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

Event Date 10/11/2021

Event Type  Injury  

Event Description

Edwards received notification from a field clinical specialist that during a transfemoral tavr with a 23mm sapien 3 ultra, the balloon of the commander delivery system burst.As reported, during valve deployment the balloon ruptured when it was fully inflated.The degree of calcium was minimal in the landing zone and +2cc extra volume was used.The valve was successfully implanted.There were difficulties withdrawing the delivery system through the esheath.While trying to retrieve the distal part of the balloon tore off.They tried to snare and bring into the sheath.A 20fr gore sheath was introduced into the contralateral side in an attempt to grab distal part of nose cone.A cutdown was performed on the contralateral side.Sheath was removed and distal part of balloon was also taken out through incision.All the missing pieces were removed from the patient.The device is not available for return.The patient was noted to have been discharged.The perceived root cause of the balloon rupture was assumed to be patient anatomy.

Manufacturer Narrative

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

Manufacturer Narrative

The device was returned for evaluation and an engineering evaluation was performed.The device history record (dhr) was reviewed and the work orders did not reveal any manufacturing nonconformance issues that would have contributed to the complaint 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 for balloon burst, distal tip, and inability to withdraw the delivery system through the sheath were unable to be confirmed.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.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.Per the reported event, 'the degree of calcium was minimal in the landing zone and +2cc extra volume was used'.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.Additionally, it was noted that an additional volume of 2cc was added to the balloon.The prescribed nominal inflation volume is provided in the ifu that was documented in the technical summary.It is possible the balloon was overinflated, subjecting the balloon to pressures high enough to cause the balloon to burst.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) and procedural factors (over-inflation) contributed to the balloon burst while procedural factors (withdrawal of burst balloon, excessive manipulation) contributed to the withdrawal difficulty and separation.Since no edwards defect was identified, no corrective or preventative action is required.Additionally, there were no ifu/labeling/training manual inadequacies or manufacturing non-conformances were identified.Therefore, no corrective or preventative actions are required at this time.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: 12760509
• MDR Text Key: 281735993
• Report Number: 2015691-2021-06182
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103207828
• UDI-Public: (01)00690103207828(17)230615(10)63846738
• 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: 12/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/15/2023
• Device Model Number: 9750CM23A
• Device Catalogue Number: N/A
• Device Lot Number: 63846738
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2021
• 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