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

Model Number 9610TF29

Device Problems Difficult or Delayed Positioning (1157); Inflation Problem (1310); Failure to Align (2522); Difficult to Advance (2920); Positioning Problem (3009); Material Split, Cut or Torn (4008)

Patient Problems Calcium Deposits/Calcification (1758); Death (1802); Injury (2348)

Event Date 04/07/2020

Event Type  malfunction  

Manufacturer Narrative

Edwards lifesciences continues to investigate the reported event and a supplemental report will be submitted in accordance with 21 cfr 803.56 when additional information becomes available.This is one of two manufacturer reports being submitted for this case.

Event Description

As reported by our affiliate in the united kingdom, during a difficult transfemoral tavr procedure, resistance was felt while inserting and advancing the 16fr, esheath into the patient.No pre-dilation of the vessels was performed.Issues were also encountered when the 29mm sapien 3 valve and commander delivery system were advanced through the sheath.Advancement problems were encountered, however after some manipulations the valve successfully moved through the sheath.While at a straight section of descending aorta during alignment, the valve could not be aligned because the balloon advanced too far and it was not possible to track it back.Due to this issue, it was determined that the valve could not be implanted at the intended position.The decision was made to deploy the valve in the aorta.During valve deployment, the balloon would not inflate.Blood was observed coming back into the atrion inflation device.Contralateral vessel access with a cross wire was achieved to make sure of perfusion, and that there was no damage to the femoral artery.After unsuccessful attempts to pass the wire through the sapien 3 valve, a snare was simultaneously used to hold the safari wire to retrieve the valve and separate it from the delivery system.Finally, the team was able to open up the valve from the inflow to the outflow.The valve was brought back to the aorta and left there until vascular surgeons were called to convert to open aortic valve replacement (avr).The sapien 3 valve and delivery system were removed from the patient.The patient expired the day after the open avr.The cause of death was not provided.Review of the device photographs provided indicated a liner strand present.The access vessel minimum luminal diameter (mld) measured 9mm.Vessel tortuosity and calcification were reported.

Manufacturer Narrative

Additional information: section h6: evaluation codes; section h10: narrative text.Additional information indicated the patient death was likely related to difficult anatomy and the prolonged time of the avr procedure, the commander delivery system was not returned to edwards lifesciences for evaluation.Without the device, visual inspection, functional testing and dimensional analysis could not be performed.Review of case imagery and photos of the device post procedure revealed the balloon torn at the crimp balloon proximal to the inflation crimp balloon bond.The valve appeared to be partially expanded on the proximal side.A strand of the sheath liner also appeared to be attached to the valve.Cine of the delivery system insertion through the sheath showed valve diving when navigating through the patient¿s tortuous anatomy.The valve was observed exiting the sheath non-coaxially against the flex tip.No cine was provided of actual valve alignment.Valve appears partially on inflation balloon not fully aligned between markers.Flex tip was not supporting the thv.Flex tip was pulled back to triple markers.Evidence of tension buildup via the compressed balloon spring.The valve was not fully aligned between the markers.The flex tip was not supporting the valve ¿ partially pulled away from the valve.The valve appeared to be partially expanded in the proximal end and the flex tip was not supporting the valve.Tortuous access vessels were also observed in the imagery provided.Device history review (dhr) review was performed for the components most relevant to the reported event.The work orders did not reveal any manufacturing non-conformances that could have contributed to the reported event.Lot history review revealed no other similar complaints for the appropriate complaint codes.Complaint history review from may 2019 to april 2020 for the delivery system (all models and sizes) revealed other returned complaints for the appropriate complaint codes.A review of complaint data for april 2020 revealed that the complaint rates did not exceed the control limits for the applicable complaint trend categories.The ifu, device preparation manual, and procedural training manual were reviewed for instructions and guidance on device preparation and/or usage.The operator is instructed to use caution in tortuous or calcified vessels that would prevent safe entry of the introducer set.Additionally, push for can vary due to angle of insertion, thv size, vessel diameter, tortuosity, and degree of calcification.If push force is high, the operator is instructed to slightly pull back the sheath while advancing the delivery system 1-2cm.Delivery system removal: completely unflex the delivery system, ensure the flex tip is still over the triple marker, ensure balloon lock is locked, ensure the balloon is completely deflated, pull the entire delivery system through the sheath, maintain guidewire position in the aorta.Caution: patient injury could occur if the delivery system is not completely unflexed prior to removal.No ifu/training deficiencies were identified.During the manufacturing process the crimp balloon undergoes multiple 100% final inspections.The delivery system components undergo multiple 100% inspections.The delivery system undergoes 100% leak testing followed by inspection of the inflation balloon.During final inspection, distal to proximal visual inspection is performed.Additionally, product verification (pv) testing is performed based on a sampling plan.These inspections during the manufacturing process support that it is unlikely a manufacturing non-conformance contributed to the reported complaint.In this case, the complaints were confirmed based on the imagery/cine provided.However, without the device, the presence of a manufacturing non-conformance was unable to be confirmed.Imagery review showed that valve diving (non-coaxial placement of valve in relation to the flex tip) occurred during insertion through the sheath with severe valve diving observed as the thv exited the sheath.This navigation through the patient¿s tortuous anatomy could have resulted in a build-up of tension in the system later translating to difficulties with valve alignment.Under simulated conditions (simulated tortuous anatomy), a previously performed engineering study was able to recreate high valve alignment forces.Excessive manipulation to overcome tension build-up from navigating tortuous anatomy and valve alignment difficulties could have resulted in damage to the crimp balloon, which likely further exacerbated the situation, making full valve alignment and deployment improbable.Although a definite root cause was not able to be determined, available information suggests procedural factors (tension build-up, excessive device manipulation), in addition to patient factors (vessel tortuosity) may have contributed to the balloon tear during valve deployment and the subsequent open surgery to remove the tavr devices and perform the surgical avr.The prolonged avr procedure,(cardiopulmonary bypass) to implant a non-edwards surgical valve may have contributed to the patient death on pod1.Available information suggests that procedural factors (tension build-up; excessive manipulation) may have contributed to the complaint event.Per management discretion, the balloon torn issue and it associated risks have previously been assessed and documented in a product risk assessment.No ifu/training material deficiencies were identified.A capa was previously initiated to address the balloon torn failure mode.Please reference related manufacturer report no: 2015691-2020-11723.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: EDWARDS COMMANDER DELIVERY SYSTEM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 10011221
• MDR Text Key: 195111522
• Report Number: 2015691-2020-11719
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/07/2020

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: 01/22/2022
• Device Model Number: 9610TF29
• Device Lot Number: 62937596
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/07/2020
• Initial Date FDA Received: 04/29/2020
• Supplement Dates Manufacturer Received: 06/05/2020; 07/23/2020
• Supplement Dates FDA Received: 06/06/2020; 01/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0835-2019
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 85 YR