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

Model Number 9600TFX26A

Device Problems Fluid/Blood Leak (1250); Perivalvular Leak (1457)

Patient Problem Aortic Regurgitation (1716)

Event Date 11/10/2020

Event Type  Injury  

Manufacturer Narrative

Udi number: (b)(4).Edwards lifesciences continues to investigate the reported event and a supplemental report will be submitted in accordance with 21 cfr 803.56 when additional information becomes available.

Event Description

As reported through the (b)(6) registry, 1 year and 10 months post implant of a 26mm sapien 3 valve in the aortic position, a 26mm sapien 3 ultra valve was deployed during a valve in valve (viv) procedure.The initial valve was implanted in a final 60:40 aortic/ventricular position.Worsening central aortic insufficiency (cai) and mild paravalvular leak were reported.At the time of the report, the patient was in stable condition.Both valves remain implanted in the patient.No further information is available at this time.

Manufacturer Narrative

Additional information: section f10: device code; section h6: evaluation codes; section h10: narrative text.Additional information received from the implanting physician indicated the initial sapien 3 valve did not fail.The valve had been deployed ¿too low¿ in the annulus, resulting in a leak through the sapien cage/frame.It was reported that the valve skirt was actually in the lvot, not sealing the annulus.The 26mm sapien 3 ultra valve was implanted in the initial valve during a valve in valve procedure to seal the leak.The physician did not indicate there was any central leak of the initial valve.No other issues or complications with the procedure were reported.Per the instructions for use (ifu), valve malposition requiring intervention is a known potential complication 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 ventricular malposition, including improper positioning prior to deployment, poor image intensifier angle, poor coaxial alignment of the valve/delivery system, a narrow, calcified sinotubular junction (stj), minimally or bulky/severely calcified aortic leaflets, 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 ventricular malposition (i.E.Small, calcified stj, minimal leaflet calcification), bav may provide indication of potential balloon movement during valve deployment.Per the instructions for use (ifu), valve regurgitation is a potential adverse event associated with bioprosthetic heart valves and the tavr procedure.Regurgitation which develops progressively over time can be due to a number of issues including patient related factors or structural valve deterioration, including calcification, non-calcific degeneration, leaflet thickening or fibrosis, or a combination of these.Regurgitation may also develop progressively if host fibrotic tissue, or pannus, grows onto the bioprosthetic valve.Pannus, a cause of nonstructural dysfunction, may interfere with functionality of the device by restricting the leaflet motion leading to abnormal coaptation.Per the instructions for use (ifu), paravalvular leak (pvl) is a potential adverse event associated with bioprosthetic heart valves.Paravalvular leak refers to blood flowing through a channel between the structure of the implanted valve and the cardiac tissue, as a result of a lack of appropriate sealing of the valve to the target site.Some pvl is not uncommon post deployment.Many cases are mild to moderate, and either resolve over time or do not cause symptoms.Others may be more clinically significant and require intervention.The mechanism behind worsening or late pvl is not well understood but may be related to cardiac remodeling.In this case, there was no allegation or indication a device malfunction contributed to this adverse event.Based on the limited information provided, the exact cause for the too ventricular deployment of the valve could not be determined.Investigation results suggest/indicate in addition to the procedure, patient factors not provided may have contributed to the initial low placement of the valve.The too ventricular deployment of the valve likely contributed to the worsening regurgitation (central and pvl) reported by the physician.The second valve, deployed in a higher position within the initial valve, corrected the regurgitation issue.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.

Manufacturer Narrative

Corrected inforamtion: section b3 - date of event.The date of the event was corrected to (b)(6) 2020.

• 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: 11251290
• MDR Text Key: 229340540
• Report Number: 2015691-2021-00245
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2020
• Device Model Number: 9600TFX26A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR