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

Model Number 9610TF26U

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

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

Event Date 11/23/2021

Event Type  Injury  

Manufacturer Narrative

The investigation is in progress.A supplemental report will be submitted upon completion.

Event Description

Edwards received notification from our affiliate in the (b)(6).As reported, this was a tavr procedure with a 26mm edwards sapien 3 ultra transcatheter heart valve.During procedure, while the balloon was being inflated and after the valve has been deployed, the balloon of the delivery system burst.The balloon was fully inflated and valve was successfully implanted with excellent function.While pulling the delivery system with into the sheath, the balloon and the nose cone tore off at the tip of the sheath and was left inside the patient.Attempts were made to use snares to remove the items, but were unsuccessful.It was then decided to do a cut down and remove the items.As per medical opinion, the patient's annulus had no significant calcium, the calcification of the stj could have been the cause.

Manufacturer Narrative

The device was not returned for evaluation.Therefore, a no product return engineering evaluation was performed.The complaints of balloon burst, distal tip separation, and delivery system withdrawal difficulty were confirmed by visual inspection of the provided picture.However, no manufacturing non-conformance was identified during the evaluation.An existing edwards technical summary has been documented for root cause analysis on balloon bursts in a calcified landing zone.A detailed root cause analysis for similar returned balloon burst complaints has been summarized in technical summary.The technical summary provides a rationale as to why it is unlikely that a product defect or manufacturing non-conformance contributed to this type of event, including factors on why deployment of balloons on thv delivery systems are subject to increased risk of burst in a calcified landing zone.As per medical opinion, the calcification of the sinotubular junction could have been the cause of the balloon burst.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 the balloon was burst, the altered balloon profile can be more susceptible to catch on the distal end of sheath tip which would have then led to the experienced retrieval difficulty.As a result, additional pull force/excessive device manipulation could have been applied to overcome the withdrawal difficulty which then led to the reported separation.In addition, the technical summary outlines the extensive manufacturing mitigations in place to prevent this type of malfunction (visual and dimensional inspections, leak testing, and functional balloon burst testing that occurs with every manufactured lot).These inspections and testing further support that it is unlikely that a defect present in manufacturing contributed to the complaint.The technical summary also outlines the instructions for valve deployment.It should be noted that these mitigations are still in place.Review of available information suggests that patient factors (calcification) contributed to the balloon burst while procedural factors (withdrawal of burst balloon, excessive manipulation) contributed to the withdrawal difficulty and separation.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.A manufacturing nonconformance was unable to be determined without a returned device.Available information suggests that patient factors (calcification) and procedural factors (withdrawal of burst balloon, excessive manipulation) likely contributed to the complaint event.Since no edwards defect was identified, no corrective or preventative action is required.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.

• 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
• Manufacturer Contact: 1 edwards way; irvine, CA 92614
• MDR Report Key: 13170183
• MDR Text Key: 285087168
• Report Number: 2015691-2021-06867
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103208078
• UDI-Public: (01)00690103208078(17)230308(10)63675152
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/08/2023
• Device Model Number: 9610TF26U
• Device Catalogue Number: N/A
• Device Lot Number: 63675152
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/23/2021
• Initial Date FDA Received: 01/05/2022
• Supplement Dates Manufacturer Received: 01/13/2022
• Supplement Dates FDA Received: 01/18/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/08/2021
• 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 Outcome(s): Required Intervention; Required Intervention