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

Model Number 9600LDS29A

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Unspecified Vascular Problem (4441)

Event Date 07/29/2022

Event Type  Injury  

Manufacturer Narrative

Investigation is ongoing.

Event Description

As reported by field clinical specialist, a patient underwent a percutaneous transfemoral tavr procedure with a 29mm sapien 3 ultra valve in the aortic position.During the procedure, they lost wire access in the left ventricle and decided to remove the entire system.However, during withdrawal, the sheath was pulled back outside the vessel prior to the delivery system removal.They felt there was a vascular injury.Hemostat was used for blunt dissection of the subcutaneous tissue for removal of the system.Per follow-up, the team advised that the commander delivery system may have caught on the vessel during removal resulting in the vascular injury.The sheath was replaced and upsized to a non-edwards sheath.A new system was prepped in normal fashion.The valve was advanced through the non-edwards sheath without incident and deployed as intended and without complication.The patient was being seen by a vascular surgeon for common femoral repair and was in stable condition.

Manufacturer Narrative

A supplemental mdr is being submitted due to engineering evaluation findings.Sections b4, g3, g6, h2, h6: type of investigation, investigation findings, investigation conclusions and h10 has been updated.The device was not returned to edwards lifesciences for evaluation.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 this event is not required at this time.The complaint for difficulty or inability to withdraw system with valve through sheath was unable to be confirmed.As the device was not returned, engineering was unable to perform any visual inspection, functional testing, or dimensional analysis.Therefore, the presence of a manufacturing non-conformance was unable to be determined.A review of ifu/training materials revealed no deficiencies.Furthermore, no abnormalities were reported during device unpacking or preparation.Per complaint description, -during the procedure, they lost wire access in the left ventricle and decided to remove the entire system.However, during withdrawal, the sheath was pulled back outside the vessel prior to getting the delivery system into the sheath.They felt there was a vascular injury.Hemostat was used for blunt dissection of the subcutaneous tissue for removal of the system.Per follow-up, the team advised that the commander delivery system may have caught on the vessel during removal resulting in the vascular injury.- 3mensio of patient anatomy was provided and showed no abnormal or severe degree of tortuosity or calcification.Per training manual, -withdraw the delivery system and sheath as a single unit completely from the arteriotomy while maintaining guidewire position.- if the sheath is not removed as a unit with the delivery system and valve, the struts of the valve can be exposed to the vasculature and potentially catch onto the patient-s anatomy when attempting remove the delivery system, as what was reported.Available information suggests that procedural factors (inadvertently removing only the sheath) may have contributed to the complaint event.A definitive root cause is unable to be determined.No ifu/labeling/training manual inadequacies were identified.Therefore, no corrective or preventative action nor pra is required at this time.

• Brand Name: EDWARDS COMMANDER DELIVERY
• 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: 15287610
• MDR Text Key: 298561495
• Report Number: 2015691-2022-07494
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103193961
• UDI-Public: (01)00690103193961(17)231124(10)64121121
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/14/2022

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: 11/24/2023
• Device Model Number: 9600LDS29A
• Device Catalogue Number: 9600LDS29A
• Device Lot Number: 64121121
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/29/2022
• Initial Date FDA Received: 08/24/2022
• Supplement Dates Manufacturer Received: 09/09/2022; 10/13/2022
• Supplement Dates FDA Received: 10/04/2022; 10/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/24/2021
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male