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

Model Number 9750CM29A

Device Problems Burst Container or Vessel (1074); Material Fragmentation (1261); Difficult to Remove (1528); Detachment of Device or Device Component (2907)

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

Event Date 02/15/2024

Event Type  Injury  

Event Description

As reported by a field clinical specialist (fcs), during a tavr procedure with a 29mm sapien 3 ultra resilia valve in the aortic position, the delivery system balloon burst at the end of inflation.The physicians obtained bilateral groin access, right arterial, left arterial and left venous without issue.Right transfemoral (tf) access was obtained for the esheath+.Pigtail and temp pacer placed on the left side.The 29mm s3ur commander delivery system (ds) entered into the esheath+ without issue.Achieved native valve crossing without issue.During valve deployment, the ds balloon burst occurred at the end of inflation.The team paused to view echo imaging and felt there was no need for post dilation.The team proceeded forward with trying to remove the ds balloon.Partial balloon was pulled back into the esheath+ and resistance was felt.The operator pulled the delivery system into the esheath+ and noticed kinking in the sheath, however continued to pull the system with resistance.The ds balloon was very challenging to remove, and the operators were unable to fully pull the balloon into the sheath.The team pulled the sheath and ds out of the vessel, but the balloon tip and torn portion remained in the vessel at the access point.The vascular team was called for cutdown and vessel repair.The access site required cutdown due to removal of balloon.The patient required 3 units of blood due to the bleeding.The perceived root cause of the vessel tear was the delivery system balloon.The valve is functioning well, and the patient is stable.

Manufacturer Narrative

Investigation is ongoing.

Manufacturer Narrative

A supplemental mdr is being submitted due to device image review, sections g6, h2, h6: device codes have been added to the device codes previously sent.

Manufacturer Narrative

A supplemental mdr is being submitted due to engineering evaluation findings, sections g6, h2, have been updated.Additional codes have been added to h6 component code, type of investigation.Codes were corrected in h.6 investigation findings and investigation conclusions based on investigation completion.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.The device was returned for evaluation.The returned device was visually examined for any abnormalities and the following was observed: the first observation was that there was a bunched-up strain relief.The balloon had a j-hook balloon burst.Additionally, both balloon and distal nose tip had separated from the balloon catheter.The j-hook burst had torn the balloon both longitudinally and radially.The burst balloon had separated at the proximal balloon shoulder.Furthermore, the spring near proximal end was stretched.Stretching of the distal end of sheath liner was observed.The provided imagery was evaluated, and the following was observed: the 3mensio imagery received displayed a calcified sinotubular junction (stj).The burst balloon had separated into a big and small.The big piece contained both balloon and distal nose tip.Additionally, the piece showed the balloon had torn longitudinally and radially.Finally, the balloon had separated from the catheter at the proximal balloon shoulder.Per the technical summary, the ifu, current risk mitigations include design and manufacturing controls, and training manuals have been reviewed, no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.The complaint for balloon burst was confirmed based on evaluation of provided imagery of the burst balloon and the returned device.Available information suggests patient anatomy (stj calcification) likely contributed to the event as the provided 3mensio imagery showed a calcified stj.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 following mechanisms such as puncture, local overstretching, open cell impingement, or stress concentration.The complaint for difficulty or inability to withdraw system through sheath was confirmed based on provided imagery of stretched sheath.Available information suggests procedural factors (withdrawal of burst balloon) likely contributed to the event.As the balloon was burst, the altered balloon profile could have made it more susceptible to catch on the distal end of sheath tip, which would have then led to the experienced retrieval difficulty.The complaint for system components separate during use ' distal tip was confirmed based on evaluation of provided imagery of the burst balloon and the returned device.Available information suggests procedural factors (withdrawal of burst balloon, excessive manipulation) likely contributed to the event.As the balloon was burst, the altered balloon profile could have made it more susceptible to catch on the distal end of sheath tip, which would have then led to the experienced retrieval difficulty.Additional pull force/excessive device manipulation could have been applied to overcome the withdrawal difficulty which then led to the reported separation.The complaint for system components separate during use ' balloon was confirmed based on evaluation of provided imagery of the burst balloon and the returned device.Available information suggests procedural factors (withdrawal of burst balloon, excessive manipulation) likely contributed to the event.As the balloon was burst, the altered balloon profile could have made it more susceptible to catch on the distal end of sheath tip, which would have then led to the experienced retrieval difficulty.Additional pull force/excessive device manipulation could have been applied to overcome the withdrawal difficulty which then led to the reported separation.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.Since no edwards product defects or labeling deficiencies were identified, no corrective or preventative action is required.

• Brand Name: EDWARDS COMMANDER DELIVERY SYSTEM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 18852647
• MDR Text Key: 337070742
• Report Number: 2015691-2024-01664
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103217001
• UDI-Public: (01)00690103217001(17)251213(10)65449174
• 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: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2024
• 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: 65449174
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2023
• 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 Sex: Male