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

Model Number 9750CM29A

Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907); Material Deformation (2976)

Patient Problem Unspecified Vascular Problem (4441)

Event Date 01/25/2024

Event Type  Injury  

Manufacturer Narrative

The investigation is ongoing.H3 other text : discarded.

Event Description

During a tavr procedure using a 29mm sapien 3 ultra resilia valve, the balloon ruptured during valve deployment.The valve was successfully deployed but the delivery system would not come back into the 16 fr esheath.They were able to get most of the balloon into the sheath and then decided to pull the delivery system and sheath out of the groin as one unit.Most of the delivery system and balloon came out except for the distal third of the balloon stuck at the access site.Vascular surgery was called, and they did a femoral cutdown and pulled out the remaining piece of the balloon and nosecone of the delivery system.The vessel was repaired, and the patient left the room in stable condition.Unfortunately, the product was discarded and is not available for return.The perceived cause of the balloon rupture was due to severe calcification of the native leaflets.

Manufacturer Narrative

Correction to h6; component code, type of investigation, investigation findings, investigation conclusion.The events reported are anticipated in the risk management documentation for transcatheter heart valve procedures.A previous investigation into this type of event is captured in an edwards lifesciences technical summary and applies to this complaint.Additional assessment of the failure mode is not required at this time.Due to the unavailability of the complaint device, engineering was unable to perform any visual inspection, functional testing, or dimensional analysis.Imagery provided showed that balloon burst radially with missing material.The reported event of balloon burst, and components separate during use were confirmed empirically based on the evaluation of the provided imagery while withdrawal difficulties were unable to be confirmed as no applicable imagery was provided and no device was returned for evaluation.A review of the dhr did not provide any indication that a manufacturing non-conformance would have contributed to the complaint event.Also, a review of ifu/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 is subject to increased risk of burst in a calcified landing zone.The event description reported, "the perceived cause was severe calcification of the native leaflets".The presence of calcification can create a challenging anatomy for balloon inflation.While the balloons are sufficiently designed and tested to ensure the burst pressure is at or above the rated burst pressure, calcified nodules can compromise the structure of the balloon wall via the following mechanisms such as puncture, local overstretching, open cell impingement, or stress concentration.As the balloon burst, the altered balloon profile could have made it more susceptible to catching on the distal end of the 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.A 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.Additionally, as the balloon burst and there was withdrawal difficulty, it is possible that the additional pull force/excessive device manipulation could have been applied to overcome the withdrawal difficulty which then led to the reported balloon separation.In this case, available information suggests that procedural factors (withdrawal of burst balloon, excessive manipulation) contributed to the balloon separation.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.Since no edwards product defects or labeling deficiencies were identified, no corrective or preventative action is required.

• Brand Name: 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: 18713004
• MDR Text Key: 335482842
• Report Number: 2015691-2024-01039
• Device Sequence Number: 1
• Product Code: NPT
• 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: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9750CM29A
• Device Lot Number: 65435561
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2023
• 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 Age: 71 YR
• Patient Sex: Male