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

Model Number	9600LDS29A
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is ongoing.This is one of two manufacturer reports being submitted for this case.Please reference related manufacturer report no: 2015691-2024-09318.
Event or Problem Description
As reported by an edwards lifesciences field clinical specialist, a 29mm sapien 3 valve was to be implanted in the aortic position via transfemoral approach.The 16fr esheath+ was inserted without issue.A bav was performed without issue.There was resistance when inserting the commander delivery system through the expandable portion of the sheath.It was noticed that the delivery system was stuck within the sheath at the area of the aorta-iliac bifurcation.An injection showed extravasation and what seemed like the valve being outside of the liner of the sheath.Attempts at buddy balloon, snaring, pushing and pulling the sheath, and turning the delivery system to free the valve were performed.At this point the pusher and the valve were no longer touching, however, the valve remained crimped on the balloon.The patient's blood pressure began to soften, so vascular surgery was called.The patient was receiving blood products and increasing support.As the delivery system could only move forward, the devices could not be withdrawn.Vascular surgery was able to pull the sheath back a fair amount, which allowed the delivery system and valve to be pushed through the tip of the sheath.Valve alignment was quickly performed, and the 29mm sapien 3 valve was deployed in the descending aorta below the renal arteries.The delivery system and sheath were removed as a unit.It was observed that the liner of the sheath was split.Another set of devices were prepped to continue with the tavr procedure, but prior to introducing the devices, the patient coded, and volume was depleted.The patient was resuscitated, and the procedure was aborted.After the devices were removed, there was bleeding at the site and in the external.Kissing stents were placed.Pressure was held for 30 minutes.The patient ultimately received 5-6 units of blood, was on high dose vasopressors, and intubated.The patient was stable and was transferred to icu.The patient will return later for tavr, using a different access site.
Additional Manufacturer Narrative
A supplemental mdr is being submitted for correction and additional information based on the engineer evaluation.The following sections of this report have been updated: additional codes added to h6 type of investigation, corrected h6 investigation findings, corrected h6 investigation conclusions, and additional information added to h10 related report numbers.The event reported is anticipated in the risk management documentation for transcatheter heart valve procedures.A previous investigation into this type of event is captured in an edwards lifesciences technical summary and applies to this complaint.Additional assessment of the failure mode is not required at this time.The device was not returned.Due to the unavailability of the complaint device, engineering was unable to perform any visual inspection, functional testing, or dimensional analysis.Per the technical summary, the ifu, current risk mitigations include design and manufacturing controls, and training manuals have been reviewed, no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.Imagery was provided by the field and the following was observed: sheath liner tear along what appears to be the full length of the liner.Calcification and tortuosity in patient vasculature.Through extensive complaint investigations, events reporting difficulty/inability withdrawing catheter with crimped valve through patient vasculature or through the sheath have not been associated with device malfunctions or manufacturing nonconformances.Rather, the root cause for these events have historically been due to patient factors, non-coaxial withdrawal, altered crimp profile, damaged sheath, not centering the thv on the flex tip, and/or withdrawing the thv through the sheath hub.The difficulty withdrawing the delivery system with the valve through the sheath was unable to be confirmed.Available information suggests patient (calcification, tortuosity) and procedural factors (non-coaxial withdrawal, withdrawal through damaged sheath).Patient factors (i.E.Calcification, tortuosity) as observed in provided imagery may cause constrained sections of the anatomy that interferes with passage of the delivery system and causes difficulty during withdrawal.Proper withdrawal technique is important, as non-coaxial withdrawal of the delivery system with crimped thv may cause the system or thv to interact with vasculature or the sheath, resulting in difficulty withdrawing.If the sheath was previously damaged, such as liner tear as observed it can cause further resistance as the delivery system with crimped thv is withdrawn into it.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.Since no edwards product defects or labeling deficiencies were identified, no corrective or preventative action is required.

• Brand Name: EDWARDS COMMANDER DELIVERY SYSTEM
• Common Device Name: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 20859565
• Report Number: 2015691-2024-09319
• Device Sequence Number: 4058526
• Product Code: NPT
• UDI-Device Identifier: 00690103193961
• UDI-Public: (01)00690103193961(17)260509(10)65756458
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P140031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/09/2026
• Device Model Number: 9600LDS29A
• Device Catalogue Number: N/A
• Device Lot Number: 65756458
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2024
• Supplement Date Received by Manufacturer: 01/27/2025
• Initial Report FDA Received Date: 12/05/2024
• Supplement Report FDA Received Date: 01/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/09/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Male