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

Model Number 9750CM23A

Device Problem Unintended Collision (1429)

Patient Problem Insufficient Information (4580)

Event Date 02/24/2021

Event Type  Injury  

Manufacturer Narrative

Investigation is still ongoing.

Event Description

Per report of medical records review, the patient had a valve in valve (23mm sapien 3 in a 23mm surgical valve) performed in the aortic position via right transfemoral approach.The valve implant was successful with no evidence of central leak or paravalvular leak and a mean gradient of 10mmhg.During valve deployment, as the delivery system balloon inflated, it interacted with the guidezilla guide catheter causing it to prolapse out of the left main.Multiple attempts to advance the guidezilla guide catheter over the coronary stent catheter failed.The commander delivery system was removed.The coronary stent catheter was located in the left anterior descending (lad) coronary artery and was easily removable along the wire.The coronary stent was slowly withdrawn within 1mm of the guide catheter which had been abutted against the valve frame) but met resistance.It became apparent that the coronary stent catheter was entrapped between the old valve cage and the s3 cage.The proximal portion of the coronary stent catheter balloon was stuck, and the stent could not be advanced or withdrawn.After spending several hours attempting to remove the devices percutaneously, the operators decided to deploy the stent with 1mm in the left main and a second stent was deployed overlapping the first stent securing it into the left main coronary artery.After post dilating the stents, the devices were successfully removed.Post operative day (pod) 1 echo findings showed no paravalvular leak or central leak, a peak of 27.25 mmhg, a mean gradient of 16mmhg, and an aortic valve area of 1.62cm2.The patient was discharged home on pod 1.

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 complaint event.A lot history review was performed and revealed no other complaints relating to the reported event were identified.The following instructions for use (ifu) were reviewed: ifu for commander delivery system, device preparation manual, procedural training manual, and edwards s3u w/ commander: valve-in-valve procedural training manual supplement.Based on this review, no ifu/training 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 complaint was unable to be confirmed due to unavailability of returned device and /or applicable imagery.Due to unavailability of the device, engineering was unable to perform any visual, functional, or dimensional analysis.Therefore, a manufacturing non-conformance was unable to be determined.A review of 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 valve deployment, as the delivery system balloon inflated, it interacted with the guidezilla guide catheter causing it to prolapse out of the left main.Multiple attempts to advance the guidezilla guide catheter over the coronary stent catheter failed.' the edwards thv training manuals advise the operator on pre-procedure assessment of the aortic valve, root, and coronary anatomy.There was no imagery provided to review.Physicians are extensively trained by edwards before they are qualified to use the transcatheter heart valve (thv).Training includes patient screening, device preparation, approach, deployment, imaging, procedure-specific training manuals and proctored procedures.The physician is instructed to evaluate this risk early in the patient screening process in all patients.The following factors should be considered: degree of calcification on leaflets, annulus to coronary ostia distance, length of the valve leaflet, width of the valsalva sinuses, movement of the leaflets during bav, patency of coronaries during bav, and expanded height of the intended thv.Per the cer, 'the left main height was low and concern for possible occlusion with the bioprosthetic valve.' it is possible that patient (low left main height) and procedural factors (coronary protection, device manipulation, non-edwards device) contributed to the reported 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 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
• MDR Report Key: 11780985
• MDR Text Key: 252351921
• Report Number: 2015691-2021-02817
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103207828
• UDI-Public: (01)00690103207828(17)220617(10)63249683
• Combination Product (y/n): N
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/17/2022
• Device Model Number: 9750CM23A
• Device Catalogue Number: 9750CM23A
• Device Lot Number: 63249683
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR