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

Model Number 9750CM23A

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

Patient Problem Insufficient Information (4580)

Event Date 12/16/2021

Event Type  Injury  

Event Description

Edwards received notification from a field clinical specialist that during a transfemoral tavr in a preexisting surgical valve, the balloon of the delivery system ruptured during deployment of 23mm sapien 3 ultra valve.The delivery system was pulled back when resistance was met as distal portion of balloon was entering the sheath.The heart team was instructed to stop when resistance was met.The delivery system was advanced and rotated and pull back was attempted again.The delivery system still would not enter the sheath.The operator pulled with additional force when the nose cone was observed to be detaching from the device under fluoro.A vascular surgeon was called.The delivery system was removed from sheath without the nose cone and portion of distal balloon.Under guidance of vascular surgery, a 20fr gore sheath was exchanged and a snare device was used to successfully retrieve the nose cone but resistance was met again.The 20fr sheath, snare and nose cone were removed as a unit.A new 20fr sheath was placed in the femoral artery.The gradients of the 23s3u valve were checked (15mmhg) and felt that the commander balloon was not full inflated before rupturing only about 70 percent.A post dilation was performed with a 24 true balloon.The patient had mild/moderate preexisting calcium within the surgical valve by ct.Calcium on the leaflets was well visualized under fluoro during the case.17ml of volume was used for inflation without addition volume added.The distal portion of the balloon was successfully removed by the vascular surgeon.The valve was functioning well after post dilation.The devices are currently with the hospital risk management and are not available for return.

Manufacturer Narrative

The investigation is ongoing.A supplemental report will be completed upon completion.

Manufacturer Narrative

The device was not returned for evaluation as it was remained implanted/discarded.Therefore, a no product return engineering evaluation was performed.Post-procedural photos were provided and the following was observed: a radial balloon tear, distal tip separation, and flared wings.The device history record (dhr) review did not reveal any manufacturing nonconformance issues that would have contributed to the event.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 of balloon burst, withdrawal difficulty, and distal tip separation were confirmed by the provided images.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.The complaint description states, 'the patient had mild/moderate by ct.Calcium on the leaflets was very well visualized under fluoro during the case.' 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) likely contributed to the balloon burst while procedural factors (withdrawal of burst balloon, excessive manipulation) likely contributed to the distal tip separation.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 (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: 13227561
• MDR Text Key: 283621242
• Report Number: 2015691-2022-03336
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103207828
• UDI-Public: (01)00690103207828(17)230825(10)63947156
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/17/2022

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: 08/25/2023
• Device Model Number: 9750CM23A
• Device Catalogue Number: N/A
• Device Lot Number: 63947156
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/16/2021
• Initial Date FDA Received: 01/11/2022
• Supplement Dates Manufacturer Received: 02/03/2022
• Supplement Dates FDA Received: 02/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2021
• 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
• Patient Sex: Female