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

Model Number 9600LDS29A

Device Problems Fracture (1260); Difficult to Remove (1528); Device Dislodged or Dislocated (2923)

Patient Problems Foreign Body Embolism (4439); Insufficient Information (4580)

Event Date 03/16/2022

Event Type  Death  

Manufacturer Narrative

Investigation is ongoing.

Event Description

During an tavr procedure with a 29mm sapien 3 valve using transfemoral approach, the valve was crossed.With the pusher pulled back, rapid pacing was initiated.The valve slipped between the annulus and too deep to deploy.Attempts to re-position were unsuccessful and pacing was halted.The patients' blood pressure dropped and cardiopulmonary resuscitation (cpr), pressors and extracorporeal membrane oxygenation (ecmo) were initiated.The valve and delivery system were attempted to be removed through the 16 fr esheath and could not be withdrawn due to resistance felt.It was observed that the valve had embolized into the descending aorta and that the balloon had broken at the bond of the shaft and had separated with material getting caught on an artery.The patient had bleeding in the lungs due to cpr and the patient expired.

Manufacturer Narrative

A supplemental mdr is being submitted for correction and additional information based on investigation.The following sections of this report have been updated: h6 (component code, type of investigation, investigation findings, investigation conclusions) and h10 (provide narrative/data) and h8 usage of device.The commander delivery system was not returned to edwards lifesciences for evaluation; therefore, no visual inspection, functional testing and dimensional testing is applicable.A 3mensio was provided and reviewed which indicated calcification around the annulus, tortuous access vasculature and descending aorta, borderline horizontal aorta.A device history record (dhr) review was done and did not reveal any manufacturing nonconformance issues that would have contributed to the event.A lot history review was performed and revealed complaints relating to the complaint code.However, lot history review did not provide any indication that a manufacturing non-conformance would have contributed to the complaint event.The instructions for use (ifu) were reviewed for guidance/instruction involving valve and delivery system usage and no ifu/training 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 complaints for withdrawal difficulty and balloon tear were unable to be confirmed as the device was not returned and no applicable imagery was provided.Available information suggests that procedural factors (over-alignment) may have contributed to the complaint events.To overcome the withdrawal difficulty felt, excessive manipulation of the delivery system may have been used and lead to the reported event of balloon torn.Additionally, it was reported that torn balloon was noticed during withdrawal attempts, which may have contributed to the delivery system catching onto the sheath tip during withdrawal attempts, resulting in the withdrawal difficulty reported.However, a definitive root cause was unable to be determined.Due to the 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 and lot history did not provide any indication that a manufacturing non-conformance would have contributed to the complaint event.A review of the ifu and training manuals revealed no deficiencies.In this case, due to limited information, a conclusive root cause was unable to be determined.However, information suggests that patient (tortuosity) and/or procedural factors (non-coaxial withdrawal, valve not against flex tip) may have contributed to the complaint events.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: 14021945
• MDR Text Key: 288671474
• Report Number: 2015691-2022-04863
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103193961
• UDI-Public: (01)00690103193961(17)230902(10)63983043
• 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: 05/13/2022

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 Expiration Date: 09/02/2023
• Device Model Number: 9600LDS29A
• Device Catalogue Number: 9600LDS29A
• Device Lot Number: 63983043
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/16/2022
• Initial Date FDA Received: 04/06/2022
• Supplement Dates Manufacturer Received: 05/13/2022
• Supplement Dates FDA Received: 05/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2021
• 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
• Treatment: ESHEATH.
• Patient Outcome(s): Death
• Patient Age: 74 YR
• Patient Sex: Male