MAUDE Adverse Event Report: EDWARDS LIFESCIENCES US SAPIEN 3 ULTRA VALVE (26MM); AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9750TFX26A

Device Problems Failure to Capture (1081); Device Dislodged or Dislocated (2923)

Patient Problem Aortic Dissection (2491)

Event Date 06/18/2020

Event Type  Injury  

Manufacturer Narrative

Udi number: (b)(4) per the instructions for use (ifu), valve embolization and cardiovascular injury, such as perforation or dissection of vessels, ventricle, myocardium or valvular structures are known potential adverse event associated with the transcatheter aortic valve replacement (tavr) procedure.Ascending aortic dissection may occur when multiple attempts are made to cross the stenotic native valve, and/or when excessive force is used.Physicians are extensively trained by edwards before they are qualified to use the sapien transcatheter heart valve (thv).The thv training manuals provide guidance to facilitate safe crossing of the native valve, including camera projections, handling during advancement, and troubleshooting techniques if difficulty is encountered.As stated, excessive force should not be used when the device has difficulty crossing the stenotic valve.Adding tension to the wire, pulling back the system to re-orient the valve, as needed, and torqueing of the flex catheter may be helpful in solving the problem.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 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.This may require deploying the valve at a non-target location.Although, generally well tolerated, the long-term effects are not completely understood.In this case, there was no allegation or indication a device malfunction contributed to this adverse event.Per the report, the valve embolized due to a loss of pacing capture during deployment, resulting in the valve being implanted in the descending aorta.The aortic dissections were caused by device manipulation while pulling the embolized valve into the descending aorta.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

During implant of a 26mm sapien 3 ultra valve in the aortic position using transfemoral approach, the valve embolized aortic due to loss of capture of the pacer at the end of deployment.The valve was pulled into the mid transverse descending aorta and over expanded making sure there was flow to the left subclavian.There was a dissection in the transverse-descending aorta junction from using the balloon to pull the embolized valve into that position.A second dissection occurred in the descending aorta extending into the right renal, which was caused by the guide wire as a consequence of the embolization.A stent was placed to repair the aorta.A second 26mm sapien 3 ultra valve was prepped and successfully deployed.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: US SAPIEN 3 ULTRA VALVE (26MM)
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 10268721
• MDR Text Key: 200254792
• Report Number: 2015691-2020-12511
• 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,health
• Type of Report: Initial,Followup
• Report Date: 06/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/17/2022
• Device Model Number: 9750TFX26A
• 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: 84 YR