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

Model Number 9600TFX29A

Device Problems Fluid/Blood Leak (1250); Device Stenosis (4066)

Patient Problem Insufficient Information (4580)

Event Date 01/01/2011

Event Type  Injury  

Event Description

Through the review of the medical article ''cardiac reverse remodeling and changes in heart failure indices after transcatheter tricuspid valve replacement in adults with congenital heart disease'', corresponding author abdalla a.Salama , md; omar a.Abozied , mbbs; jason h.Anderson , md; william r.Miranda , md; heidi m.Connolly , md; charles jain , md; allison cabalka , md; alexander c.Egbe , md, mph, ms et al.The following event was identified: a retrospective cohort study of adults (age greater than or equal to 18 years) with chd that underwent tt-vivr and had >6 months of clinical and imaging follow-up at mayo clinic enterprise.There are 39 patients mentioned in the article who had transcatheter tricuspid valve-in-valve replacement (tt-vivr) with the time frame of january 1, 2011, to april 30, 2023.Out of 39, 25 patient had 29 mm sapien valve implanted in the tricuspid valve.All patient had prior surgical tvr with bioprosthesis (27 pericardial bioprosthesis and 12 porcine bioprosthesis) one patient had a surgical tvr replacement with a porcine bioprosthesis for prosthetic valve stenosis and regurgitation from structural failure in a patient with ebstein anomaly that initially received sapien prosthesis.

Manufacturer Narrative

Reference no.2024-00055-02 the valve serial number, implant and explant date are unknown.The investigation is ongoing.The device was used in off-label implantation in the tricuspid position.As there are no specific ifu or training materials related to ttvr procedures, the available training materials were reviewed only for information potentially relevant to the device use.H3 other text : the device was not returned.

Manufacturer Narrative

A supplemental mdr is being submitted for correction and additional information.The following sections of this report have been updated: corrected h.6 investigation conclusions and investigation findings.Added new information to h.6 type of investigation.The device was not returned to edwards lifesciences for evaluation.Without the device returned for evaluation, visual inspection, functional testing and dimensional analysis were unable to be completed.Imagery was not provided for review.A review of the risk management documentation was performed, and no evidence of product non-conformances or labeling/ifu inadequacies were identified in the evaluation.The complaint were unable to be confirmed.Due to unavailability of valve serial number, dhr review was unable to be performed to determine if a manufacturing non-conformance contributed to the complaint.A review of ifu/training materials revealed no deficiencies.During the manufacturing process, all sapien 3 valves are 100% visually inspected for defects and 100% tested for proper coaptation under physiological backpressure conditions prior to release for distribution.Therefore, it is highly unlikely that a manufacturing defect or device malfunction contributed to the reported event.As reported, ''surgical tvr with a porcine bioprosthesis for prosthetic valve stenosis and regurgitation from structural failure in a patient with ebstein anomaly that initially received sapien prosthesis'' per the instruction for use (ifu), valve stenosis is a potential risk associated with bioprosthetic heart valves.Per the valve academic research consortium (varc), valve stenosis can result from a number of factors, including pannus, calcification, support structure deformation (out-of-round configuration), trauma (cardia-pulmonary resuscitation, blunt chest trauma), endocarditis, prosthetic valve thrombosis, and native leaflet prolapse impeding prosthetic leaflet motion.Valve stenosis may result in symptoms such as shortness of breath and decreased exercise tolerance, which may be accompanied by an increased gradient across the valve.This could be due to early calcification of the leaflets, host tissue overgrowth or in rare cases, a non-functioning leaflet.Calcification is a well-recognized failure mode of bioprosthetic valves.The mechanisms for bioprosthetic heart valve tissue calcification is not fully understood.Many factors can contribute to the onset and propagation of calcification including patient related (e.G., patient age, disease state, immune status, and other co-morbidities), pharmacological, and intrinsic properties of the valve itself.Stenosis of an implanted valve may be a manifestation of structural valve deterioration (svd).This term refers to changes intrinsic to the valve, and can include failure modes such as wear, calcification, leaflet tear, stent creep, leaflet disruption, or leaflet retraction.Svd may be mild and not require any intervention or it may be moderate to severe.It can cause the heart to work harder to eject blood from the ventricle.Depending on severity it could be an indication for valve replacement or medical intervention.Per the instructions for use (ifu), valve regurgitation, including paravalvular leak (pvl) and transvalvular leak, are known potential adverse evens associated with bioprosthetic heart valves and the transcatheter valve replacement (thv) procedure.Regurgitation which develops progressively over time can be due to several issues including patient-related factors or structural valve deterioration, such as 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 the functionality of the device by restricting the leaflet motion leading to abnormal coaptation.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, patient had stenosis, which could prevent the leaflets from proper coaptation, resulting in regurgitation.Available information suggests that patient factors (stenosis) may have contributed to the complaint event.Complaint histories for all reported events are reviewed against trending control limits monthly, and any excursions above the control limits are assessed and documented as part of this monthly review.No ifu/labeling/training manual inadequacies were identified.Therefore, no corrective or preventative action nor product risk assessment is required at this time.

• Brand Name: SAPIEN 3 TRANSCATHETER HEART VALVE
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 18508828
• MDR Text Key: 332873763
• Report Number: 2015691-2024-00391
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/12/2024

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 Model Number: 9600TFX29A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/20/2023
• Initial Date FDA Received: 01/12/2024
• Supplement Dates Manufacturer Received: 03/08/2024
• Supplement Dates FDA Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention