MAUDE Adverse Event Report: EDWARDS LIFESCIENCES COMMANDER DS WITH SAPIEN 3, 26MM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9750CM26A

Device Problems Difficult to Remove (1528); Material Rupture (1546)

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

Event Date 01/26/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.Device was discarded.

Event Description

As reported by the edwards field clinical specialist, during deployment of a 26mm sapien 3 ultra valve, the 26mm commander balloon ruptured fully inflated.The valve was successfully deployed.The withdrawal of the delivery system was within a few minutes after the valve was deployed and after the echo was completed.There was trouble removing the system through the 14f esheath+ and a decision was made to remove the sheath and delivery system as a unit.The patient is stable.The patient's vessel minimum luminal diameter measured 9mm with moderate tortuosity and moderate to severe calcified.Per report, there was moderate calcium in the landing zone but the issue was in the lvot.A bav was performed with a non-edwards balloon.There was no extra volume added to the balloon prior to inflation and there was coaxial alignment as the patient had tortuous anatomy.

Manufacturer Narrative

The commander delivery system was not returned to edwards lifesciences for evaluation.Without the device returned for evaluation, visual inspection, functional testing and dimensional analysis were unable to be completed.A device history record (drh) review was completed and did not reveal any manufacturing non-conformances that would have contributed to the reported 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 and withdraw catheter through vasculature with difficulty or inability to withdraw system through sheath were unable to be confirmed as neither the complaint device nor applicable imagery were returned.Engineering was unable to perform any visual, functional, or dimensional analysis.Therefore, a manufacturing non-conformance could not be determined.A review of the device history did not provide any indication that a manufacturing non-conformance would have contributed to the complaint.A review of ifu and training materials revealed no deficiencies.An existing 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.Case notes provided states that patient had moderate to severe degree of calcification of the landing zone.The presence of calcification can create a challenging anatomy for balloon inflation.While the balloons are sufficiently designed and tested for to ensure the burst pressure is at or above the rated burst 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.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.In this case, a review of available information suggests that patient factors (calcification) contributed to the balloon burst while procedural factors (withdrawal of burst balloon) contributed to the withdrawal difficulty.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 is required at this time.

• Brand Name: COMMANDER DS WITH SAPIEN 3, 26MM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFECIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 16388858
• MDR Text Key: 310083860
• Report Number: 2015691-2023-10874
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103207835
• UDI-Public: (01)00690103207835(17)241108(10)64716965
• 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: 03/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9750CM26A
• Device Catalogue Number: 9750CM26A
• Device Lot Number: 64716965
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2022
• 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 Sex: Male