MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE, 26MM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9600TFX26

Device Problems Failure to Capture (1081); Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Date 11/30/2018

Event Type  Injury  

Manufacturer Narrative

Per the instructions for use (ifu), valve embolization is a known potential adverse event associated with the transcatheter aortic valve replacement (tavr) procedure.There are multiple patient and procedural factors that alone or in combination can cause or contribute to aortic embolization, including improper positioning prior to deployment, poor image intensifier angle, poor coaxial alignment of the valve and delivery system, severe septal hypertrophy, minimally or bulky/severely calcified aortic leaflets, preserved ejection fraction, loss of pacing capture, rapid deployment, release of stored tension during deployment, and movement of the delivery system by the operator.The thv training manuals instruct the operator on proper positioning and deployment of the valve, including all procedural and anatomical considerations.Physicians are extensively trained by edwards before they are qualified to use the sapien 3 thv.Training includes patient screening, device preparation, approach, deployment, imaging, procedure-specific training manuals and proctored procedures.The correct alignment and positioning of the device at the point of deployment is emphasized as a key factor to the placement and fixation of the device.Operators are also instructed to use fluoroscopy as the primary method of visualization for positioning and deployment.In patients with high-risk anatomical features for aortic embolization (i.E.Minimal leaflet calcification, severe septal hypertrophy), bav may provide indication of potential balloon movement during valve deployment.There may be cases in which the valve is not able to be deployed at the intended location for various reasons.This may require deploying the valve at a non-target location, typically in the descending aorta.Although, generally well tolerated, the long term effects are not completely understood.The device was not returned as it remains implanted in the patient.However, there was no allegation or indication a device malfunction contributed to this adverse event.In this case, per report, procedural factors (loss of pacing capture during balloon inflation) caused the valve to embolize to the aorta during deployment.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.

Event Description

As reported by our (b)(6) affiliate, during deployment of a 26mm sapien 3 valve in the aortic position, loss of capture during deployment caused the valve to move and embolize into the ascending aorta.The valve was retrieved into aortic arch and expanded.The carotid and radial artery flow was checked and there was no issue.A new delivery system and valve were prepped and deployed at full nominal volume.A normal functioning valve was noted with trace paravalvular leak (pvl).The patient was hemodynamically stable.As reported, the delivery system balloon was prepped with 1ml removed.The aortic annulus area measured 480 mm2.The valve was aligned and positioned without issue.

Manufacturer Narrative

Correction: date of event and date of this report as per australian affiliate, the date of this event was (b)(6) 2018; however, due to global time difference the date the event was captured was on (b)(6) 2018.The correct date of event and date of this report is (b)(6) 2018.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE, 26MM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 8182548
• MDR Text Key: 130984290
• Report Number: 2015691-2018-05461
• Device Sequence Number: 1
• Product Code: NPT
• 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,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/23/2020
• Device Model Number: 9600TFX26
• Device Lot Number: 6041489
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 87 YR