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

Model Number 9610TF29

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 11/09/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation is ongoing.

Event Description

As reported by the edwards european affiliate, during a tf mitral valve replacement case there was difficulty aligning the valve within a straight section of the aorta, requiring more strength than usual during fine adjustment.It was not possible to inflate the balloon at the time of deployment.The delivery system with the crimped valve and esheath were removed as one unit.The patient did not suffer any injury.It was decided to use a second kit.The 2nd valve was successfully implanted and the final outcome of the patient was satisfactory.

Manufacturer Narrative

Added h.6 type of investigations and investigation findings.Corrected h.6 investigation conclusions.The device was not returned for evaluation.A dhr review was performed and did not reveal any manufacturing nonconformance issues that would have contributed to the complaint event.A review of lot history revealed no other events related to valve alignment difficulty and torn balloons.During manufacturing of the commander delivery system, the delivery system and components are inspected several times throughout the manufacturing process.In addition, product verification testing was performed on a sampling basis and all testing met specifications.These inspections performed during manufacturing process and testing performed during product verification support that it is unlikely that a manufacturing non-conformance contributed to the reported events.Imagery was provided from the site and the inflation balloon to crimp balloon was observed to be torn with wings flared outward.Inflation balloon material bunching was noted towards the distal end.No abnormalities were seen on the valve.The ifu, device preparation manual, and procedural training manual were reviewed.During valve alignment, unlock, pull the balloon catheter straight back at the y-connector until part of the warning marker is visible and lock.Do not bend or apply torque to the proximal end of the balloon catheter throughout the procedure.Rotate the balloon lock away from you to lock and towards you to unlock.Lock/unlock symbols are found on the balloon lock.Check delivery system before valve alignment.If kinked, do not use.Manage guidewire position.Guidewire can move proximally during valve alignment.The warning marker indicates the balloon catheter is approaching a hard stop.Do not pull past the warning marker.Maintain guidewire position in the left ventricle during valve alignment.Re-lock the device after unlocking every time.Slowly rotate the fine adjustment wheel towards you to center the thv exactly between the valve alignment markers with no gap or overlap.Fine adjustment indicator shows how much fine adjustment is left.If additional fine adjustment is needed, unlock and rotate the fine adjustment wheel away from you until part of the warning marker is visible and relock.A gap between the thv and distal valve alignment marker may result in difficulty crossing.An overlap cannot be reversed and may prevent proper thv deployment.Fine adjustment wheel functions only when the balloon lock is locked.Do not bend or apply torque to the proximal end of the balloon catheter throughout the procedure.Do not position the thv past the distal valve alignment marker.This will prevent proper thv deployment.Compression may be observed in the distal portion of the flex catheter during valve alignment.Diving may be observed between the thv and the flex catheter tip during valve alignment.To correct: 1.Move to a different straight section of the aorta (for diving only).2.If using the balloon catheter, push forward slightly, and then continue pulling back until part of warning marker is visible.3.If using the fine adjustment wheel, reverse and then continue with fine adjustment until thv is centered exactly between the valve alignment markers.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.Utilizing alternate fluoroscopic views may help with assessing curvature of the anatomy.If excessive tension is experienced during valve alignment, repositioning the delivery system to a different straight section of the aorta and relieving compression (or tension) in the system will be necessary.No ifu or training deficiencies were identified.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 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.Since no product non-conformances or ifu/training deficiencies were identified during evaluation, a product risk assessment escalation is not required.As there was no confirmed edwards defect, no corrective/preventative actions are required.The torn balloon and difficulty with valve alignment were confirmed.As the device was not returned, engineering was unable to perform any visual inspection, functional testing, or dimensional analysis.Therefore, the presence of a manufacturing non-conformance was unable to be determined.A review of the dhr, lot history, manufacturing mitigations and complaint history did not provide any indication that a manufacturing non-conformance would have contributed to the complaints.A review of ifu/training materials revealed no deficiencies.As reported, 'during procedure, it was found some difficulties while valve alignment at a straight section of the native cave.It was needed to apply more strength than usual while fine adjustment.It was not possible to inflate the balloon, and therefore to expand the valve'.Imaging evaluation revealed inflation balloon material bunching at the distal end of the valve.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, it is possible that the balloon profile may be 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 observed in the system.Per the training manual, 'if excessive tension is experienced during valve alignment, repositioning the delivery system to a different straight section of the aorta and relieving compression (or tension) in the system will be necessary.' it is possible that once the resistance was felt, 'more strength than usual' was applied to overcome the resistance.It is possible that increased forces and tension could have then weakened the balloon causing the balloon to tear.A definitive root cause was unable to be determined at this time.However, available information suggests procedural factors (residual fluid, altered balloon profile, high alignment forces, excessive manipulation) may have contributed to the reported events.

• Brand Name: EDWARDS 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: 12895033
• MDR Text Key: 281418278
• Report Number: 2015691-2021-06591
• Device Sequence Number: 1
• Product Code: NPU
• UDI-Device Identifier: 00690103193008
• UDI-Public: (01)00690103193008(17)230901(10)63971397
• 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: 01/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2023
• Device Model Number: 9610TF29
• Device Lot Number: 63971397
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2021
• 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