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

Model Number 9610TF26U

Device Problem Failure to Advance (2524)

Patient Problem Vascular Dissection (3160)

Event Date 09/05/2023

Event Type  Death  

Manufacturer Narrative

Investigation is ongoing.H3 other text: discarded.

Event Description

Per report received from united kingdom, it was a case of an implant of a 26mm sapien 3 ultra valve, in aortic position by transfemoral approach.The vessel was pre-dilated carefully with a 14f esheath dilator, because it was observed by echo that vascular access was moderately calcified, and then 14f esheath advanced without significant resistance.Lunderquist wire used for extra support.The valve was crimped as usual.While advancing the commander ds with the crimped valve through esheath, it was noticed a degree of resistance, which was expected considering the challenges of native anatomy.Despite this resistance, the commander ds could arrive to the abdominal aorta, but did not advance any further.Patient suffered chest pain and back pain.It was noted that the valve was not stuck in the aneurysmatic part of abdominal aorta by fluoroscopy.The patient decompensated rapidly and invasive pressures dropped from 110/60 to 40/20, then 30/20mmhg.Then, it was confirmed to be a dissection of the aneurysm/abdominal aorta.Vascular and cardiothoracic surgeons were called.8mg adrenaline was given to the patient.Patient passed away on the table.No damage was observed in esheath, ds or valve.As per medical opinion, the root cause of this event was a very tortuous and complex vascular anatomy and a tear in the abdominal aneurysm.

Manufacturer Narrative

A supplemental mdr is being submitted due to engineering evaluation.The event reported is an anticipated in the risk management documentation for transcatheter heart valve procedures.A previous investigation into this type of event is captured in an edwards lifesciences technical summary and applies to this complaint.Additional assessment of the failure mode is not required at this time.Due to the unavailability of the complaint device, engineering was unable to perform any visual inspection, functional testing, or dimensional analysis.Per the technical summary, the ifu, current risk mitigations include design and manufacturing controls, and training manuals have been reviewed, no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.Imaging was provided and the following was observed: calcification present in the native aorta and tortuosity was visible at the access vessel.In this case, the complaint for "unable to track system through anatomy" was unable to be confirmed.Available information suggests patient factors (calcification, tortuosity) likely contributed to the event.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.Since no edwards product defects or labeling deficiencies were identified, no corrective or preventative action is 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: 17849299
• MDR Text Key: 324657388
• Report Number: 2015691-2023-16458
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 11/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9610TF26U
• Device Lot Number: 65069622
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2023
• 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; Death
• Patient Age: 80 YR
• Patient Sex: Male