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

Model Number 9610TF29

Device Problem Loss of or Failure to Bond (1068)

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

Event Date 04/26/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation is ongoing.

Event Description

As reported from our affiliates in the (b)(6), this was a case of a 29mm sapien 3 transcatheter heart valve in aortic position by transfemoral approach.The case proceeded as normal.No significant push force was experienced, valve alignment was performed in a straight section and no extra tension was perceived at any point.When it came to deploying the valve, the commander delivery system balloon did not inflate when the inflator was pushed.Therefore, the valve was withdrawn back into the esheath and all devices were removed as a unit.Another system and valve were prepared and deployed with a good result.No injury occurred.When the removed commander delivery system was checked, a complete circumferential tear on the balloon shaft, at about the level of the most distal radio-opaque marker, was found.

Manufacturer Narrative

The device was not returned for evaluation.The imagery provided by site was reviewed and the following was observed: the crimp balloon was torn.The wings were partially exposed.The sheath liner was bunched up.The complaint for balloon torn was confirmed based returned imagery.Due to the unavailability of the device, engineering was unable to perform any visual, functional, or dimensional analysis.A review of 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 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.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.Potential root causes for material separation between the inflation balloon and crimp balloon have been identified and documented in a product risk assessment (pra).As identified in the pra, high forces on the system during valve alignment may result in crimp balloon tearing prior to thv deployment.Potential sources of increased valve alignment forces could be residual fluid in the balloon, patient tortuosity, and performing valve alignment in a non-straight section.The complaint description states, "when it came to deploying the valve, the commander delivery system balloon did not inflate when the inflator was pushed." the case notes revealed that the patient had "mild femoral tortuosity and calcification." if the patient anatomy was calcified and tortuous, it is likely that valve alignment was performed in a non-straight section.Performing valve alignment in a non-straight section can unseat the valve (non-coaxial placement of valve in relation to the flex tip) from the flex tip and dive into the lumen of flex tip.A non-coaxial valve can result in high valve alignment forces.The bond area between the inflation and crimp balloon may separate when subjected to unusually high forces.As per the training manual, "if valve alignment is not performed in a straight section, there may be difficulties performing this step which may lead to delivery system damage and inability to inflate the balloon." it is possible that increased forces and tension could have then weakened the balloon, causing the crimp balloon to tear.Although a definitive root cause is unable to be definitively determined, available information provided from the complaint description and pra suggests that potential patient factors (calcification, tortuosity) may have contributed to the complaint events.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.No corrective or preventative actions are required.

• Brand Name: EDWARDS COMMANDER DELIVERY SYSTEM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 14417630
• MDR Text Key: 291851769
• Report Number: 2015691-2022-05728
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/02/2023
• Device Model Number: 9610TF29
• Device Catalogue Number: N/A
• Device Lot Number: 64073095
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/24/2022
• Date Device Manufactured: 11/02/2021
• 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: 84 YR
• Patient Sex: Male