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

Model Number 9750CM23A

Device Problem Device Slipped (1584)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/09/2022

Event Type  Injury  

Event Description

Per the field sales representative, during a transfemoral tavr procedure of a 23mm sapien 3 ultra valve, there was difficulty advancing the delivery system with valve which resulted in the esheath plus kinking.The esheath plus and delivery system were unable to be withdrawn as one unit.The delivery system had been withdrawn first, which resulted in the valve struts being caught on the leading edge of the expanded esheath plus.The valve stripped off the delivery system and remained in the common iliac.Wire access was maintained, and the valve was deployed in the iliac.A second valve, delivery system, and esheath plus were prepped.The esheath plus tracked through the first deployed valve without any issues and the second valve was implanted successfully.There was a slight dissection in the iliac above the deployed valve.A self-expanding peripheral stent was implanted.Patient was stable.

Manufacturer Narrative

The investigation is ongoing.Device not available for return.

Manufacturer Narrative

A supplemental mdr is being submitted for correction and additional information based on investigation.The device was not returned to edwards lifesciences for evaluation.Without the device returned for evaluation, visual inspection, functional testing and dimensional analysis were unable to be completed.In addition, no relevant imagery was provided.A device history record (dhr) review was performed 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 events relating to the reported event.The instructions for use (ifu)/training manuals were reviewed for guidance/instruction involving the valve and delivery system usage.Per the ifu and training manuals, access characteristics that would preclude safe placement of the sheath such as severe obstructive calcification, severe tortuosity or vessel diameters less than the minimum recommended should be carefully assessed prior to the procedure.The minimum vessel diameter for a 26mm valve is 5.5mm.In addition, the thv can be retrieved through the sheath only before thv deployment (valve is still crimped).Ensure the thv is centered on the flex tip and the delivery system is locked.Verify the flex catheter is complexly unflexed.Retract the thv and delivery system into the sheath and ensure the thv is completely inside the sheath and just past the sheath tip.Ensure the edwards logo on the sheath handle is facing upward.Withdraw the delivery system and sheath as a single unit completely from the arteriotomy while maintaining guidewire position.Do not force the thv into the sheath.If resistance is felt, the thv may be caught on the sheath tip.Stop, advance thv past the sheath tip and ensure thv is centered on the flex tip.Rotate the delivery system before trying again.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 event for valve dislodging off the balloon during withdrawal through the esheath plus was unable to be confirmed as neither the device nor applicable procedural imagery was provided.Due to the unavailability of the device, no visual, functional, or dimensional analysis could be performed.Therefore, a manufacturing non-conformance was unable to be determined.A review of the dhr and lot history did not provide any indication that a manufacturing non-conformance would have contributed to the event.A review of the ifu and training manuals revealed no deficiencies.Per the event description, 'during withdrawal of the delivery system and esheath plus, the valve stripped off the delivery system and remained in the common iliac.The esheath plus and delivery system were unable to be withdrawn as one unit.The physician withdrew the delivery system first which resulted in the valve struts being caught on the leading edge of the expanded esheath plus.Wire access was maintained, and the valve was deployed in the iliac'.Per the case notes, tortuosity and calcification were present in the patient's anatomy.Tortuosity in the access vessel can create non-coaxial withdrawal angles.It is possible that the distal end of the delivery system along with the crimped valve created a non-coaxial withdrawal configuration that could have caused catching at the distal tip of the esheath plus and therefore led to the withdrawal difficulty reported.This interaction, in addition to excessive device manipulation to counter the withdrawal difficulty, may have resulted in the valve dislodging from the balloon.However, without applicable patient/procedural imagery, a definitive root cause is unable to be determined.Based on the available information, patient factors (tortuosity) and/or procedural factors (non-coaxial withdrawal (crimped valve), excessive manipulation) may have contributed to the event.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 product risk assessment (pra) nor 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: 13980366
• MDR Text Key: 290412232
• Report Number: 2015691-2022-04778
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103207828
• UDI-Public: (01)00690103207828(17)230823(10)64098925
• 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: 05/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/23/2023
• Device Model Number: 9750CM23A
• Device Catalogue Number: 9750CM23A
• Device Lot Number: 64098925
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2021
• 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