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

Model Number 9610TF26U

Device Problems Nonstandard Device (1420); Device Difficult to Setup or Prepare (1487)

Patient Problem Insufficient Information (4580)

Event Date 07/06/2023

Event Type  Death  

Event Description

As reported by an edwards lifesciences affiliate in france, during an urgent tavr procedure with a 26mm sapien 3 ultra transcatheter heart valve, the team was unable to prepare the commander delivery system due to unknown reasons.Another commander delivery system was prepared but the valve could not be implanted because the patient passed away on the table.Per the initial reporter "the patient passed away on the table due to the time lost waiting to prepare the device".Per initial engineering evaluation of the returned device, no abnormalities or defects were noted.Multiple attempts have been made to obtain additional information however the hospital will not be providing further information.The cause of death and status of the patient prior to the procedure remains unknown.This event is being conservatively reported.

Manufacturer Narrative

The investigation is ongoing.

Manufacturer Narrative

The delivery system was returned for evaluation.During manufacturing of the commander delivery system, the delivery system and components are inspected several times throughout the manufacturing process.In addition, product verification testing was performed on a sampling basis and all testing met specifications.These inspections performed during manufacturing process and testing performed during product verification support that it is unlikely that a manufacturing non-conformance contributed to the reported events.During visual inspection, no visual abnormalities were noticed on the delivery system, including the balloon.An inflation test was performed on the returned device.The balloon was inflated as expected with and without the received stopcock attached at inflation port.No leakage was observed.The ifu and device preparation manual were reviewed and no ifu or training deficiencies were identified.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.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.Since no device problem was identified affecting distributed product, no pra is required.Additionally, since no edwards defect, which could have resulted in the complaint, was confirmed, no preventative or corrective actions are required.The delivery system prepping difficulty was unable to be confirmed.Functional testing of the returned delivery system suggests no device defect.A review of ifu/training materials revealed no deficiencies.Per the event description, ''during device prep, a leakage in the commander delivery system balloon was noted before the valve was placed.'' however, during product evaluation, no abnormalities were noticed on the balloon or delivery system during evaluation., balloon inflated as intended and no leakage was observed.As no device defect was noted during the evaluation, a definitive root cause is unable to be determined 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 (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: 17687517
• MDR Text Key: 322694703
• Report Number: 2015691-2023-15734
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2023
• 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: 64979921
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2023
• 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): Death
• Patient Sex: Female