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

Model Number 9750CM26A

Device Problems Burst Container or Vessel (1074); Difficult to Remove (1528); Material Separation (1562)

Patient Problem Injury (2348)

Event Date 12/08/2020

Event Type  Injury  

Manufacturer Narrative

Udi number: (b)(4).Edwards lifesciences continues to investigate the reported event and a supplemental report will be submitted in accordance with 21 cfr 803.56 when additional information becomes available.

Event Description

As reported, during a transfemoral tavr procedure, a 26mm sapien 3 ultra valve and commander delivery system were advanced through a 14fr esheath without issue.Valve alignment was performed.The valve was tracked across the arch and crossed the aortic valve.The pusher was pulled back and deployment was started.During deployment, the balloon ruptured as it came into contact with calcium within the stj.The sapien 3 ultra valve was about 90% deployed with mild paravalvular leak (pvl) but stable.During removal of the device, as the delivery system got close to the tip of the sheath, the camera was moved to watch the balloon come back into the sheath.As the system was withdrawn, it caught on the tip of the sheath.The proximal aspect of the balloon entered the sheath,1 but the distal aspect kept getting caught.The decision was made to remove the sheath and delivery system as a unit.The devices were able to be pulled into the iliac artery.It was advised not to pull too hard on the delivery system as the nose cone can become dislodged.The device continued to be withdrawn and as it got to the femoral artery, increased resistance was encountered.As withdrawal efforts continued, a portion of the distal balloon and nose cone became dislodged from the delivery system.The device was still on the wire.The sheath had already been removed from the vessel, so the sheath and delivery system were removed and 16fr non-edwards sheath was inserted.A cutdown was performed to remove the nose cone and balloon material.A non-edwards balloon was used to post dilate the valve.At the time of the report, the patient was in stable condition.The valve remains implanted in the patient.

Manufacturer Narrative

Additional information: section h6: evaluation codes, section h10: narrative text.The commander delivery system was not returned to edwards for evaluation.Without the device, visual inspection, functional testing and dimensional analysis could not be performed.Review of the provided 3mensio imagery revealed calcification present on the st junction and native annulus.Review of the post procedural photographs of the device revealed a balloon burst in longitudinal and radial tear, and the completion of the balloon could not be determined.The distal portion of the balloon and nose tip were separated from the delivery system.Procedural photos indicated the separated nose tip with balloon on the guidewire was removed through the cutdown.Procedural images also showed the balloon burst during inflation and the deployed valve was not fully expanded with a waist.Device history review (dhr) was performed for the components most relevant to the reported event.The work orders did not reveal any manufacturing non-conformances that could have contributed to the reported event.Lot history review revealed one other similar complaint related to the associated codes.Available information suggested patient factors (calcification) may have contributed to the reported event.Complaint history review from january 2020 to december 2020 for the commander delivery system (all models and sizes) revealed other similar complaints for the associated root cause/evaluation codes.No non-conformances were identified during the evaluations.Available information suggested patient factors and procedural factors may have contributed to the reported.Events.Per the instructions for use (ifu) and training manuals, if a balloon burst occurs, attempt to visualize location of tear either in tee or via angio through the pigtail or catheter/delivery system.When removing, ensure the catheter/delivery system and wire are coaxial with the sheath tip.Watch under fluoro with every movement.Be patient and pull gently especially near tear and balloon shoulder transitions.Do not force if resistance is met near or at the sheath tip.Force could result in additional tearing of the balloon material and the balloon material or tip coming off.If getting resistance, going in with a snare and compressing the distal end of the torn balloon to prevent it from ¿umbrella-ing¿ at the tip of the sheath could help.Understanding where the tear is may help in this case.If successful in pulling the entire balloon into the tip of the sheath, withdraw the catheter/delivery system and sheath as a single unit completely from the arteriotomy while maintaining guidewire position.Do not attempt to pull just the catheter/delivery system through the sheath.If you are not able to pull the entire balloon into the sheath, do not attempt to remove the exposed balloon through the vasculature.Risk of major complication is too high.Convert to surgery immediately.It should be surgically removed.Surgeon should be in a position to be able to evaluate the situation before a real bleeding emergency occurs.No ifu/training manual deficiencies were found.During the manufacturing process, the asc4 balloon and crimp balloon undergo multiple 100% visual and dimensional inspections.The crimp balloon undergoes 100% dimensional inspections and 100% visual inspections with an unaided eye and under 8x magnification.The guidewire shaft, balloon catheter laser bond, balloon pleating also undergo visual inspections.During final inspection, the entire device undergoes 100% distal to proximal visual inspection.Additionally, product verification testing based on a sampling plan is performed on each lot prior to release.These inspections during the manufacturing process support that it is unlikely a manufacturing non-conformance contributed to the reported complaint.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.In this case, the complaints were confirmed based on the provided imagery.However, no manufacturing nonconformance was identified during the evaluation.A review of the dhr, lot history, complaint history and manufacturing mitigations did not provide any indication that a manufacturing non-conformance would have contributed to the complaint.As reported, ¿the balloon ruptured as it came into contact with calcium within the stj¿.In addition, noted that patient had calcification present in the annulus.The presence of calcification can create a challenging anatomy for balloon inflation.While the balloons are sufficiently designed and tested for rated burst pressures well above their inflation pressure, calcified nodules can compromise the structure of the balloon wall via following mechanisms such as puncture, local overstretching, open cell impingement, or stress concentration.As reported, ¿as we were withdrawing the system it caught on the tip of the sheath.¿ it is possible that the balloon burst altered the balloon profile.The altered delivery system made the device more susceptible to catching on the tip of the sheath.This subsequently led to the high resistance during withdrawal of delivery system from the patient.And as reported, ¿as we were withdrawing the system it caught on the tip of the sheath.The proximal aspect of the balloon entered the sheath but the distal aspect kept getting caught.We elected to pull the sheath and delivery system as a unit and were able to get both into the iliac.We continued to withdraw and as we got to the femoral the balloon met increased resistance.I advised not to pull to hard on the delivery system as the nose cone can become dislodged.They continued to pull on the system and the portion of the distal balloon and nose cone came dislodged from the delivery system.¿ available information suggests patient factors (calcification) likely contributed to the balloon burst during valve deployment.The altered balloon profile likely made the device more susceptible to catching on the tip of the sheath and contributing to the withdrawal difficulty.Procedural factors (withdrawal of burst balloon/excessive manipulation), likely contributed to the nose tip separation and subsequent surgical removal of the device.Additionally, in this case a femoral artery injury occurred and was possibly due to procedural factors (device manipulation) and/or severe calcification of the access vessel that may have contributed to the complaint event.No ifu/labeling/training manual inadequacies or manufacturing nonconformance were identified.Therefore, no corrective or preventative action, nor product risk assessment is required at this time.

• Brand Name: EDWARDS COMMANDER DELIVERY SYSTEM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 11103363
• MDR Text Key: 226232145
• Report Number: 2015691-2020-15342
• 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,health
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/18/2022
• Device Model Number: 9750CM26A
• Device Lot Number: 63249691
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention