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

Model Number 9610TF26U

Device Problems Fluid/Blood Leak (1250); Positioning Problem (3009); Material Split, Cut or Torn (4008)

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

Event Date 08/16/2022

Event Type  malfunction  

Event Description

As reported by an edwards (b)(4) affiliate, during a transfemoral tmvr valve in valve (vinv) procedure with a 26mm sapien 3 ultra valve into a non-edwards surgical valve, during deployment, the balloon did not inflate, so it was decided to use a new system.Upon removal of the devices, it was noticed that the balloon had come completely away from the catheter.A new system was prepped and the valve was successfully implanted.As per medical opinion, it is thought that the open cells damaged the balloon as team made several attempts to position the valve on the balloon.

Manufacturer Narrative

Investigation is still ongoing.

Manufacturer Narrative

Correction to h6 based on additional information.The device was returned to edwards lifesciences for evaluation.Visual inspection was performed, and the following was observed: the thv was crimped over the inflation balloon, with bunching of the distal portion of the balloon, balloon tear at the inflation/crimp balloon bond, with wings exposed, and liner stretching observed on sheath distal end.No other abnormalities were noted.Functional testing was performed on the delivery system and the following was observed: fine adjustment was able to be performed successfully without issue, and gross alignment was able to be performed successfully without issue.Dimensional testing was performed and the following was observed: double-wall thickness measurements of the crimp balloon were taken, and measured components were within specifications.Imagery was provided by the field and the following was observed: thv crimped partially over inflation balloon working length, bunching of the distal working length, and withdrawn incompletely through sheath tip.A device history record (dhr) review did not reveal any manufacturing nonconformance issues that would have contributed to the event.A lot history review was performed and revealed no other complaints relating to the reported event were identified.The instructions for use/training manuals were reviewed for guidance/instruction involving the esheath and delivery system usage.Based on the review of the ifu/training manuals, no deficiencies were identified.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 complaint for balloon torn was confirmed based on evaluation of the returned device.However, the complaints for valve alignment difficulty and delivery system difficult to cross septal wall were unable to be confirmed as the complaint was unable to be replicated with the devices returned, and no applicable procedural imagery was provided for evaluation.As reported, 'as per medical opinion, it is thought that the open cells damaged the balloon as team made several attempts to position the valve on the balloon.' as evaluation of the returned device revealed no device defect (able to perform gross alignment and utilize full fine adjust), it is possible that tension was introduced onto the delivery system and resulted in the reported 'several attempts' to align the valve.The exact cause of tension is unknown, however, is it is possible that 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 valve alignment 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.In addition, while bunching of the distal inflation balloon was observed on the returned device, this can be attributed to withdrawal of the device and instead of valve alignment difficulty.Observations of the returned sheath show stretching of the distal liner, suggesting the bunching may have occurred during withdrawal.However, without applicable patient/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) may have contributed to the complaint event.As reported, 'when the valve was retrieved from patient, it was noticed that the balloon had come completely away from the catheter.' evaluation of the returned complaint device revealed a torn i/c bond.Potential root causes for separation of the inflation balloon to crimp balloon bond have been identified and documented in a previously initiated product risk assessment.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) may have contributed to the reported event.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.No corrective or preventative actions are required.

Manufacturer Narrative

Correction to h6 based on additional information.

• Brand Name: COMMANDER DELIVERY SYSTEM
• Type of Device: PROSTHESIS, MITRAL VALVE, 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: 15396723
• MDR Text Key: 301494109
• Report Number: 2015691-2022-07817
• Device Sequence Number: 1
• Product Code: NPU
• 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,Followup
• Report Date: 11/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2023
• Device Model Number: 9610TF26U
• Device Lot Number: 64145182
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2021
• 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: 88 YR
• Patient Sex: Male