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

Model Number 9600TFX23J

Device Problems Fluid/Blood Leak (1250); Perivalvular Leak (1457); Incomplete Coaptation (2507)

Patient Problem Injury (2348)

Event Date 10/29/2020

Event Type  Injury  

Manufacturer Narrative

The investigation is underway.

Event Description

As reported by an edwards lifesciences affiliate in (b)(6), post deployment of a 23 mm sapien 3 valve in the aortic position via transfemoral approach severe paravalvular leak (pvl) was observed.Post dilation was performed twice and the pvl was reduced to trace however, one of the sapien 3 valve leaflets was observed to be frozen and resulted in central regurgitation.Another 23 mm sapien 3 valve was implanted valve in valve (viv) and resolved the central leak.The patient was in stable condition post procedure.

Manufacturer Narrative

The product was not returned for evaluation.No applicable imagery was provided for review.A device history records (dhr) review did not reveal any manufacturing related issues that would have contributed to the complaint.A review of the lot history revealed no other similar complaints.The instructions for use (ifu), device preparation and the training manual were reviewed for instructions or guidance for proper use of the device and no deficiencies were identified.During the manufacturing pross, the valve is visually inspected and tested several times.During manufacturing, the valve frame component is 100% inspected.During the final inspection, the device underwent 100% inspection by both manufacturing and quality.These inspections and tests during the manufacturing process support that it is unlikely that a non-conformance contributed to the reported complaint.A review of edwards lifesciences risk management documentation was performed for this case.  the reported event is an anticipated risk of the transcatheter heart valve procedure, additional assessment of the failure mode is not required at this time.  the complaints for leaflet motion restricted in patient and valve regurgitation central leak and valve regurgitation pv leak were unable to be confirmed.Due to the unavailability of the device and/or relevant imagery, engineering was unable to perform any visual, functional, or dimensional analysis.A review of the dhr revealed no indication that a manufacturing non-conformance contributed to the complaint.Additionally, a review of manufacturing mitigations supports that proper inspections are in place during the manufacturing process to detect issues relating to the complaint.Review of ifu/training manuals revealed no deficiencies.Per 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.As reported, ¿after the valve was implanted, intracardiac echocardiography (ice) revealed the trivial pvl¿, and ¿the pvl was seen from right coronary cusp (rcc) and it was severe.¿  in addition, noted that the reported valve (first) was deployed at 90/10 (aorta/ventricular).Per training manual, ¿typically final deployed thv position will be around 70/30 to 80/20 (aortic/ventricular).¿ in this case, the valve could be deployed too aorta, compromising the sealing between the valve and target site, and lead to the pvl.As such, available information suggests that procedural factors (valve deployment position) may have contributed to the complaint event.However, a definitive root cause was unable to be determined at this time.During the manufacturing process, all edwards valves are 100% visually inspected for defects and 100% tested for coaptation prior to release for distribution.This makes it highly unlikely that a manufacturing defect or device malfunction would contribute to the event.As reported, ¿the post-dilation was performed twice with nominal volume.After the 2nd post-dilation, central regurgitation was trivial to mild.The pvl was seen from right coronary cusp (rcc) and it was severe.As the frozen leaflet was suspected, guide wire was manipulated to resolve it.However, the condition was not improved and central regurgitation at this point was severe.¿ in this case, the central regurgitation appears to be occurred after post-dilation.Per training manual, central regurgitation is one of the potential risks that can be resulting from post-dilation.The multiple dilations may have caused damage to the valve leaflets, leading to suboptimal coaptation of leaflets and resulted in central leak.As such, available information suggests that procedural factors (post-dilation) may have contributed to the complaint event.However, a definitive root cause was unable to be determined at this time.The complaint was unable to be confirmed.Due to the unavailability of the device, it cannot be determined if a manufacturing nonconformance contributed to the reported event.No labeling/ifu/training inadequacies were identified.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 month review.As such, neither a product risk assessment escalation, nor 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: 10879828
• MDR Text Key: 217710784
• Report Number: 2015691-2020-14574
• 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
• Type of Report: Initial,Followup
• Report Date: 10/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/16/2022
• Device Model Number: 9600TFX23J
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/29/2020
• Initial Date FDA Received: 11/20/2020
• Supplement Dates Manufacturer Received: 12/18/2020
• Supplement Dates FDA Received: 12/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR