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

Model Number 9600LDS26J

Device Problems Fracture (1260); Difficult to Remove (1528); Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/03/2022

Event Type  Injury  

Manufacturer Narrative

Investigation is still ongoing.Device was discarded at facility.

Event Description

As reported by an edwards lifesciences affiliate in (b)(6), during a trans subclavian transcatheter aortic valve replacement (tavr) procedure with a 26mm sapien 3 valve, there was valve alignment, fine adjust difficulty, and delivery system balloon leakage that occurred.The fine adjustment wheel was revered back, and resistance was stronger than before.Valve alignment was not completed.When the delivery system balloon was deflated, backflow of blood was confirmed.After device removal, the valve could not be pulled back into the non-edwards sheath.The esheath became stuck and strong resistance at tortuosity of distal carotid bifurcation was encountered.The devices were removed surgically to prevent vascular injury.

Manufacturer Narrative

The device was not returned for evaluation as it was discarded.Therefore, a no product return engineering evaluation was performed.Imagery provided was evaluated, and the following was observed: delivery system observed bending significantly with thv aligned between alignment markers.Valve diving observed.Inflation balloon torn at crimp balloon bond with guidewire lumen cut by nipper.Inflation balloon material bunching distally from thv inflow side.Proximal wings of inflation balloon observed flared out.Significant bend in the patients right subclavian artery.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 valve alignment difficulty, balloon torn, and withdrawal difficulty through non-edwards sheath were confirmed based on evaluation of the provided imagery.Due to the unavailability of the device, engineering was unable to perform any visual, functional, or dimensional analysis.Therefore, a manufacturing non-conformance was unable to be determined during the evaluation.Additionally, a review of the dhr, 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.Per the event description, ''during the alignment, the shaft was not pulled in as much as fine adjustment wheel was turned.The fine adjustment wheel was revered back.Alignment was re-challenged, but resistance was stronger than before, and the alignment was incomplete''.Per imagery review, the patient had tortuosity in access vessel with a significant bend in the subclavian artery.It is possible that tension may have been introduced onto the system leading to the reported valve alignment difficulties.The exact cause of tension is unknown; however, possible sources are a tortuous anatomy or altered balloon profile affected by device preparation steps, such as inflating the balloon past the recommended 20-30% as instructed in ifu materials or leaving residual fluid in the balloon after de-airing.Attempts to align valve over inflation balloon in these conditions can lead to the valve catching onto balloon material and contributing to the valve alignment difficulties reported.Although valve alignment was reported to be performed in a straight section, if valve alignment was performed in a tortuous (non-straight section) vasculature, this can cause 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 is unseated from the flex tip during alignment, it can result in higher-than-normal alignment forces creating high tension in the system which can consequentially lead to the reported fine adjustment difficulties.Under simulated conditions (simulated tortuous anatomy), a previously performed engineering study was able to recreate high valve alignment forces.The study revealed that performing valve alignment in a curvature appears to increase the possibility of 'diving' (thv become unseated from the flex tip), which in turn increases valve alignment force.Higher alignment force appeared to have a higher likelihood of occurrence at tighter radii.However, without applicable procedural imagery, a definitive root cause is unable to be determined.Available information suggests that patient (tortuosity) and/or procedural factors (valve alignment in non-straight section, high alignment forces) may have contributed to the reported event.No ifu/labeling/training manual inadequacies were identified.Therefore, no corrective or preventative action nor product risk assessment (pra) is required at this time per the complaint description, ''to check if balloon rupture by excessive tension to the device and valve alignment occurred, when it was deflated, backflow of blood was confirmed.Balloon rupture was suspected''.Per imagery review, inflation/crimp balloon material separation observed with inflation balloon material bunching distally from thv inflow side potential root causes for material separation between the inflation balloon and crimp balloon have been identified and documented in a pra.As identified in the pra, high forces on the system from the presence of tortuosity during valve alignment, may result in crimp balloon tearing prior to thv deployment.As a result, additional manipulation and/or increased withdrawal forces can lead to the separation of the i/c bond.It is possible that the valve alignment was performed in a non-straight section.Performing valve alignment in a non-straight section can make the valve become unseated (non-coaxial placement of valve in relation to the flex tip) from the flex tip and dive into the lumen of flex tip.It is possible that increased forces and tension could have then weakened the balloon causing the balloon to tear.Available information suggests that patient (tortuosity) and/or 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.No labeling, training, or ifu deficiencies were identified.Therefore, no corrective and preventative action nor pra is required at this time.However, per management discretion, the balloon torn issue and its associated risks have previously been assessed and documented in a pra and a capa was previously initiated to address this failure mode.Per the complaint description, ''device removal was decided.However, the valve could not be pulled back into the sheath.When the delivery system without storing in the sheath was pulled back, getting stuck and strong resistance at tortuosity of distal carotid bifurcation was encountered obviously.Vascular injury was expected, device removal surgically was decided''.Per imagery review, proximal wings of inflation balloon were flared out.Due to the balloon tear, the balloon profile may have been altered during valve alignment.It is possible the balloon tear caused the balloon wings to be exposed and made the device more susceptible to catching on the tip of the sheath.Additionally, a non-edwards sheath was used which may have not been compatible for system retrieval with a crimped valve.A definite root cause was unable to be determined at this time.However, available information suggests patient (tortuosity) and procedural factors (non-coaxial withdrawal, withdrawal torn balloon, use of non-edwards sheath) contributed to the reported event.No ifu/labeling/training manual inadequacies were identified.Therefore, no corrective or preventative action nor pra is 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.

• 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: 13920956
• MDR Text Key: 291726574
• Report Number: 2015691-2022-04664
• 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: 04/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/27/2023
• Device Model Number: 9600LDS26J
• Device Lot Number: 64009550
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2021
• 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: Female