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

Model Number 9750CM26A

Device Problem Burst Container or Vessel (1074)

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

Event Date 02/01/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation is still ongoing.

Event Description

As reported by the field clinical specialist (fcs), during a transfemoral valve in valve tavr procedure with a 26mm sapien 3 ultra valve in a non-edwards valve, the commander delivery system balloon ruptured near the final one to two cc of fluid for a nominal prep.The balloon appeared to be near the tip and also near the other shoulder of the balloon.The delivery system was slowly pulled back into the descending aorta, and there was slight resistance of the balloon as it was pulled into the esheath.The team was able to safely remove the balloon catheter without injury to the patient.

Manufacturer Narrative

The device was not returned to edwards lifesciences for evaluation, however, a device history record (dhr) review was done and did not reveal any manufacturing nonconformance issues that would have contributed to the event.A lot history review was performed and revealed no other complaints relating to the reported event were identified.The instructions for use/training manuals were reviewed for guidance/instruction involving the esheath and delivery system usage.Based on the review of the ifu/training manuals, no deficiencies were identified.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 difficulty to withdraw system through esheath were unable to be confirmed as neither the complaint device nor applicable imagery was provided.The complaint description states, '26mm sapien 3 ultra valve in a non edwards valve, the balloon ruptured near the final one to two cc of fluid for a nominal prep.The balloon appeared to be near the tip and also near the other shoulder of the balloon.The delivery system was slowly pulled back into the descending aorta there was slight resistance of the balloon as it was pulled into the esheath.' as a no additional information was provided, a definite root cause of the balloon burst was unable to be determined.However, it is possible the balloon interacted with the pre existing valve upon deployment.While the balloons are sufficiently designed and tested to ensure the burst pressure is at or above the rated burst pressure, a pre existing valve 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.Review of available information suggests that patient factors (pre existing valve) may have contributed to the balloon burst while procedural factors (withdrawal of burst balloon) may have contributed to the withdrawal difficulty.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.No corrective or preventative actions are 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: 16452554
• MDR Text Key: 310343750
• Report Number: 2015691-2023-11142
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103207835
• UDI-Public: (01)00690103207835(17)240929(10)64645901
• 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: 04/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 64645901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/01/2023
• Initial Date FDA Received: 02/28/2023
• Supplement Dates Manufacturer Received: 04/04/2023
• Supplement Dates FDA Received: 04/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2022
• 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