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

Model Number 9750CM26A

Device Problems Difficult to Remove (1528); Device-Device Incompatibility (2919); Difficult to Advance (2920)

Patient Problem Unspecified Vascular Problem (4441)

Event Date 01/24/2023

Event Type  Injury  

Manufacturer Narrative

The investigation is ongoing.A supplemental report will be completed upon completion.Device not available.

Event Description

Edwards received notification from a field clinical specialist that during a transfemoral tavr, wire position lost when trying to traverse the aortic arch.As reported, the patient had an extremely tortuous aorta.The delivery system was rotated when trying to traverse the aortic arch and wire position was lost.The team was unable to recross the wire, so the entire system was removed from body and new valve was prepped.During removal, the perclose (vascular closure device) was pulled when removing the valve and delivery system which caused a vascular injury at the cfa site.A covered stent was placed without complication.A new valve was prepped and implanted successfully.The patient was discharged to home.

Manufacturer Narrative

The device was not returned for evaluation as it was not available.Therefore, a no product return engineering evaluation was performed.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 complaints of delivery system withdrawal difficulty and interaction with a non-edwards device were confirmed by returned imagery.However, the complaint unable to track delivery system through anatomy was unable to be confirmed due to lack of returned device or applicable imagery.As the device was not returned for evaluation, engineering was unable to perform any visual, functional, or dimensional analysis.Therefore, a manufacturing non-conformance could not be determined.A review of the device history record, lot history, and complaint history did not provide any indication that a manufacturing non-conformance would have contributed to the complaint.A review of ifu/training materials revealed no deficiencies.For the complaint of unable to track delivery system through anatomy, as reported, ''the system was rotated when trying to traverse aortic arch and wire position lost.'' the procedural training manual advises to ''ensure the edwards logo faces upward throughout flexing and tracking'' during tracking through the aortic arch.Rotation of the delivery system as reported may cause the flex plane of the delivery system to become non-coplanar with the curvature of the aortic arch, resulting in difficulty tracking through the aortic arch.Subsequent maneuvers to track over the aortic arch may have caused loss of guidewire placement.In addition, tortuosity of the patient aortic arch was observed in provided imagery, which may have contributed to the reported difficulty crossing and inability to reacquire guidewire placement afterwards due to difficulty navigating the tortuous anatomy.A definitive root cause was unable to be determined at this time.However, available information suggests patient (tortuosity) and/or procedural factors (excessive manipulation, lost guidewire position, torqued delivery system) contributed to the reported event.For the complaints of delivery system withdrawal difficulty and interaction with a non-edwards device, as reported, ''the team was unable to recross the wire so the entire system was removed from body and new valve was prepped.The perclose was pulled when removing the valve and delivery system which did cause vascular injury.'' tortuosity of the patient access vessels was observed in provided imagery, which may have contributed to the reported difficulty during withdrawal.The presence of tortuosity can result in the creation of sub-optimal angles during delivery system withdrawal that may lead to non-coaxial alignment.Such non-coaxiality can contribute to withdrawal difficulties as the delivery system or crimped valve can snag on the sutures of the closure device, as observed.Available information suggests that patient (tortuosity) and/or procedural factors ( non-coaxial withdrawal, interaction with non-edwards device (perclose)) may have contributed to the complaint events.No device or labeling problem was identified during the evaluation.Therefore, no further escalation (capa/scar/pra) is required.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: 16393927
• MDR Text Key: 309755620
• Report Number: 2015691-2023-10899
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103207835
• UDI-Public: (01)00690103207835(17)240918(10)64609683
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9750CM26A
• Device Catalogue Number: N/A
• Device Lot Number: 64609683
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/29/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/19/2022
• 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 Sex: Male