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

Model Number TA DELIVERY SYSTEM UNKNOWN

Device Problems Difficult to Remove (1528); Failure to Advance (2524)

Patient Problem Perforation of Vessels (2135)

Event Date 02/08/2022

Event Type  Death  

Manufacturer Narrative

The investigation is ongoing.The device is not returning.

Event Description

As reported, during a subclavian/axillary tavr procedure of a 23 mm sapien 3 ultra valve in the native aortic valve, the valve got stuck at the ostium of the left subclavian and the aortic arch outside of the sheath.The subclavian artery was avulsed from the arch.Some resistance was felt when the sheath was inserted.The patient expired during procedure.

Manufacturer Narrative

A supplemental mdr is being submitted for correction and additional information base on the field clinical specialist's (fcs) response.The following sections of this report have been updated: corrected h.6 device code and h10.Additional information, per the fcs, the anatomy was tortuous.Unappreciated calcification at ostium of subclavian.There was difficulty noted and the injury occurred during withdrawal.

Manufacturer Narrative

A supplemental mdr is being submitted for correction and additional information.The following sections of this report have been updated: corrected h.6 component codes and investigation conclusions.Added new information to h.6 type of investigation and investigation findings.The commander delivery system was not returned to edwards lifesciences for evaluation.Without the device returned for evaluation, visual inspection, functional testing and dimensional analysis were unable to be completed.The imagery provided by the site includes the patient's 3mensio imagery which shows the following: calcification and tortuosity are present in the patient's access vessel and both the right and left subclavian arteries are undersized.Additionally, images of the devices after the procedure were provided, the following was observed: a piece of tissue can be noted on inflation balloon, with the delivery system fully inserted through the sheath.During manufacturing, the device undergoes multiple 100% inspections.In addition, the work order underwent functional product verification testing on a sampling basis as a requirement for lot release.These inspections and tests during the manufacturing process support that it is unlikely that a non-conformance contributed to the reported complaint.The instructions for use/training manuals were reviewed for guidance/instruction involving the delivery system usage.Based on the review of the ifu/training manuals, no deficiencies were identified.A review of the risk management documentation was performed, and 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 were confirmed through the provided imagery.Due to the unavailability of the device, engineering was unable to perform any visual, functional, or dimensional analysis.Without the work order information, a review of the device history record and lot history was unable to be performed and is unable to confirm that a manufacturing non-conformance contributed to the complaint.A review of the 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.In this case, ''the valve got stuck at the ostium of the left subclavian and the aortic arch outside of the sheath.The subclavian artery was avulsed from the arch.'' the provided imagery revealed the patient's subclavian arteries were calcified, tortuosity, and undersized.As such, it is possible that the patient factors contributed to the tracking and withdrawal difficulties noted.Obstructive calcification, in addition to an undersized vessel, may have prevented the advancement of delivery system and contributed to withdrawal difficulties by reducing the vessel lumen diameter and may increase restriction and friction.Additionally, tortuosity may result in a non-coaxial insertion, further contributing to withdrawal difficulties.While a definitive root cause is unable to be determined due to lack of returned device and procedural imagery, available information suggests that patient factors (calcification, tortuosity, vessel size) may have contributed to the complaint events.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.No ifu/labeling/training manual inadequacies were identified.Therefore, no corrective or preventative action (capa) nor product risk assessment (pra) is required at this time.

• 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: 13698015
• MDR Text Key: 286834021
• Report Number: 2015691-2022-04321
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/04/2022

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: TA DELIVERY SYSTEM UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/08/2022
• Initial Date FDA Received: 03/08/2022
• Supplement Dates Manufacturer Received: 03/15/2022; 05/03/2022
• Supplement Dates FDA Received: 03/30/2022; 05/05/2022
• 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): Death
• Patient Sex: Female