously performed engineering study was able to recreate high valve alignment forces.It is possible that if the delivery system was improperly de-aired, residual fluid could remain in the balloon.Residual fluid in the balloon can alter balloon profile, this can contribute to increased forces during valve alignment.Per ifu/ device preparation manual, ¿ensure there is no residual fluid left in the balloon to avoid potential difficulty with valve alignment during the procedure.¿ additionally, it was reported that there was moderate tortuosity present in the vasculature.Under simulated conditions (simulated tortuous anatomy), a previously performed engineering study was able to recreate high valve alignment forces.Without further imagery, a definitive root cause was not able to be determined, however available information suggests in addition to procedural factors (residual fluid), patient factors (tortuous anatomy) may have contributed to the valve alignment difficulties which led to placement of the valve in the descending aorta.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.

Manufacturer Narrative

Corrected information: section b1 ¿ product problem.Additional information: section h10: narrative text.Based on imagery review information, section b1 has been changed to product problem.It was determined that the deployment of the initial sapien 3 valve in the descending aorta will be reported in a related complaint/mdr report.Procedural cine was provided for review.Images of the valve alignment were not provided for review.Results from the cine review indicated: · after crossing the annulus, the sapien 3 valve was not centered between the markers, approximately 1cm proximal of marker.· during deployment, the sapien 3 valve was pushed away as only the distal part was inflated by the balloon, resulting in the embolization of the valve into the aorta.· final position of the embolized sapien 3 valve in the descending aorta.· uneventful implantation of a second sapien 3 valve, with good result, no pvl, 80:20 a/v.Impression/recommendations: the sapien 3 valve was not centered between the markers before deployment (approx.1 cm off).If difficulty during valve alignment is encountered, the user should reposition the delivery system to a different straight section of the aorta and relieve compression or tension in the system.An alternate fluoroscopic view may help in assessing any curvature of the aortic anatomy.If valve alignment cannot be completed, removal and bail-out of the valve/ds is recommended in such a scenario per ifu/training instructions.The sapien 3 valve embolized during deployment and was implanted in the descending aorta.A second sapien 3 valve was implanted uneventfully with good result.This is one of two manufacturer reports being submitted for this case.

Manufacturer Narrative

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

• 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
• MDR Report Key: 9999159
• MDR Text Key: 192211171
• Report Number: 2015691-2020-11699
• 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: 04/02/2020

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: 12/04/2021
• Device Model Number: 9610TF29
• Device Lot Number: 62816516
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/02/2020
• Initial Date FDA Received: 04/25/2020
• Supplement Dates Manufacturer Received: 05/27/2020; 06/24/2020; 07/15/2020; 07/23/2020
• Supplement Dates FDA Received: 05/28/2020; 07/13/2020; 07/15/2020; 01/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR