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

Model Number 9610TF29

Device Problems Difficult to Remove (1528); Material Split, Cut or Torn (4008)

Patient Problem Unspecified Vascular Problem (4441)

Event Type  Injury  

Event Description

As reported, it was a case of an implant of a 29mm sapien 3 thv in aortic position by transfemoral approach.It was mentioned that it was seen "the overdrive of the pusher into the valve".Before valve deployment, when operator tried to pull the pusher back to release the balloon, it could not be done after several attempts.Operator was unable to separate the pusher from the valve and decided to remove the devices.While trying to remove them, the valve could not be pulled into the esheath.It was tried to bring the valve (uncovered) in the iliac for a vascular intervention, and as a consequence, the iliac was damaged and there was heavy bleeding.The situation was managed on table with the help of vascular surgeon and the tavi procedure was aborted.However, after five days the patient died due to infection.

Manufacturer Narrative

Investigation is ongoing.Device information is unknown.Discarded.

Manufacturer Narrative

The device was not returned to edwards lifesciences for evaluation.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 event is not required at this time.The complaint for "navigate and position catheter to target location - valve alignment difficulty or inability - unknown" was confirmed by the provided imagery.The complaints for "withdraw catheter and valve through vasculature / sheath - difficulty or inability to withdraw system with valve through sheath" and "general risk - resistance between catheter shafts" were unable to be confirmed.Due to the unavailability of the device, engineering was unable to perform any visual, functional, or dimensional analysis; therefore, a manufacturing non-conformance was unable to be determined.Additionally, due to unavailability of work order, review of the device history record and lot history was not performed.Therefore, a manufacturing non-conformance could not be determined.A review of the ifu and training manuals revealed no deficiencies.The complaint description states, "it was mentioned that it was seen 'the overdrive of the pusher into the valve.' before valve deployment, when operator tried to pull the pusher back to release the balloon, it could not be done after several attempts.Operator was unable to separate the pusher from the valve and decided to remove the devices.While trying to remove them, the valve could not be pulled into the esheath." if valve alignment was performed in a non-straight of vasculature, this can cause the valve to become unseated (non-coaxial placement of valve in relation to the flex tip) and "dive" into the flex tip.Valve diving was observed in the provided imagery.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.Furthermore, the built-up tension in the system may have led to the compression of the device causing the difficulties with retracting the flex tip.Additionally, the presence of tortuosity can create suboptimal angles and lead to non-coaxial alignment between the valve and sheath tip during withdrawal.As the valve remained crimped on the balloon during retrieval, it can get caught on the sheath tip and contribute to withdrawal difficulties.A definitive root cause is unable to be determined at this time.However, available information suggests that patient (tortuosity) and procedural (performing valve alignment in non-straight section, built-up tension, non-coaxial withdrawal) factors may have contributed to the complaint event.No ifu/labeling/training manual inadequacies were identified.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.Therefore, no corrective or preventative action nor pra is required at this time.

• 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: 16288123
• MDR Text Key: 308702471
• Report Number: 2015691-2023-10528
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9610TF29
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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