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U.S. Department of Health and Human Services

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

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EDWARDS LIFESCIENCES COMMANDER DELIVERY SYSTEM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED Back to Search Results
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.
 
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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 Key16452554
MDR Text Key310343750
Report Number2015691-2023-11142
Device Sequence Number1
Product Code NPT
UDI-Device Identifier00690103207835
UDI-Public(01)00690103207835(17)240929(10)64645901
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P140031
Number of Events Reported1
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 Number9750CM26A
Device Catalogue Number9750CM26A
Device Lot Number64645901
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 Received02/28/2023
Supplement Dates Manufacturer Received04/04/2023
Supplement Dates FDA Received04/07/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/03/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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