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

Model Number 9600LDS29J

Device Problems Difficult or Delayed Positioning (1157); Difficult to Remove (1528); Deformation Due to Compressive Stress (2889)

Patient Problems Unspecified Vascular Problem (4441); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/07/2021

Event Type  Injury  

Manufacturer Narrative

Investigation is still ongoing.

Event Description

During a transfemoral transcatheter aortic valve replacement (tavr) for the native aortic position, insertion difficulty in a 16 fr esheath, valve diving, alignment difficulty, deformation of a 29mm commander delivery system, and withdrawal difficulty were reported.Since the valve could not be pulled back into the sheath, both devices were withdrawn together.However, the operator forcibly pulled the catheter to get the valve into the sheath, the sheath got bent and all devices were stuck in the body.The devices were cut in the middle to pull out them, but distal side of the delivery system including the valve was left inside the body.They were surgically removed.Another device was used, and a 29 mm sapien 3 valve was deployed without problem.On postoperative day 11 or 12, the patient expired due to asphyxia.

Manufacturer Narrative

The edwards commander delivery system was returned for evaluation.A device history record (dhr) review did not reveal any manufacturing nonconformance issues that would have contributed to the complaint event.A lot history review was performed and did not reveal any complaints relating to the complaint codes.As the returned device meets specification with no evidence to support a manufacturing/design defect has contributed to the complaint, a manufacturing mitigation review is not required.The flex shaft was 100% visually inspected and rejected for physical damage (kink, crack, gouge, puncture), raised edges/material, exposed metal on stent section, or liner delamination at inner diameter of distal end of flex shaft.These inspections and tests during the manufacturing process support that it is unlikely that a non-conformance contributed to the reported complaint.Separation of the crimp balloon proximal to the i/c bond during withdrawal of the delivery system is an issue that has been previously identified and investigated in product risk assessment.Manufacturing mitigations/controls relevant to the issue are captured in pra.Valve alignment was performed on the returned device (without distal balloon shaft and distal flex shaft).Gross alignment was performed with no issues.The balloon lock was able to be locked and unlock.Fine adjust was able to be performed with no issues.The inflation balloon was cut at the guidewire lumen with i/c bond separated, returned with balloon wing flared outward and appears wrinkled.The distal sheath liner was partially delaminated and bunched.Double wall thickness of the crimp balloon was taken.An out of specification measurement could make the material more susceptible to tearing and be indicative of a manufacturing non-conformance.No imagery was provided.The labeling/instructions for use (ifu) for commander delivery system, device preparation manual, and device procedural manual were reviewed.Per contraindications and prohibitions, do not use this device in patients who have the following: iilio-femoral artery with severe obstructive calcification or severe tortuosity that could prevent safe placement of the sheath.Per caution, to prevent possible damage to the balloon shaft, ensure that the proximal end of the balloon shaft is not subjected to bending.Ensure there is no residual contrast medium left in the balloon to avoid potential difficulty with valve alignment during the procedure.The physician must verify correct orientation of the thv prior to its implantation; the inflow (outer sealing skirt) of the thv should be oriented distally towards the tapered tip.The complaints for "navigate and position catheter to target location - valve alignment difficulty or inability - gross alignment" and "general risks - failure - flex shaft cracked/damaged" were unable to be confirmed based on the condition of the returned device and unavailability of the distal flex shaft.The complaint for "withdraw catheter and valve through vasculature / sheath - difficulty or inability to withdraw system with valve through sheath" & "general risk - failure - balloon torn" was confirmed based on the condition of the returned device.However, no manufacturing nonconformance was identified during the evaluation.A review of the dhr, complaint history review, lot history, and manufacturing mitigations 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.As reported, "the operator decided to do valve alignment near the aortic arch where the vessel was curved.Compression and valve diving were observed on the delivery system, and it was unable to place the valve between the alignment markers by several attempts.Flex shaft became deformed further." tension present in the system during valve alignment may result in higher forces necessary to align the valve, contributing to the reported valve alignment difficulty and deformed/compressed distal flex shaft.Tension in the system may be induced by patient and procedural factors such as tortuosity and performing valve alignment in a non-straight section (near the aortic arch).If there is tortuosity present in the vasculature, it may be difficult to pull the balloon shaft through the flex shaft along bends in the anatomy.Under simulated conditions (simulated tortuous anatomy), a previously performed engineering study was able to recreate high valve alignment forces.Furthermore, if the thv alignment is performed at an angle (non-straight section of aorta), this can cause the thv to unseat from the flex tip (non-coaxial placement of valve in relation to the flex tip) during alignment and "dive" into the lumen of the flex tip.If the thv is unseated during alignment, it can result in additional valve alignment forces.Per the training manual, "if excessive tension is experienced during valve alignment, repositioning the delivery system to a different straight section of the aorta and relieving compression (or tension) in the system will be necessary." the complaint for "navigate and position catheter to target location - valve alignment difficulty or inability - gross alignment" was unable to be confirmed.However, no manufacturing non-conformances were identified during evaluation.Available information suggests patient (tortuosity) and procedural factors (valve alignment performed in non-straight section) contributed to the reported event.The complaint for "general risks - failure - flex shaft cracked/damaged" was unable to be confirmed.However, no manufacturing non-conformances were identified during evaluation.Available information suggests patient (tortuosity) and procedural factors (valve alignment performed in non-straight section) contributed to the reported event.No ifu/labeling/training manual inadequacies were identified.The complaint for "withdraw catheter and valve through vasculature / sheath - difficulty or inability to withdraw system with valve through sheath" was confirmed.However, no manufacturing non-conformances were identified during evaluation.Available information suggests patient (calcification/tortuosity) and procedural factors (non-coaxial withdrawal/withdrawal of crimped valve) contributed to the reported event.The complaint for "general risks - failure - balloon torn" was confirmed.However, no manufacturing non-conformances were identified during evaluation.Available information suggests patient (tortuosity) and procedural factors (valve alignment in non-straight section) contributed to the reported event.No labeling, training, or ifu deficiencies were identified.Therefore, no corrective and preventative action (capa) nor product risk assessment (pra) is required at this time.However, per management discretion, the balloon torn issue and it associated risks have previously been assessed and documented in a pra and capa.As reported, "the valve could not be pulled back into the sheath." the patient was noted to have mild calcification and tortuosity of the access vessel.This may contribute to a non-coaxial withdrawal of the delivery system into the sheath.In this configuration, the valve can catch on the sheath distal tip and prevent any further withdrawal.Additionally, because the delivery system was withdrawn after valve alignment, the outer diameter of the crimped valve on the inflation balloon is larger than that of the crimped valve on the crimp balloon, which can further contribute to withdrawal difficulty.Available information suggests patient (calcification/tortuosity) and procedural factors (non-coaxial withdrawal/withdrawal of crimped valve) contributed to the reported event.Potential root causes for material separation between the inflation balloon and crimp balloon have been identified and documented.It is unknown when the crimp balloon tear occurred.However, as identified in a pra, high forces on the system from the presence of tortuosity during valve alignment or during withdrawal, may result in crimp balloon tearing prior to thv deployment or successful withdrawal of delivery system.As a result, additional manipulation and/or increased withdrawal forces can lead to the separation of the i/c bond.Available information suggests that patient (tortuosity) and procedural factors (valve alignment in a non-straight section) may have contributed to the complaint events.However, a definitive root cause was unable to be determined.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.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.In this case, there was no allegation or indication a device malfunction contributed to this adverse event.A cause for the valve alignment difficulty cannot be determined, however, it may be due to patient (tortuosity) and procedural factors (valve alignment performed in non-straight section).In this case, the cause of the difficulty or inability to withdraw system through the sheath was confirmed.Available information suggests patient (calcification/tortuosity) and procedural factors (non-coaxial withdrawal/withdrawal of crimped valve) contributed to the reported event.In this case, there was no allegation or indication a device malfunction contributed to this adverse event.Investigation results indicate the cause of the torn balloon was confirmed.However, no manufacturing non-conformances were identified during evaluation.Available information suggests patient (tortuosity) and procedural factors (valve alignment in non-straight section) may have contributed to the event.In this case, the reported unspecified vascular injury requiring a surgical cutdown was likely caused by device manipulation during withdrawal of the devices and/or patient factors may have contributed to the complaint event (access vessels with observable calcification and tortuosity).

• 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
• 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: 13083630
• MDR Text Key: 283234634
• Report Number: 2015691-2021-07063
• 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: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2022
• Device Model Number: 9600LDS29J
• Device Lot Number: 63382083
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/07/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/01/2020
• 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): Required Intervention
• Patient Age: 83 YR
• Patient Sex: Male