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

Model Number 9300TFX23

Device Problems Gradient Increase (1270); Device-Device Incompatibility (2919)

Patient Problems Injury (2348); Patient Problem/Medical Problem (2688)

Event Date 07/14/2020

Event Type  Injury  

Manufacturer Narrative

It is normal to have a small gradient across a prosthetic valve after implant.If elevated, it may indicate obstructed flow across the valve.An increase in gradients may result from patient factors such as hypertrophic cardiomyopathy (hcm) or sub-valvular aortic stenosis.Additionally, an increase in gradients can indicate that a leaflet is not functioning optimally due to calcification or early thrombus formation.In the instance of a bioprosthetic valve in valve implant an increased gradient can be a result of intravalvular regurgitation and is not a result of a valve leaflet malfunction.If mild, these patients will not require intervention and will be followed with serial echocardiography.If significant and results in symptoms, it may require intervention.Per the valve academic research consortium (varc), prosthetic heart valve device success is described as no prosthesis- patient mismatch and mean aortic valve gradient <20 mmhg or peak velocity <3 m/s, and no moderate or severe prosthetic valve regurgitation.Valve-related dysfunction (structural valve deterioration) is described as a mean aortic valve gradient >20 mmhg, eoa <0.9¿1.1 cm2 and/or dvi <0.35 m/s, and/ or moderate or severe prosthetic valve regurgitation requiring repeat procedure (tavi or savr).In the short term, abnormally high gradients may indicate a leaflet that is not functioning optimally, while in the longer term an abnormally high gradient could result from calcification of the leaflets.Abnormally low gradients may be a symptom of regurgitation.In this case, the cause of the increase in gradient across the sapien xt valve was reported to be patient prothesis mismatch and/or not fracturing the pre-existing surgical ring.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 an edwards lifesciences affiliate in (b)(6), approximately 1 year post implant of a 23mm sapien xt valve in a 23mm non-edwards valve in the aortic position, the echocardiogram showed a gradient of 90mmhg due to patient prothesis mismatch.The patient is being treated with warfarin for 6 months, and the plan is to ¿crack¿ the non-edwards valve ring with high pressure balloon.Patient is hospitalized.

Event Description

Additional information: the sapien xt valve was explanted and a non-edwards surgical valve was placed.The patient was reported as 'okay'.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: EDWARDS SAPIEN XT 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: 10365185
• MDR Text Key: 201833887
• Report Number: 2015691-2020-12927
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• PMA/PMN Number: P130009
• 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: 07/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/08/2021
• Device Model Number: 9300TFX23
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• 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