MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9750TFX23A

Device Problem Entrapment of Device (1212)

Patient Problem Obstruction/Occlusion (2422)

Event Date 02/24/2021

Event Type  Injury  

Manufacturer Narrative

Investigation is still ongoing.This individual report provides data received from the thv/tvt registry.

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left anterior descending (lad) coronary artery and was easily removable along the wire.The coronary stent was slowly withdrawn within 1mm of the guide catheter which had been abutted against the valve frame) but met resistance.It became apparent that the coronary stent catheter was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s3 cage.The proximal portion of the coronary stent catheter balloon was stuck, and the stent could not be advanced or withdrawn.After spending several hours attempting to remove the devices percutaneously, the operators decided to deploy the stent with 1mm in the left main and a second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

Correction to h6 based on additional information received.The device was not returned for evaluation; however, there was no allegation or indication of an edwards device malfunction.Per the instructions for use (ifu), coronary flow obstruction is a potential adverse event associated with the tavr procedure.The ifu cautions that the safety and effectiveness have not been established for patients with bulky calcified aortic valve leaflets in close proximity to coronary ostia.The ifu instructs the operator to: perform an angiogram with fluoroscopic view perpendicular to the valve; evaluate the distance of the left and right coronary ostia from the aortic annulus in relation to the valve frame height.The edwards thv training manuals advise the operator on pre-procedure assessment of the aortic valve, root, and coronary anatomy.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.In this case, the event appears to be related to patient factors (minimal distance between the native annulus and the coronary ostia) and procedural factors (device manipulation during attempt to remove the non-edwards coronary stent catheter post deployment of the valve).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: EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 11781006
• MDR Text Key: 252430470
• Report Number: 2015691-2021-02818
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103201321
• UDI-Public: (01)00690103201321(17)220827
• 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: 06/28/2021

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: 08/27/2022
• Device Model Number: 9750TFX23A
• Device Catalogue Number: 9750TFX23A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR