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

Model Number COMMANDER DELIVERY SYSTEM

Device Problems Difficult or Delayed Positioning (1157); Difficult to Remove (1528); Device Slipped (1584); Failure to Align (2522); Material Split, Cut or Torn (4008)

Patient Problem Unspecified Vascular Problem (4441)

Event Date 08/21/2023

Event Type  Death  

Manufacturer Narrative

Investigation is ongoing.Device not returned.

Event Description

As reported, patient was accessed via carotid and due to short ascending a portion of alignment was done in sheath.When the valve was pushed out of the sheath and they started the fine tuning the delivery system starting bending at the area near the stent and delivery system so they pulled negative on balloon to see if the bond was broken and there was no blood.They advanced the delivery system across the aortic valve and when unsheathed the stent pulled back close to the middle marker.They tried to see if the balloon would inflate, but contrast went into the patients body and blood came back into the indeflator, the valve would not come back into the sheath, even with changing positioning in aorta and slightly rotating the sheath.They decided to try and put valve against the sheath and pull out as one unit and met resistance at the ostium of the left carotid, the sheath/valve combo came uncoupled so they opened up further to get valve out surgically, gave the valve a small tug and the artery avulsed and came out with the system.It was noted that the three tabs at the bond were up and the distal portion of the valve stent was flared; the area of transition between the balloon and the balloon catheter was the distal portion, the tabs that pop out when the balloon is no longer connected to the balloon catheter were up.The carotid vessels were straight, but small.Angulation of the aorta was 38 degrees.They attempted to balloon occlude for repair, but the non edwards balloon would not provide occlusion even with a 8-9mm ostium - vessel 6mm and patient expired.

Manufacturer Narrative

Supplemental report submitted to include additional information received through follow-up.The device was not returned for evaluation as it was discarded.Therefore, a no product return engineering evaluation was performed.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 fine adjust valve alignment difficulty, balloon torn, withdraw difficulty, and valve moves on balloon were unable to be confirmed due to unavailability of the returned device and/or applicable imagery.Engineering was unable to perform any visual examination, 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.An existing edwards technical summary has been documented for root cause analysis for valve alignment difficulty and secondary failures due to tension build up in the system, resulting in the reported valve movement on balloon, balloon torn and withdrawal difficulty.The technical summary provides a rationale as to why it is unlikely that a product defect or manufacturing non-conformance contributed to this type of event.Per provided 3mensio, patient had tortuosity in access vessels.If valve alignment was performed in a tortuous vasculature (non-straight section), this could have caused the valve to become unseated (non-coaxial placement of valve in relation to the flex tip) and ''dive'' into the flex tip.If the thv was unseated from the flex tip during alignment, it could have resulted in higher-than-normal alignment forces creating high tension in the system, which could have consequentially led to the reported valve alignment difficulties.Additionally, high forces on the system during valve alignment may result in crimp balloon tearing prior to thv deployment, creating a leak pathway as reported.The release of built-up tension within the delivery system during the procedure may have resulted in the reported valve movement on balloon.Tortuous patient anatomy could result in non-coaxial angles of withdrawal during system retrieval.It is possible that the non-coaxial withdrawal configuration in combination with altered balloon profile (torn) may have resulted in the crimped thv interacting with patient vasculature and causing the reported withdrawal difficulty.In addition, the technical summary outlines the extensive manufacturing mitigations in place to prevent this type of malfunction (visual and dimensional inspections, leak testing, and functional testing that occurs with every manufactured lot).These inspections and testing further support that it is unlikely that a defect present in manufacturing contributed to the complaint.The technical summary also outlines the instructions for valve deployment.It should be noted that these mitigations are still in place.In this case, review of available information suggests that patient factors (tortuosity) and/or procedural factors (valve alignment in the non-straight section, built up tension) contributed to the valve alignment difficulty, valve movement on balloon and balloon torn while procedural factors (non-coaxial withdrawal, withdrawal of torn balloon) contributed to the withdrawal difficulty.These events contributed to the patient death.No device or labeling problem was identified during the evaluation.Therefore, no further escalation (capa/scar/pra) is required.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.

Event Description

Edwards received notification from a field clinical specialist that a patient underwent trans carotid tavr.As reported, a portion of valve alignment was done in sheath due to short ascending anatomy.The alignment was completed with the fine adjustment knob while inside of the sheath causing the delivery system to bend inside the sheath showing the extreme tension on the system.When the valve was pushed out of the sheath and the team began the fine tuning the delivery system, it started bending at the area near the stent and delivery system.Then the flex catheter was retracted, the valve came with it with the distal portion of the valve stent being at the middle marker.The team pulled negative on the balloon to see if the bond was broken and there was no blood.They tried to see if the balloon would inflate, but contrast went into the patient's body and blood came back into the indeflator.The valve would not come back into the sheath, even with changing positioning in aorta and slightly rotating the sheath.They decided to try and put valve against the sheath and pull out as one unit and met resistance at the ostium of the left carotid, the sheath/valve combo came uncoupled so they opened up further to get valve out surgically, gave the valve a small tug and the artery avulsed and came out with the system.It was noted that the three tabs at the bond were up and the distal portion (the area of transition between the balloon and the balloon catheter) of the valve stent was flared (the tabs that pop out when the balloon is no longer connected to the balloon catheter, were up).The carotid vessels were straight, but small.Angulation of the aorta was 38 degrees.The team attempted to balloon occlude for repair, but the 10mm balloon would not provide occlusion even with a 8-9mm ostium and 6mm vessel.The patient then expired.

• 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 MN 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 17754368
• MDR Text Key: 323471656
• Report Number: 2015691-2023-15957
• Device Sequence Number: 1
• Product Code: NPT
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: COMMANDER DELIVERY SYSTEM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 69 YR
• Patient Sex: Male