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

Model Number 9610TF29

Device Problems Break (1069); Material Puncture/Hole (1504); Difficult to Remove (1528); Failure to Align (2522); Material Split, Cut or Torn (4008)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/11/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.This report is 1 of 3 being submitted for this complaint.Reference mfg.Report numbers 2015691-2021-01653 and 20215691-2021-01654.

Event Description

The device was returned and per engineering observation, the crimp balloon was torn.As reported by (b)(6) affiliate, during implant of a 29mm sapien 3 valve, in the aortic position, by transfemoral approach.The valve alignment was not possible done properly due to the anatomy of aorta and the difficulty during the gross and fine adjustment.Frame damage of the valve was noted, and a decision was made to retrieve the valve into esheath and remove it as a single unit.The esheath had a liner tear and puncture.The patient is stable.There was no injury reported.A new valve was implanted without issue.The returned devices showed the commander delivery system had a crimp balloon tear.

Manufacturer Narrative

The 29mm commander delivery system was returned to edwards for evaluation.Upon visual inspection, the following was observed: the valve was crimped on the proximal shoulder of the inflation balloon, bent valve strut observed on the outflow, crimp balloon tore at inflation to crimp (i/c) bond, proximal balloon wings flared, deep flex tip gouges, and three (3) areas of compression near the flex tip.Functional testing was performed, and full valve alignment was able to be performed with no issues.Dimension testing was performed on the double-wall thickness of the crimp balloon and the measured components were within specification.During the manufacturing process, visual inspections and tests are performed throughout the process.In this case, there is no evidence to support a manufacturing design defect potentially contributed to the complaint.A device history record (dhr) review was performed and did not reveal any manufacturing non-conformances that would have contributed to the complaint event.A lot of history record review was performed and did not reveal any related complaints.The ifu for edwards commander delivery system, the device preparation manual, and the procedural training manual was reviewed.The procedural training manual provides guidance on 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, make sure and maintain guidewire position in the left ventricle during valve alignment, 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 and if an 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.Note the following: 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 and do not position the thv past the distal valve alignment marker.This will prevent proper thv deployment.Additional considerations should be noted: compression may be observed in the distal portion of the flex catheter during valve alignment, and diving may be observed between the thv and the flex catheter tip during valve alignment.To correct: move to a different straight section of the aorta (for diving only), oi using the balloon catheter, push forward slightly, and then continue pulling back until part of warning marker is visible and if using the fine adjustment wheel, reverse and then continue with fine adjustment until thv is centered exactly between the valve alignment markers.The thv moves in only one direction relative to the balloon.In addition, 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.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 complaints for valve alignment difficulty or inability, failure balloon torn, and withdraw catheter and valve through vasculature/sheath - difficulty or inability to withdraw system with a valve through sheath were confirmed based on the condition of the returned device.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 a manufacturing non-conformance would have contributed to the complaint.A review of the ifu and training manuals revealed no deficiencies.Potential root causes for separation of the inflation balloon to crimp balloon bond have been identified and documented in a product risk assessments (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 high forces, which will also impact difficulty with aligning the valve, include performing valve alignment in tortuous vasculature.Tortuosity in the descending aorta and difficulty performing valve alignment in a straight section of the aorta were noted in the cer.Performing valve alignment in a non-straight section of the vessel can cause valve diving (thv becomes unseated from the flex tip), as evidenced by the flex tip gouges and compression observed near the flex tip.If the thv is unseated during alignment, the valve can become non-coaxial and can result in high valve alignment forces thus increasing difficulty with valve alignment, difficulty with fine adjust.The accumulated high alignment force can result in an increased tension within the system which can subsequently weaken the inflation balloon to crimp balloon bond causing it to tear.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.From the imagery provided and visual inspection, the crimped valve on the balloon was unable to be withdrawn into the sheath, and the sheath liner was circumferentially delaminated.It is possible the delivery system profile was enlarged due to the balloon tear, and the additional pull force used to withdraw the delivery system, as a result, caused the balloon wings to be exposed and flare outwards, making the device more susceptible to catching on the tip of the sheath.Additionally, the presence of tortuosity may have contributed to the non-coaxial withdrawal of the delivery system into the sheath, making the device more susceptible to catching on the sheath tip.In this case, available information suggests patient (tortuous aorta) and procedural factors (valve alignment in a non-straight section of the anatomy/withdrawal of torn balloon/non-coaxial withdrawal) may have contributed to the reported event.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 ifu/labeling/training manual inadequacies were identified.No corrective or preventative action nor product risk assessment is required for valve alignment or inability, or to withdraw catheter and valve through vasculature sheath difficulty or inability to withdrawal system with a valve through the sheath.The balloon torn issue and its associated risks have previously been assessed and documented in a product risk assessment and capa to address this failure mode.

• Brand Name: EDWARDS COMMANDER DELIVERY
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 11579067
• MDR Text Key: 244656837
• Report Number: 2015691-2021-02109
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/17/2021

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: 08/11/2022
• Device Model Number: 9610TF29
• Device Lot Number: 63357910
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/03/2021
• Initial Date FDA Received: 03/27/2021
• Supplement Dates Manufacturer Received: 05/15/2021
• Supplement Dates FDA Received: 05/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1