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

Model Number 9610TF29

Device Problems Difficult or Delayed Positioning (1157); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Tamponade (2226); Vascular Dissection (3160)

Event Date 04/04/2024

Event Type  Death  

Event Description

Edwards received notification from our affiliate in brazil.As reported, it was a 29mm sapien 3 ultra transcatheter heart valve implant in aortic position by transfemoral approach.The ascending aorta was calcified, tortuous and dilated.During procedure, difficulties to cross the native anulus were found and the patient suffered an ascending aortic dissection.Patient developed cardiac tamponade, blood drainage and resuscitation maneuvers were performed.The sapien 3 ultra valve was not implanted.Patient passed away.

Manufacturer Narrative

The investigation is in progress.A supplemental report will be submitted upon completion.

Manufacturer Narrative

The event reported is an 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.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 mitigation's 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.The commander delivery system is designed to be compatible with a standard 0.035'' guidewire to enhance trackability.The nose tip is designed to be atraumatic and provide better anatomical crossing, while providing a gradual dimensional increase.Articulation of the system is also instrumental in trackability to the target treatment zone.The ability to articulate allows the catheter to traverse the aortic arch over an 0.035'' guidewire with minimal interaction between the delivery system nosecone, crimped thv, patient vasculature and calcification that may be present.Flex/articulation is designed to occur in one direction with minimal deflection from the flex plane.Catheter deflection angle, and deflection plane are verified for effectiveness.Flexion of the commander delivery system is validated, as articulation of the system is also instrumental in navigation through the anatomy to the target treatment zone while minimizing vascular interaction, including traversing the aortic arch, as well as crossing the native or surgical bioprosthetic in the most achievable, non-biased form.System materials are specified through design requirements, while manufacturing and packaging procedures include 100% inspection for loose fragments.Edwards has provided guidelines and instructions to physicians on visualization, assessment, and preservation of the vasculature, adequate preparation of the vasculature, the optional use of predilitation of the target valve, and proper use of flexion while performing navigation through the anatomy in the ifu and training materials/refresher training.In addition, edwards physician training program includes case observation/review, proctor qualification and refresher training.Review of prior closed similar complaints that were able to be confirmed indicates that patient and/or procedural factors can contribute to difficulty or inability in tracking the delivery system to the landing zone, including traversing the aortic arch and crossing the native annulus/bioprosthesis.Patient factors such as calcification, tortuosity, small vessel size, or preexisting vascular stent may cause constrained sections of the anatomy that interferes with passage of the delivery system and causes difficulty during tracking.Proper use of the guidewire is important as it serves to guide the delivery system during tracking and crossing of the anatomy.As such, poor guidewire positioning and/or loss of guidewire placement may cause the delivery system to interact with patient anatomy, leading to difficulty tracking/crossing.In this case, the complaint was unable to be confirmed.Investigation results suggest/indicate patient factors (calcification, tortuosity) may have caused or contributed to the reported inability to cross native annulus.No edwards defect or manufacturing non-conformance that would have contributed to the reported event was identified.No ifu/training deficiencies were identified.Since no edwards product defects or labeling deficiencies were identified, no corrective or preventative action is required.Complaint histories s 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.

• 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: 19197768
• MDR Text Key: 341235855
• Report Number: 2015691-2024-03199
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103193008
• UDI-Public: (01)00690103193008(17)250109(11)230110
• 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,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/23/2024

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 Model Number: 9610TF29
• Device Catalogue Number: N/A
• Device Lot Number: 64823358
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/04/2024
• Initial Date FDA Received: 04/26/2024
• Supplement Dates Manufacturer Received: 05/22/2024
• Supplement Dates FDA Received: 05/23/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/10/2023
• 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; Required Intervention