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

Model Number 9600LDS29A

Device Problems Inadequacy of Device Shape and/or Size (1583); Failure to Align (2522); Material Twisted/Bent (2981); Material Split, Cut or Torn (4008)

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

Event Date 10/18/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation is still ongoing.

Event Description

As reported by edwards engineering department pre-decontamination findings, a twisted shape of the delivery system crimp balloon was observed.Difficulties deflating the balloon may lead to decreased blood flow from the left ventricle (lv) to the remainder of the body, resulting in prolonged hypotension and decreased perfusion to the body.A second valve and delivery system were prepped and deployed with good result.

Manufacturer Narrative

This is one of two manufacturer report being submitted for this case.Please reference related manufacturer report no: 2015691-2021-06522.(mdr# 2021-17971-01).

Manufacturer Narrative

The following report fields have been updated due to additional information received: g3, h6.The edwards commander delivery system was returned for evaluation.The device was visually evaluated, and the following was observed: gouges present on flex tip.Crimp balloon twist observed.Bunching at distal balloon pumpkin observed.A review of the device history record (dhr) did not reveal any manufacturing nonconformance issues that would have contributed to the complaint event.A lot history review was performed and revealed complaints relating to the complaint codes.3mensio imagery provided was evaluated and the following was observed: 3mensio shows calcification and tortuosity in patient aortic anatomy.The instructions for use (ifu)/labeling training were reviewed for the commander delivery system, device preparation manual, and device procedural manual.Per the warnings/precautions: do not mishandle the delivery system or use it if the packaging or any components are not sterile, have been opened or are damaged (e.G., kinked or stretched), or the expiration date has elapsed.Visually inspect all the components for damage.Ensure the delivery system is fully unflexed and the balloon catheter is fully advanced in the flex catheter.To prevent possible damage to the balloon shaft, ensure that the proximal end of the balloon shaft is not subjected to bending.Do not position the thv past the distal valve alignment marker.This will prevent proper thv deployment.No ifu/training deficiencies were identified.A functional test was performed, and the following was observed: during evaluation, engineering performed valve alignment.The balloon shaft was able to pull to warning marker, lock and use full fine adjustment.Resistance was observed during gross alignment and due to the kink on the proximal balloon shaft (likely due to packaging), distal to the warning marker locknut/collet force measurements were taken of the returned device.The locknut/collet engagement tensile strength measurement shows device met specification.After engineering deployed valve, no observed leakage was seen on the delivery system.The crimp balloon was twisted and would untwist clockwise during inflation of the balloon and twist counterclockwise during deflation.Additionally, the returned device was evaluated for balloon inflation/deflation time to simulate thv deployment.The measurements met the specification.Due to the nature of the complaint, no applicable dimensional testing could be performed at this time.During manufacturing, the device was 100% inspected.During the final inspection, the device underwent 100% inspection by both manufacturing and quality.Additionally, all manufacturing lots are subject to product verification (pv) testing on a sampling basis.These inspections and tests performed during the manufacturing process support that it is unlikely that a non-conformance contributed to the reported complaint.A risk assessment was performed on the reported event.There was no evidence of product non-conformances or labeling/ifu inadequacies identified in the evaluation.A product risk assessment escalation is not required.There was no confirmed edwards defect, and no corrective or preventative actions are required.This event reports a twisted crimp balloon during post-procedural product evaluation that has not resulted in a patient harm, or a device failure to perform its function.Also, there was no evidence of product non-conformances or labeling/ifu inadequacies identified in the evaluation.Therefore, it is not included in the risk management file.Edwards continues to monitor complaint history on a monthly basis.Therefore, the review of risk management file is complete, and no further action is required.The complaint for "general risks - failure - balloon incorrect shape" was confirmed based on evaluation of the returned device.A potential manufacturing defect may have contributed to the incorrect balloon shape.The corrective and preventative action which was initiated to drive corrective actions to address issues in manufacturing that can contribute to the complaint event.While the occurrence date of this reported event falls after implementation of corrective actions as documented in the corrective, the occurrence rate did not exceed the trending control limits.The complaint for "navigate and position catheter to target location - valve alignment difficulty or inability - fine adjust" was confirmed based on the condition of device return.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 manufacturing non-conformance would have contributed to the complaint.A review of the ifu and training manuals revealed no deficiencies.Per the complaint description, "there was severe aortic tortuosity and user was unable to properly align the valve between the markers, as a flex catheter was pulled inside the crimped valve after multiple attempts.The operator may have pulled past the warning marker while resetting the alignment wheel multiple times.The difficulty was experienced during fine adjust, so they were unable to fully align the system.The first valve and delivery system were pulled back into the sheath and removed from the body".Per follow-up responses, valve alignment was attempted in non-straight section of aorta.Additionally, 3mensio revealed tortuosity and calcification were present in patient's access vasculature.Performing valve alignment in a tortuous anatomy or in a non-straight section of aorta increases the force required to position the valve between the valve alignment markers.Furthermore, performing valve alignment in a non-straight section of aorta may cause the thv to "dive" into the lumen of the flex tip, as evidenced by the flex tip gouges observed, which can result in additional valve alignment forces.Under simulated conditions (simulated tortuous anatomy), a previously performed engineering study was able to recreate high valve alignment forces (see attachment).During product evaluation of the returned device, engineering observed the twisted crimp balloon.Functional testing showed the device functions within anticipated inflation/deflation time.As per what was identified through product risk assessment and corrective and preventative actions, the twisting of the crimp balloon component can occur during manufacturing, due to inadequate manufacturing procedures and equipment, leading to an incorrect crimp balloon shape on the final device assembly.The complaint for "navigate and position catheter to target location - valve alignment difficulty or inability - fine adjust" was confirmed.No manufacturing non-conformances were identified during the evaluation.A definitive root cause was unable to be determined; however, available information suggests patient factors (tortuosity, calcification) and/or procedural factors (valve alignment in non-straight section) may have contributed to the reported complaint.Since no labeling or ifu/training inadequacies were identified; therefore, corrective/preventive action nor pra is not required.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.

• 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: 12872235
• MDR Text Key: 284970105
• Report Number: 2015691-2021-06522
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/24/2023
• Device Model Number: 9600LDS29A
• Device Lot Number: 63846689
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/03/2021
• Initial Date FDA Received: 11/24/2021
• Supplement Dates Manufacturer Received: 11/24/2021; 01/17/2022
• Supplement Dates FDA Received: 11/25/2021; 01/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2021
• 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 Age: 78 YR
• Patient Sex: Female