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

Model Number 9610TF26U

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem Vascular Dissection (3160)

Event Date 01/30/2023

Event Type  Death  

Event Description

Edwards received notification from our affiliate in the united kingdom.As reported, this was a case of an implant of a 26mm sapien 3 ultra in aortic position by transfemoral approach.The patient presented with a type i bicuspid anatomy and associated aortopathy (ascending aorta).During procedure, difficulties were found when crossing the native valve.A 18mm x 40mm vacs ii balloon was used to predilate the native valve.The 26mm sapien 3 valve was advanced through the 14f esheath and a safari xs wire, but multiple unsuccessful attempts to cross the pre-dilated valve were made.A second 035 safari wire was introduced into the lv for support.A 12mm armada balloon was inflated in an attempt to assist the s3u crossing.Several unsuccessful attempts were made with commander delivery system in order to cross the native valve.Eventually this was successful using a lunderquist wire in the commander delivery system.The 26mm sapien 3 ultra valve was deployed at nominal volume using pacing at 180bpm via the lv wire and temporary pacing box.Subsequent angiogram showed a dissection of the ascending aortic above the s3u and also involving the left main stem (lms).Lms was stented after difficulty accessing due to false lumen issues.Distal flow was demonstrated.Right coronary artery (rca) angiogram performed to show patency.The patient was removed from the table after no tamponade or aortic regurgitation were shown.The patient was extubated the following morning and was recovering.Patient passed away 3 days post-procedure due to unknown reasons.As per medical opinion, the root cause of the difficulty crossing the native valve was the native valve morphology (bicuspid type i with aortopathy) and bav with 18mm balloon and buddy wire used.The root cause of the vascular dissection may have been related to the crossing difficulties.

Manufacturer Narrative

The investigation is in progress.A supplemental report will be submitted upon completion.Device not available.

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 complaint of difficulty crossing the native annulus was confirmed.Due to 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.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 complaint.A review of the ifu and training manuals revealed no deficiencies.The complaint description states, ''several unsuccessful attempts were made with commander delivery system in order to cross the native valve.Eventually this was successful using a lunderquist wire in the commander delivery system.'' per training manual ''techniques to help with crossing: make sure the wire is correctly extended at the apex, pull tension on the wire or reposition, add or remove some flex, pull the system back and re-advance, exchange for stiffer wire.'' as such it is possible the wrong wire was originally used.Additionally, the provided imagery revealed the patient's annulus was calcified.The presence of calcification can be obstructive and may make the pathway challenging as the delivery system crosses the native valve.This can also contribute to the reported difficulty when attempting to cross the native annulus and lead to the subsequent patient injury.However, a definitive root cause is unable to be determined.Available information suggests that patient (calcification) and procedural factors (wrong guidewire) contributed to the event.No labeling/ifu deficiencies were identified.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: 16418740
• MDR Text Key: 309987105
• Report Number: 2015691-2023-10986
• 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: 03/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9610TF26U
• Device Catalogue Number: N/A
• Device Lot Number: 64367229
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2022
• 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): Death; Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female