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

Model Number 9610TF29

Device Problems Difficult to Remove (1528); Failure to Align (2522)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/23/2023

Event Type  Injury  

Manufacturer Narrative

Investigation is ongoing.

Event Description

As reported from our affiliates in germany, this was a case of an implant of a 29mm sapien 3 valve in aortic position by transfemoral approach.During the alignment in the descending aorta, it was not possible to load the valve onto the balloon and it was decided to remove the system.The delivery system and the esheath were retrieved as a single unit.A femoral cutdown was needed to retrieve the system.A new 29mm sapien 3 kit was used in replacement and the valve was successfully implanted.The patient was noted to be doing fine after the procedure.The patient presented a severe tortuosity in the descending aorta.No abnormalities were observed in the ds nor the esheath prior to insertion.As per medical opinion, the root cause of the inability to load the valve onto the balloon was the tortuosity of the descending aorta.

Manufacturer Narrative

The returned device was visually inspected and following were observed: there were scratches at the distal part of the flex shaft.There were gouges on the flex tip.Upon receiving, engineering was able to perform full valve alignment by pulling full gross alignment, locking the device, and utilizing full fine adjustment without resistance.After the decontamination process, engineering was again able to perform full valve alignment by pulling full gross alignment, locking the device, and utilizing full fine adjustment without resistance.Furthermore, the locknut/collet engagement force was tested when the balloon is locked at warning marker, which met device specifications without slippage.The complaints for valve alignment difficulty or inability and difficulty or inability to withdraw system with valve through sheath were unable to be confirmed as applicable imagery was not provided.No manufacturing non-conformances were identified during engineering evaluation.A review of dhr and lot history did not provide any indication that a manufacturing non-conformance would have contributed to the complaint event.A review of the ifu and training manuals revealed no deficiencies.As reported, "during the procedure, the physician felt resistance advancing the delivery system with the crimped valve through the esheath.During the alignment in the descending aorta, it was not possible to load the valve onto the balloon and it was decided to remove the system." additionally reported, "the patient presented a severe tortuosity in the descending aorta." if valve alignment was performed in tortuous anatomy or a non-straight section, 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, as reported.If the transcatheter heart valve 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, tortuosity can render sub-optimal angles during delivery system withdrawal, leading to non-coaxial alignment.Such non-coaxiality could have caused the crimped valve to negatively interact and/or catch on the sheath tip during withdrawal attempts, preventing system retrieval back into the sheath.However, without applicable procedural imagery, a definitive root cause is unable to be determined.Available information suggests that patient (tortuosity) and/or procedural factors (valve alignment in non-straight section, withdrawal of crimped valve) may have contributed to the complaint event.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.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.As such, neither a product risk assessment, nor corrective or preventative actions are required at this time.

• 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
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 16418373
• MDR Text Key: 309979396
• Report Number: 2015691-2023-10983
• 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: 04/27/2023

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 Model Number: 9610TF29
• Device Catalogue Number: N/A
• Device Lot Number: 64771197
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/30/2023
• Initial Date FDA Received: 02/22/2023
• Supplement Dates Manufacturer Received: 04/27/2023
• Supplement Dates FDA Received: 04/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/22/2022
• 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