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

Model Number 9610TF26U

Device Problems Difficult or Delayed Positioning (1157); Material Fragmentation (1261); Difficult to Remove (1528); Material Split, Cut or Torn (4008)

Patient Problem Unspecified Vascular Problem (4441)

Event Date 07/27/2022

Event Type  Injury  

Manufacturer Narrative

The investigation is ongoing.A supplemental report will be completed upon completion.

Event Description

Edwards received notification from our affiliate in austria.As reported, this was a case of an implant of a 26mm sapien 3 ultra valve in the aortic position by left transfemoral approach.When trying to place the valve through the native valve some difficulties were noted and it was unsuccessfully attempted to slightly open the balloon to pass through the native valve.However, it was not possible to place the sapien 3 ultra through the native valve.A valvuloplasty (bav) was performed through the right femoral approach and the native valve was successfully dilatated.The sapien 3 ultra could be easily positioned and tracked, but upon deployment, the balloon did not inflate.There was difficulty pulling the valve back into the esheath to remove the whole system as a single unit due to the valve being slightly unfolded and not fitting into the esheath.Therefore, a surgical cutdown was performed to be able to remove the commander with the valve and esheath.After the surgical vessel repair a second kit was opened, and the valve was successfully implanted without any complications through the left femoral.The patient was stable throughout the procedure and was transferred to the icu.As per medical opinion, the event was caused by a highly calcified native valve and the bicuspid anatomy.

Manufacturer Narrative

The device was returned for evaluation and an engineering evaluation was performed.Visual inspection of the returned device was performed and the following was observed: flex shaft and guidewire lumen and valve were found cut.The balloon was torn.No missing balloon material.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 device history record (dhr) review did not reveal any manufacturing nonconformance issues that would have contributed to the event.A lot history review was performed and revealed no other complaints relating to this event.The complaints of inability to withdraw system with valve through sheath, balloon torn, and balloon separated were confirmed based on the condition of the returned devices.However, the complaint of inability to cross native annulus was unable to be confirmed due to lack of returned imagery.A manufacturing non-conformance was not confirmed during the evaluation.A review of the dhr, lot history, and complaint history did not provide any indication that a manufacturing non-conformance would have contributed to the complaints.A review of ifu/training materials revealed no deficiencies.For the complaint of inability to cross native annulus, as reported, ''when trying to place the valve through the native valve some difficulties were found, and it was unsuccessfully attempted to slightly open the balloon to pass through the native valve''.It is possible the patient had some degree of calcification in the aortic valve.The presence of calcification can make the pathway challenging as the delivery system crosses the valve.This can potentially lead and contribute to the reported difficulty felt when attempting to cross the aortic annulus.Also, improper guidewire management can create difficulties during navigation, tracking, and crossing of the delivery system along the guidewire.Without the return of applicable procedural imagery, there is insufficient information to determine a root cause.However, available information suggests that patient factors (calcification) may have contributed to the complaint event.No labeling, training, or ifu deficiencies were identified.Therefore, no corrective and preventative action nor pra is required at this time.For the complaint of balloon torn, potential root causes for separation of the inflation balloon to crimp balloon bond have been identified and documented in product risk assessment (pra).As identified in the pra, high forces on the system during valve alignment may result in crimp balloon tearing prior to thv deployment.Although no difficulty in valve alignment was reported, it is possible that increased forces of performing valve alignment in a non-straight section of the anatomy may have weakened the balloon and caused the balloon to tear and subsequent inability to deploy the thv.A definitive root cause is unable to be determined for the complaint of balloon torn.Available information suggests that procedural factors (valve alignment in non-straight section) may have contributed to the reported event.No labeling, training, or ifu deficiencies were identified.Therefore, no corrective and preventative action nor pra is required at this time.However, per management discretion, the balloon torn issue and its associated risks have previously been assessed and documented in a pra.The complaint balloon separated was confirmed.No manufacturing non-conformances were identified during evaluation.A definite root cause is unable to be determined.However, available information suggests procedural (withdrawal of crimped valve, excessive device manipulation) may have contributed to the reported event.No ifu/labeling/training manual inadequacies were identified.Therefore, no corrective or preventative action nor pra is required at this time.For the complaint of inability to withdraw system with valve through sheath and balloon separated, per the complaint description, ''it was tried to pull the valve back into the esheath to remove the whole system as a single unit, but it did not work because the valve was already minimally unfolded and did not fit into the esheath.Therefore, a cutdown was performed to the patient vessel to be able to remove the commander with the valve and esheath.The valve had to be cut apart for safely remove the system.'' due to the minimal unfolding of the valve during the attempted valve deployment, the profile of the valve may have been too large to retrieve back into the sheath and resulted in the reported retrieval difficulty.As a result, it's possible that the additional pull force/excessive device manipulation could have been applied to overcome the withdrawal difficulty which led to the reported separation.The available information suggest that procedural factors (withdrawal of crimped valve, excessive device manipulation) may have contributed to the reported event.No ifu/labeling/training manual inadequacies were identified.Therefore, no corrective or preventative action nor pra is required at this time.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.

• Brand Name: 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: 15262701
• MDR Text Key: 298277266
• Report Number: 2015691-2022-07433
• 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: 10/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2023
• Device Model Number: 9610TF26U
• Device Catalogue Number: N/A
• Device Lot Number: 64145183
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female