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

Model Number 9600LDS26J

Device Problems Loss of or Failure to Bond (1068); Fluid/Blood Leak (1250)

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

Event Date 12/07/2022

Event Type  malfunction  

Event Description

As reported by our edwards lifesciences japanese affiliate, during the implant of a 26mm sapien 3 valve in the aortic position via trans-subclavian approach, as the delivery system was inserted, significant resistance was observed at the right subclavian artery.The delivery system was advanced carefully while adjusting the angle of the sheath.Fine adjustment difficulty was experienced as well.After crossing the delivery system into the aortic valve, the flex catheter was pulled back, and the sapien 3 valve moved towards the aorta.Valve alignment was performed again, and the flex catheter was pulled back.There was an attempt to deploy the sapien 3 valve, but the balloon did not inflate, and contrast agent leaked from the delivery system.The delivery system was withdrawn into the esheath.A second kit was opened, and the second valve was deployed without issue.The patient was described as 'well' after the procedure, and no injury to the patient was reported.

Manufacturer Narrative

Investigation is ongoing.The device was discarded.

Manufacturer Narrative

A supplemental mdr is being submitted for correction and additional information based on the device evaluation.The following sections of this report have been updated: h.6 device code(s), h.6 type of investigation, investigation findings, h.6 investigation conclusions, h.6 component code.The commander delivery system was not returned to edwards lifesciences for evaluation.Without the device returned for evaluation, visual inspection, functional testing and dimensional analysis were unable to be completed.Imagery was provided from the site and revealed the following: the patient's access vessel (right subclavian) was tortuous, calcified, and undersized (less than 6.0 mm).The crimp balloon was torn at the i/c bond and the balloon wings were exposed.Separation of the crimp balloon proximal to the i/c bond during valve alignment of the delivery system is an issue that has been previously identified and investigated in a product risk assessment (pra).Manufacturing mitigations/controls relevant to the issue are captured in the pra.The content was reviewed and remains applicable to the manufacturing of released work orders prior to the complaint occurrence date.Additionally, the work order underwent product verification testing as a requirement for lot release.Five (5) lot samples were taken for testing.These inspections and tests during the manufacturing process support that it is unlikely that a non-conformance contributed to the reported complaint.A device history record review (dhr) was performed and did not reveal any manufacturing nonconformance that would have contributed to this complaint event.A review of the lot history revealed no other similar returned complaints for the trend categories.The instructions for use/training manuals were reviewed for guidance/instruction involving the commander delivery system usage.Based on the review of the ifu/training manuals, no deficiencies were identified.A review of the risk management documentation was performed, and 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.Potential root causes for separation of the inflation balloon to crimp balloon bond have been identified and documented in a pra.As identified in the pra, high forces on the system during valve alignment may result in crimp balloon tearing prior to thv deployment.As difficulty performing valve alignment was reported, it is possible that increased forces of performing valve alignment may have weakened the balloon and caused the balloon to tear and subsequent inability to deploy the thv.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 valve alignment forces) may have contributed to the reported event.The ifu and training manuals have been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.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.A pra was previously initiated to investigate the cause and assess the risks associated with a torn balloon.Corrective action was previously initiated to address this issue.While this event occurred post implementation of corrective actions, the occurrence rate did not exceed the december 2022 trending control limits or the existing risk management occurrence rate.Therefore, no further action is required at this time.

• 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 CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 16045491
• MDR Text Key: 306246965
• Report Number: 2015691-2022-10347
• 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: 02/10/2023

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: 06/15/2024
• Device Model Number: 9600LDS26J
• Device Lot Number: 64407538
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/07/2022
• Initial Date FDA Received: 12/23/2022
• Supplement Dates Manufacturer Received: 02/08/2023
• Supplement Dates FDA Received: 02/10/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/17/2022
• 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: 84 YR
• Patient Sex: Male