MAUDE Adverse Event Report: EDWARDS LIFESCIENCES COMMANDER DS WITH SAPIEN 3; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9750CM23A

Device Problems Difficult to Advance (2920); Material Integrity Problem (2978)

Patient Problem Great Vessel Perforation (2152)

Event Date 11/22/2022

Event Type  Injury  

Manufacturer Narrative

Investigation is ongoing.

Event Description

As reported by a field clinical specialist, a patient underwent an unsuccessful transfemoral tavr procedure with a 23mm sapien 3 ultra in the aortic position.The patient had a tortuous and calcified aorta.During the procedure, the commander delivery system would not track the amplatz super stiff wire.While advancing the thv and delivery system over the aortic arch, excessive forward tension was used and the delivery system "buckled" in the descending aorta and perforated the descending aorta.The entire system was removed, cpr was given, ecmo was attempted.The patient did not recover.As per follow-up with the fcs, the aorta was in the shape of a question mark and had suggested numerous times for the physician to use a stiffer wire to straighten out the aorta and help the ds track the wire.The physician ultimately decided to use the wire they normally use, amplatz super stiff, which in their opinion did not support the ability to track the wire.The physician aggressively advanced the ds and the tension was in the descending aorta.The ds basically bent and the sharp angle penetrated the aorta.The "buckling" occurred approximately 8 inches proximal to the thv and balloon on the dark blue ds shaft.The angle of insertion was not steep.Per the fcs, the perceived root cause of the death is believed to be the perforation in the descending aorta which caused irreversible massive bleeding before the emergency team had ecmo stabilized and an aortic occlusion balloon ready.

Manufacturer Narrative

The device was returned to edwards lifesciences for evaluation.The visual inspection of the returned delivery system revealed the following: the flex shaft was kinked approximately 9.5" from the flex tip, there was no braiding exposed at the flex shaft kink, and gouges were observed on the flex tip.Dimensional testing was not performed due to the nature of the complaint.Functional testing was performed and revealed that engineering attempted to advance a sample guidewire through the delivery system.Initially, engineering was unable to advance the guidewire through the kink.However, after flushing the delivery system, engineering was able to advance the guidewire successfully fully through the delivery system.Imagery was provided from the complaint event site and the following was observed: the patient's femoral arteries were calcified and tortuous, the patient's abdominal aorta and aortic arch were calcified and tortuous, after the device was removed from the patient, the flex shaft was curved and kinked.As such, the complaint for "general risk - failure - flex shaft cracked/damaged" is confirmed.Cine video illustrated the delivery system's inability to advance.As such, the complaints for "introduce and navigate system through sheath / access vasculature - resistance with guidewire - unable/difficult to advance" and "navigate and position catheter to target location - unable to track system through anatomy" are confirmed.The complaints for "introduce and navigate system through sheath / access vasculature - resistance with guidewire - unable/difficult to advance," "navigate and position catheter to target location - unable to track system through anatomy," and "general risk - failure - flex shaft cracked/damaged" were confirmed by the upon review of the provided imagery.No manufacturing non-conformances were identified during engineering evaluation.A review of the device history record, lot history, and complaint history did not provide any indication that a manufacturing non-conformance would have contributed to the complaint.A review of the ifu and training manuals revealed no deficiencies.The complaint description states, "the patient had a tortuous and calcified aorta.During the procedure, the commander delivery system would not track the amplatz super stiff wire.While advancing the thv and delivery system over the aortic arch, excessive forward tension was used and the delivery system "buckled" in the descending aorta and perforated the descending aorta." the provided imagery revealed the patient's access vessels, aortic arch, and abdominal aorta were calcified and tortuous.The sub-optimal angles created by the patient's anatomy can lead to difficulty delivery system insertion that may lead to non-axial alignment or a kink in the guidewire that contributes to resistance of the delivery system.In addition to a kinked guidewire, obstructive calcification or tortuosity may have prevented the advancement of delivery system.The delivery system may have interacted with calcium nodes in the advancement pathway and the system was unable to be advanced further.Additionally, tortuous anatomy can present difficult bend angles for the devices to overcome.Furthermore, excessive manipulation was likely applied to the delivery system to overcome the observed resistance, consequentially resulting in the observed flex shaft kink.As such, available information suggests that patient (calcification, tortuosity) and procedural factors (kinked guidewire, excessive manipulation) may have contributed to the complaint events.The ifu and training manuals have been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.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.

• Brand Name: COMMANDER DS WITH SAPIEN 3
• 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: 15991097
• MDR Text Key: 305582360
• Report Number: 2015691-2022-10034
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103207828
• UDI-Public: (01)00690103207828(17)240824(10)64555335
• 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
• Report Date: 02/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9750CM23A
• Device Catalogue Number: 9750CM23A
• Device Lot Number: 64555335
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/25/2022
• 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): Hospitalization; Required Intervention; Death
• Patient Age: 87 YR
• Patient Sex: Female
• Patient Weight: 58 KG