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

Model Number 9750TFX26A

Device Problems Fluid/Blood Leak (1250); Fracture (1260); Perivalvular Leak (1457)

Patient Problems Dyspnea (1816); Hemolytic Anemia (2279)

Event Date 01/31/2024

Event Type  Injury  

Manufacturer Narrative

Investigation is still ongoing.

Event Description

As reported by the field clinical specialist, approximately 3 months, 12 days post transfemoral tavr procedure with a 26mm sapien 3 ultra valve, the patient is currently being evaluated for a valve in valve procedure.Per the physician notes received by the valve clinical coordinator, the patient developed hemolytic anemia, and there was concern about the valve and whether there was significant paravalvular leak or a smaller leak but at high velocity chewing up blood cells.The patient was having ongoing complaints of fatigue, shortness of breath, decreased appetite, and weight loss.Tee 2 months post tavr revealed central leak, and repeat tavr ct revealed questionable mild separation of the struts along the noncoronary sinus of valsalva.Per medical records received, the patient was called to discuss options regarding treatment for the paravalvular leakage leading to hemolysis.The recommended treatment options were bav or a vascular plug.However, the patient would like to seek a second opinion from the facility that performed the tmvr.

Manufacturer Narrative

A device history record (dhr) review did not reveal any manufacturing nonconformance issues that would have contributed to the event.The instructions for use/training manuals were reviewed for guidance/instruction involving the devices.Based on the review of the ifu/training manuals, no deficiencies were identified.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 valve strut fracture and central regurgitation were unable to be confirmed due to unavailable of relevant medical record and imagery.During manufacturing, the device undergoes multiple 100% inspections.In addition, the work order underwent functional product verification testing on a sampling basis as a requirement for lot release.These inspections and tests during the manufacturing process support that it is unlikely that a non conformance contributed to the reported complaint.Per the instructions for use (ifu), central regurgitation is a potential adverse event associated with bioprosthetic heart valves and the transcatheter aortic valve replacement (tavr) procedure.There are multiple patient and procedural factors that alone or in combination can cause or contribute to central regurgitation including malposition of the valve, impingement of a leaflet due to the guide wire, over inflation of the deployment balloon, post dilation of the implanted valve, and slow recovery of adequate ventricular flow post valve deployment and rapid pacing.All of these factors have the potential to contribute to suboptimal coaptation of the sapien valve leaflets and cause central aortic insufficiency.Occasionally there are cases where the root cause of the regurgitation cannot be determined.As reported, 'there was significant paravalvular leak or a smaller leak', and 'tee 2 months post tavr revealed central leak'.In this case, the presence of a paravalvular leak could affect the hemodynamic of the blood flow, resulting in central regurgitation.It was because paravalvular leak could decrease the blood back flow pressure, which were required for proper valve leaflets coaptation.So, if the valve leaflets were unable to be fully closed, it could result in central regurgitation, as reported.As such, available information suggests that patient factors (paravalvular leak) may have contributed to the reported event.As reported, 'tavr ct revealed questionable mild separation of the struts along the noncoronary sov.' in this case, no further clarification was received from the site, so 'mild separation of struts' was unable to determine.It was unlikely to refer as frame strut, because frame strut could not have mild separation.Due to limited information, and unavailable of relevant imagery, a definite root cause was unable to be determined at this time.Per the instructions for use (ifu), paravalvular leak (pvl) is a known 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.Per the instructions for use (ifu), hemolysis is a known potential adverse event associated with the thv procedure and the use of the edwards thv devices.Hemolysis is the destruction of red blood cells.There are multiple extrinsic and intrinsic factors including use of extracorporeal circulation, transfusion, infection, tumors, autoimmune disorders, medication side effects, a metabolic abnormality, and red blood cell membrane instability.Normal red blood cells (erythrocytes) have a lifespan of about 120 days.After the lifespan is over the red blood cells break down and are removed from the circulation by the spleen.In some medical conditions, or because of taking certain medications, this breakdown of red blood cells is increased.Medications that have been associated with hemolysis include acetaminophen, penicillin, and other pain medications.Red cells may be destroyed due to defects in the cells themselves.Another cause of hemolytic anemia is break down due to mechanical damage, such as from heart lung bypass or a result of turbulent blood flow pattern and erythrocyte destruction caused by pvl or central regurgitation.Mild, compensated hemolysis associated with prosthetic heart valves is not uncommon.It is usually associated with either structural deterioration or paravalvular leak.Severe hemolysis is rare, however, and usually reflects paravalvular leak.In this case, there was no allegation or indication a product malfunction contributed to this adverse event.Investigation results suggest/indicate patient and/or procedural factors caused or contributed to this event.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 this adverse event is not required at this time.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.Since no edwards product defects or labeling deficiencies were identified, no corrective or preventative action is required.

• Brand Name: SAPIEN 3 ULTRA 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: 18785414
• MDR Text Key: 336282147
• Report Number: 2015691-2024-01363
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/05/2024

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: 9750TFX26A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/31/2024
• Initial Date FDA Received: 02/26/2024
• Supplement Dates Manufacturer Received: 03/29/2024
• Supplement Dates FDA Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2023
• 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
• Patient Age: 80 YR
• Patient Sex: Male