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

Model Number 9750CM23A

Device Problems Burst Container or Vessel (1074); Difficult to Remove (1528); Material Separation (1562)

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

Event Date 09/08/2022

Event Type  Injury  

Manufacturer Narrative

Investigation is ongoing.Device not yet returned.

Event Description

As reported by a field clinical specialist (fcs), during the procedure of a 23 mm sapien 3 ultra valve in the mitral position via transfemoral approach, during valve deployment the delivery system balloon ruptured.The balloon was fully inflated and per proctor suggestion 2 extra cc's of volume was added to the delivery system.The team attempted to remove the delivery system through the sheath but the distal end would not go into the sheath.The system was then removed as one unit with some difficulty removing the distal end through the skin.Once removed the balloon tip was noticed to be missing.Fluoro confirmed the balloon tip was still in the groin.A small cut down was performed and the balloon tip was removed from the body.

Manufacturer Narrative

Correction to section d9 and h6 per returned device evaluation.The delivery system was returned to edwards lifesciences for evaluation.The returned device was fully evaluated, and the following was observed.Balloon appears radially burst and separated from ds along with nosecone.Catheter tip separated and guidewire adhesive present.Due to the nature of the complaint (balloon burst), no functional testing was able to be performed.The complaint is confirmed through visual inspection.The inflation balloon single-wall thickness was measured along the edges of the burst location.All measurements met specification.A device history review (dhr) was performed and did not reveal any manufacturing nonconformance that would have contributed to this complaint event.A lot history review was performed and revealed no additional similar complaints.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.A review of the risk management documentation was performed, and 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 were confirmed by visual inspection of the returned device.No manufacturing non-conformances were identified during the evaluation.A review of the dhr, complaint history, lot history, and manufacturing mitigations did not provide any indication that a manufacturing non-conformance would have contributed to the complaint.A review of the ifu and training manuals revealed no deficiencies.As reported, ''the delivery system balloon ruptured'' during valve deployment in a surgical bioprosthetic mitral valve.The balloon burst could be potentially from multiple factors (i.E.Calcified annulus/leaflets, additional inflation volume and etc.).While the balloon is sufficiently designed and tested for the rate burst pressure well above their inflation pressure, it is possible that the interaction between the balloon and the struts of the degenerating pre-existing valve can compromise the structure of balloon wall, through mechanisms such as puncture, local overstretching, open cell impingement, or stress concentration.Additionally, per report, +2cc was added to the normal volume for inflation.The prescribed nominal inflation volume is provided in the ifu.Nominal inflation volume for a 23mm commander delivery system is 17ml.It is possible once the balloon was filled volume past the target, it was subjected to pressures high enough to cause the balloon to burst and lead to the reported event.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 into the esheath plus 14f.As a result, additional pull force/excessive device manipulation could have been applied to overcome the withdrawal difficulty which then led to the balloon separation.Review of available information suggests that patient factors (pre-existing valve) and procedural factors (over inflation) contributed to the balloon burst while procedural factors (withdrawal of burst balloon, excessive manipulation) contributed to the withdrawal difficulty and separation.Since no manufacturing non-conformances or labeling/ifu/training deficiencies were identified, no product non-conformance was confirmed, and the complaint occurrence rate did not exceed the applicable trending control limit, no corrective/preventative actions nor product risk assessment (pra) escalation are required.

• Brand Name: EDWARDS COMMANDER DELIVERY SYSTEM
• Type of Device: PROSTHESIS, MITRAL VALVE, 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: 15519740
• MDR Text Key: 300993581
• Report Number: 2015691-2022-08212
• Device Sequence Number: 1
• Product Code: NPU
• UDI-Device Identifier: 00690103207828
• UDI-Public: (01)00690103207828(17)231222(10)64170612
• 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: 12/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/22/2023
• Device Model Number: 9750CM23A
• Device Lot Number: 64170612
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2022
• 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 Outcome(s): Required Intervention
• Patient Sex: Male