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

Model Number 9750CM26A

Device Problems Positioning Failure (1158); Difficult to Remove (1528)

Patient Problems Foreign Body In Patient (2687); Embolism/Embolus (4438)

Event Date 05/18/2022

Event Type  Injury  

Event Description

As reported by fcs, during the procedure to implant a 26mm sapien 3 ultra valve in the aortic position via transfemoral approach, the first delivery system with valve were unable to be advanced into the patient.When the operator attempted to bring the valve back into the esheath, there was withdrawal difficulty of the delivery system and the valve came off the distal portion of the delivery system.The esheath and delivery system were removed while wire was maintained across the sapien valve and a new esheath was inserted in the right femoral artery.A 10mm balloon was then threaded into the sapien valve and inflated in the distal aorta.This deployed the valve enough that a new delivery system was able to pass through the valve, advanced to the distal aortic arch just past the arch vessels and deployed at this non-target location.A new sapien 3 ultra valve was then prepped and successfully deployed in the aortic position.Patient remained stable throughout the procedure.

Manufacturer Narrative

Investigation is ongoing.Device not returned.

Manufacturer Narrative

Update to b4, g3, g6, h2, h6 and h10 codes to reflect no product returned evaluation.As not product was returned, no visual inspection, functional testing or dimensional testing could be performed.A 3mensio was provided by the field.Tortuosity and calcification of access vasculature were seen.Additional product imagery was provided by the field.The delivery system was seen protruding from tear in sheath seam, with the thv not present.Dislodgement of the thv from original position on the delivery system was seen.The work orders related to the manufacturing of the devices and components that could potentially contribute to the complaint did not reveal any manufacturing nonconformance issues that would have contributed to the complaint event.A lot history review of the related work order was performed and revealed no other complaints relating to the relevant complaint codes.As no device was returned and there is no evidence to support a manufacturing/design defect potentially contributed to the complaint, a manufacturing mitigation review is not required.The commander with s3u ifu, the commander with s3u device preparation manual and the commander with s3u procedural training manual were reviewed.No ifu/training deficiencies were identified.A complaint history review on confirmed device complaints (returned and no product returned) from june 2021 - may 2022 for the commander delivery system (all models and sizes) was performed with the relevant codes.Prior closed complaints with any of the codes were reviewed for similar events and root cause identification.Of the root causes identified, procedural factors (excessive manipulation) is potentially applicable to the complaint event.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 valve dislodged was confirmed based on imagery of the device provided by the field.However, a manufacturing non-conformance was unable to be determined as devices were not returned for evaluation.Additionally, a review of the dhr and lot history 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, ''during insertion, the operator encountered some resistance but pushed the valve further, the valve exited the seam of the esheath in the area of the aortic bifurcation/right common iliac.The operators attempted to bring the valve back into the esheath but this caused the valve to come off the distal portion of the delivery system.'' it was observed in provided 3mensio that tortuosity was present in the patient access vasculature.Tortuosity in the access vessel can create non-coaxial angles of advancement and withdrawal of the delivery system, contributing to resistance when attempting to retrieve the delivery system with crimped thv.Additionally, calcification of patient access vasculature can cause constrained sections of patient anatomy that further contribute to non-coaxial advancement and withdrawal angels.The event reported against the sheath (inability to advance through sheath), was likely due to penetration of the delivery system through the sheath liner as observed in imagery of the returned device provided by the field, and further compounded by patient tortuosity and calcification.It is possible that the attempt of withdrawal back through the torn sheath liner, compounded by patient tortuosity and calcification, caused the thv to become caught on the torn sheath liner, and requiring excessive withdrawal force that resulted in the thv dislodgement observed in provided field imagery.A definitive root cause was unable to be determined at this time.However, available information suggests patient (calcification, tortuosity) and/or procedural factors (excessive manipulation) contributed to the reported event.Since a product non-conformance could not be confirmed and no ifu/training manual deficiency was identified, escalation to a pra is not required.Since no edwards defect could be confirmed, no corrective/preventative actions are required.The ifu and training manuals have been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.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: 14674224
• MDR Text Key: 293832260
• Report Number: 2015691-2022-06167
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103207835
• UDI-Public: (01)00690103207835(17)240111(10)64181246
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/11/2024
• Device Model Number: 9750CM26A
• Device Lot Number: 64181246
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2022
• 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