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

Model Number COMMANDER DELIVERY SYSTEM UNKNOWN

Device Problems Burst Container or Vessel (1074); Difficult to Remove (1528); Detachment of Device or Device Component (2907); Separation Problem (4043)

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

Event Date 04/27/2021

Event Type  Injury  

Manufacturer Narrative

The investigation is ongoing.

Event Description

As reported by a field clinical specialist, during the procedure of a 29 mm sapien 3 valve in the aortic position via transfemoral approach the balloon ruptured upon deployment of the valve.It appears calcium at the stj caused the rupture.The tear was transverse making it difficult to retrieve the balloon.The balloon would not enter the sheath and would not enter the common iliac.A surgical cutdown was performed on both the right groin and left subclavian to allow for retrieval.The balloon nose cone was snared from the l subclavian and was pulled out.The proximal portion of the balloon catheter and balloon was pulled out through the right groin.The patient tolerated the procedure well and is recovering in the cvu.

Manufacturer Narrative

A supplemental mdr is being submitted for correction and additional information base on the device evaluation.The following sections of this report have been updated: corrected h.3 and h.6 device code, investigation findings and investigation conclusions and added new information to h.6 type of investigation.The 29mm commander delivery system was returned unlocked at packaging position, fully inserted through sheath, loader cap flex shaft, no fine adjustment and no flex used.The returned device was visually inspected and the following was observed: the inflation balloon returned attached to delivery system and full of blood.Balloon cut and separated from delivery system.Radial burst no missing pieces imagery was provided by the site and revealed the following: balloon burst radial.Distal part of the balloon and nose tip separated from the delivery system.Calcification present in annulus and leaflets vessels.Calcification/tortuosity present on the patient access vessels.All inspections are conducted on 100% of units, except in the case of product verification (pv) testing, where the tested units are chosen on a sampling basis.These inspections and tests during the manufacturing process support that it is unlikely that a non-conformance contributed to the reported complaint.A device history record review (dhr) was performed and did not reveal any manufacturing nonconformance that would have contributed to this complaint event.A review of the lot history is not required.The instructions were reviewed instruction for use (ifu) for commander delivery system with s3u, device preparation manual, device training manual and no ifu/training deficiencies were identified.The procedural training manual provides guidance on balloon burst.If the delivery system balloon bursts or leaks during deployment without thv embolization, do not use excessive force, take care when crossing the thv, tracking back over the arch and removing the delivery system (through the tip of the sheath), maintain guidewire position, check for pv leaks under echo and if post-dilation needed, use a new delivery system and sheath.Take care when crossing the deployed valve to prevent potential embolization.Additional guidance for balloon burst.If a balloon burst is suspected, do not attempt to pull back the delivery system into the sheath until you are prepared to conduct the following steps: 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 and 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 successful in pulling the entire balloon and delivery system tip into the tip of the sheath, withdraw the delivery system and sheath as a single unit completely from the arteriotomy while maintaining guidewire position, do not attempt to pull the delivery system through the remaining length of the sheath.If unable to pull the entire balloon into the sheath, do not attempt to remove the exposed balloon through the entire peripheral vasculature, as there is risk of major complications, conversion to surgery is recommended to remove the system and a surgeon should be in a position to be able to evaluate the situation, based on a medical assessment of the size, tortuosity, and extent of calcification of the peripheral vessels, evaluate the risks and tradeoffs of carefully withdrawing the system into a more peripheral anatomy in order to allow a more localized surgical procedure, consider use of an occlusion balloon to mitigate bleeding risks, especially if there is resistance encountered during withdrawal.If resistance is unacceptably high, convert to surgery rather than using excessive force to pull the sheath/delivery system to a different position, ensure the valve is well opposed.If it is not, you must post dilate immediately with another balloon or delivery system and sheath and take care when crossing the deployed valve to prevent potential embolization.Balloon burst is identified in the commander delivery system risk management worksheet as a potential cause that may lead to procedural delay and withdrawal difficulties.This event reports a balloon burst during thv deployment that has not resulted in a patient harm, or a device failure to perform its function.Also, there was no evidence of product non-conformances or labeling/ifu inadequacies identified in the evaluation.The risk of balloon burst, difficulty withdrawing delivery system through sheath, and associated harms has been reduced as low as possible through design and manufacturing processes.Edwards has provided guidelines and instructions to the physicians in the ifu and training materials/refresher training on how to withdraw catheter, remove sheath, access site closure.Users are informed of the residual risks associated with use of the delivery system and sheath through the potential adverse events section in the instructions for use (ifu) and/or device training materials.The benefits of the system outweigh the risks associated with withdrawing delivery system through sheath.Additionally, the risk of systems components separating and associated harms has been reduced as low as possible through design and manufacturing processes.Edwards has provided guidelines and instructions to the physicians in the ifu and training materials/refresher training on general procedural risks.Users are informed of the residual risks associated with use of the delivery system and sheath through the potential adverse events section in the instructions for use (ifu) and/or device training materials.The benefits of the system outweigh the risks associated with system component separation.A review of the risk management documentation was performed, and 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 balloon burst, difficulty or inability to withdraw system through sheath, and system components separate during use - distal tip were able to be confirmed through the visual inspection of the returned device.However, no manufacturing non-conformance was identified during the evaluation.In this case, 'the 29mm sapien 3 valve ruptured upon deployment.Also, it appears calcium at the stj caused the rupture'.It was noted that patient had calcification present in the landing zone.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.Secondly, 'the tear was transverse making it difficult to retrieve the balloon.The balloon would not enter the sheath and would not enter the common iliac'.The balloon burst likely altered the balloon profile.The altered delivery system made the device more susceptible to be caught on the sheath tip, which subsequently resulted in withdraw difficulty into the sheath.The liner delamination and bunching observed on the sheath are indicative of delivery system catching on the sheath tip.Lastly, 'the balloon nose cone was snared from subclavian and was pulled out'.As a result of balloon burst, the balloon's altered profile may have led to difficulties encountered with withdrawing the delivery system into the sheath.The altered balloon profile and distal portion of delivery system could have got caught in the sheath tip.Subsequently, this may have required excessive manipulation of the devices to overcome the withdrawal difficulties, which may have resulted in separation of the components.Available information suggests that patient (calcification) and procedural factors (withdrawal of burst balloon, excessive manipulation) could have contributed to the 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.Therefore, no corrective or preventative action nor product risk assessment is required at this time.

• Brand Name: 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: 11860139
• MDR Text Key: 252357589
• Report Number: 2015691-2021-03052
• 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: 08/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: COMMANDER DELIVERY SYSTEM UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention