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

Model Number 9750CM26A

Device Problem Difficult to Remove (1528)

Patient Problem Rupture (2208)

Event Date 01/23/2023

Event Type  Death  

Event Description

As reported by the field clinical specialist (fcs), during the transfemoral transcatheter aortic valve replacement (tavr) procedure of a 26mm sapien 3 ultra valve, there was difficulty withdrawing the delivery system with valve through the 14fr esheath+.A decision was made to withdraw the entire system due to wire position being lost during advancement of the delivery system with valve through the esheath+.There was an attempt to cross the valve again with the commander delivery system and a straight wire, but this was unsuccessful as the anatomy was 70 degrees.During the withdrawal attempt, the valve was pulled back into the esheath+, but it was not aligned resulting in the valve not going back into the esheath+.The valve was then pulled next to the esheath+ tip and the entire system was able to be withdrawn as one unit.It was then noted that a section of the patient's iliac artery had ripped.The patient's blood pressure was lost immediately.A non-edwards balloon was used to stop blood flow; however, the bleeding could not be stopped.The procedure was stopped, and the patient passed away.

Manufacturer Narrative

The investigation is ongoing.Device not available for return.

Manufacturer Narrative

A supplemental mdr is being submitted for correction and includes additional information based on investigation.The following sections of this report have been corrected/updated: h6 (type of investigation, investigation findings, investigation conclusions) and h10 (provide narrative/data).The device was not returned to edwards lifesciences for evaluation.As a result, no visual inspection, functional testing, or dimensional analysis could be performed.Imagery of the patient's anatomy was provided.Review of the imagery revealed tortuosity and calcification present within the patient's anatomy.A device history record (dhr) review was performed and did not reveal any manufacturing nonconformance issues that would have contributed to the event.A lot history review was also performed and revealed no other events relating to the reported event.The instructions for use (ifu)/training manuals were reviewed for guidance/instruction involving the valve and delivery system usage.Based on the review of the ifu/training manuals, no deficiencies were identified.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 event for difficulty withdrawing the delivery system and valve through the 14fr esheath+ was unable to be confirmed.A manufacturing non-conformance was unable to be determined.A review of the dhr and lot history did not provide any indication that a manufacturing non-conformance would have contributed to the event.A review of the ifu and training manuals revealed no deficiencies.Per the event description, "there was an attempt to cross the valve again with the commander delivery system and a straight wire, but this was unsuccessful as the anatomy was 70 degrees.During the withdrawal attempt, the valve was pulled back into the esheath+, but it was not aligned resulting in the valve not going back into the esheath+." the provided imagery of the patient's anatomy revealed tortuosity and calcification in the patient's access vessels.With a tortuous anatomy, the delivery system was likely retrieved at a non-coaxial angle through the sheath distal tip, which likely resulted in the delivery system and/or crimped valve catching onto the sheath tip during delivery system retrieval through the esheath+.In this case, a definitive root cause was unable to be determined.However, available information suggests patient factors (tortuosity) and/or procedural factors (non-coaxial withdrawal) may have contributed to the reported 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.No product risk assessment (pra) nor corrective or preventative actions are required.

• 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: 16388062
• MDR Text Key: 309679725
• Report Number: 2015691-2023-10869
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103207835
• UDI-Public: (01)00690103207835(17)241006(10)64658555
• 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
• Report Date: 03/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9750CM26A
• Device Catalogue Number: 9750CM26A
• Device Lot Number: 64658555
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2022
• 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
• Patient Sex: Female