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

Model Number 9610TF26U

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/02/2022

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.This is one of two manufacturer reports being submitted for this case.Please reference related manufacturer report no: 2015691-2022-07416.

Event Description

As reported by our edwards affiliate in germany, during a transfemoral tavr procedure, a 26mm sapien 3 ultra valve was deployed in the aortic position.During valve deployment, difficulties were encountered during valve alignment and the physician reported 'some friction in the system'.The commander delivery system and valve moved aortic.The valve was able to be re-positioned in the descending aorta and deployed.A second 26mm sapien 3 ultra valve was deployed without issue.At the time of the report, the patient was in stable condition.Both valves remain implanted in the patient.It was speculated that the friction between devices may have contributed to the event.

Manufacturer Narrative

Corrected information: section h6 (type of investigation, investigation findings, and investigation conclusions).Additional information: section h10.The commander delivery system was returned to edwards for evaluation.Visual inspection revealed no damage, abnormalities or leakage on the balloon.During functional testing, the balloon shaft was able to be pulled to the warning marker.Slight resistance was noted when pulling from packaging position to default position, likely due to the balloon shaft kink interacting with the locking mechanism.The delivery system was able to pull from the default to warning marker with no noted resistance and was able to lock and utilize full fine adjustment with no abnormalities observed.Due to the nature of the complaint, no applicable dimensional testing was able to be performed.Review of the provided case imagery revealed the initial valve embolized and was deployed in the descending aorta.The second valve was deployed in the intended position.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.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 this adverse event is not required at this time.In this case, the complaints for valve alignment difficulty was confirmed, however resistance with flex shaft was not able to be confirmed as no applicable procedural imagery was provided for evaluation.No manufacturing non-conformances were identified during engineering evaluation.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, 'there were difficulties with the fine adjust of the valve alignment' as no patient or procedural information was provided a definite root cause is unable to be determined at this time.Also reported, 'friction of the delivery system, inner and or outer catheter' was experienced and operators felt 'some friction in the system' while inflation and during rapid pacing.Based on a review of past complaints the following may have contributed to the difficulties noted: altered balloon profile affected by device preparation steps, such as inflating the balloon past the recommended 20-30% as instructed in ifu materials or leaving residual fluid in the balloon after de-airing.Attempts to align valve over inflation balloon in these conditions can lead to the valve catching onto balloon material and contributing to the valve alignment difficulties reported.If valve alignment was performed in a tortuous (non-straight section) vasculature, it can cause the valve to become unseated (non-coaxial placement of valve in relation to the flex tip) and 'dive' into the flex tip.If the thv is unseated from the flex tip during alignment, it can result in higher-than-normal alignment forces creating high tension in the system which can consequentially lead to the reported valve alignment difficulties.If there is tortuosity present in the vasculature, it may be difficult to move the balloon shaft through bends in the anatomy.It is possible that navigating the delivery system through a tortuous anatomy can result in built-up tension in the system.If tension is not released, it is possible that the tension may have increased resistance between the shafts and resulted in the reported difficulties.Per the training manual, 'partially unflexing may help when pulling back the flex catheter.' in this case, although a definite root cause could not be determined, available information suggests in addition to procedural factors (tension build up), patient factors (tortuosity) may have contributed to the reported events.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 monthly, 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
• 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: 15284980
• MDR Text Key: 298507766
• Report Number: 2015691-2022-07488
• Device Sequence Number: 1
• Product Code: NPT
• 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: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 12/10/2023
• Device Model Number: 9610TF26U
• Device Lot Number: 64128457
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2021
• 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: 72 YR
• Patient Sex: Female