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

Model Number 9300TFX23A

Device Problems Calcified (1077); Degraded (1153); Gradient Increase (1270)

Patient Problems Stenosis (2263); Insufficient Information (4580)

Event Date 06/14/2021

Event Type  Injury  

Manufacturer Narrative

Investigation is still ongoing.

Event Description

Approximately 5 years post deployment of a 23mm sapien xt valve in the pulmonic position, there was a report that patient was presented with stenosis.Patient was brought to the cath lab for re-dilation of the valve for increased gradients.After 6 months, a valve in valve was performed with a 26mm sapien 3 ultra valve.There was no report of any complications with this valve in valve procedure.

Event Description

Upon medical records review, 5 years and 1 week post the implant procedure with a 23mm sapien, a tte reported the pulmonary valve (pv) gradient of 47mmhg and right ventricular (rv) pressure of 94% systemic.Sometime after the tte, the pv gradient decreased to 10mmhg and rv pressure decreased to 51%.Re-expansion of the sapien valve with a 22mm vida balloon was performed.The 4-month tte reported that bioprosthetic aortic valve 23mm in the pulmonary position.There was moderate pv regurgitation.The pv peak/mean gradient was 68/37mmhg.There was moderate pulmonary insufficiency.Based on the increase in sapien pv stenosis, intervention was planned with intent to replace the pv.The patient was presented with re-stenosis of sapien pv with increased gradient.Under general anesthesia, the patient had a 26mm s3 valve in the aortic position via transfemoral approach.The implant was a success without incident.The residual gradient 14mmhg peak systolic and rv pressure 48% systemic.No procedural complications or edwards's device malfunctions were listed.

Manufacturer Narrative

The following report fields have been updated due to additional information received: b5, g3, h6.Device degeneration is a known potential risk associated with the tavr procedure and is listed in the instructions for use (ifu) as a potential adverse event.Structural valve deterioration (svd) may be manifested as stenosis with thickened leaflets.Svd 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 the severity it could be an indication for valve replacement or medical intervention.Tissue calcification is a very common failure mode.The mechanisms for bioprosthetic heart valve tissue calcification is not yet 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.It is widely understood that patients with chronic renal disease and prior history of calcific stenosis of the native valve may be predisposed to bioprosthetic calcification.A very common failure mode is tissue calcification.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.It is widely understood that patients with chronic renal disease and prior history of calcific stenosis of the native valve may be predisposed to bioprosthetic calcification.In this case, there was no allegation or indication a device malfunction contributed to these adverse events.Based on the limited information provided, the root cause for the valve degeneration proximally 5 years and 1 week post valve implant could not be confirmed but may be related to the patient's co-morbidities and/or pre-existing valvular disease process including moderate regurgitation, pv stenosis, and increased gradient.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.

Manufacturer Narrative

The following report fields have been updated due to additional information received: b5, g3, h6.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 (cardio-pulmonary resuscitation, blunt chest trauma), endocarditis, prosthetic valve thrombosis, and native leaflet prolapse impeding prosthetic leaflet motion.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 thrombus formation.It is possible patient factors such as metabolic issues contributed to the valve stenosis.A very common failure mode is tissue calcification.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.It is widely understood that patients with chronic renal disease and prior history of calcific stenosis of the native valve may be predisposed to bioprosthetic calcification.In this case, the cause of the stenosis approximately 5 years and 6 months post valve implant cannot be determined.Information was requested, but not forthcoming.However, with the limited information provided, it may be due to progression of disease process.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

Approximately 5 years post deployment of a 23mm sapien xt valve in the pulmonic position, there was a report that patient was presented with stenosis.Patient was brought to the cath lab for re-dilation of the valve for increased gradients.After 6 months, a valve in valve was performed with a 26mm sapien 3 ultra valve.There was no report of any complications with this valve in valve procedure.The cause of the valve stenosis is unknown as multiple attempts to gather additional information were not forthcoming.

Event Description

Approximately 4 years and 6 months post deployment of a 23mm sapien xt valve in the pulmonic position, there was a report that patient was presented with stenosis.Patient was brought to the cath lab for re-dilation of the valve for increased gradients.After 6 months, a valve in valve was performed with a 26mm sapien 3 ultra valve.There was no report of any complications with this valve in valve procedure.The cause of the valve stenosis is unknown as multiple attempts to gather additional information were not forthcoming.Upon medical records review, approximately 4 years and 6 months post the implant procedure with a 23mm sapien, a tte reported the pulmonary valve (pv) gradient of 47mmhg and right ventricular (rv) pressure of 94% systemic.Sometime after the tte, the pv gradient decreased to 10mmhg and rv pressure decreased to 51%.Re-expansion of the sapien valve with a 22mm vida balloon was performed.The 4-month tte reported bioprosthetic aortic valve 23mm in the pulmonary position.There was moderate pv regurgitation.The pv peak/mean gradient was 68/37mmhg.There was moderate pulmonary insufficiency.Based on the increase in sapien pv stenosis, intervention was planned within 2 months of the 4-month tte with intent to replace the pv.The patient was presented with re-stenosis of sapien pv with increased gradient.Under general anesthesia, the patient had a 26mm s3 in the aortic position via transfemoral approach.The implant was a success without incident.The residual gradient 14mmhg peak systolic and rv pressure 48% systemic.No procedural complications or edwards's device malfunctions were reported.

Manufacturer Narrative

The edwards sapien xt transcatheter valve was not returned for evaluation.The device is not accessible for testing, as the valve is implanted in the patient.No evidence of a product non-conformance or labeling/ifu inadequacies were identified in evaluation.The risk of early valve degeneration has been reduced as low as possible through design and manufacturing processes.Edwards has provided guidelines and instructions to the physicians in the ifu and training materials/refresher training regarding regular medical follow-up to evaluate valve performance.Users are informed of the residual risks associated with use of the valve through the potential adverse events section in the instructions for use (ifu) and/or device training materials.The benefits of the system outweigh the risks associated with early valve degeneration.A device history record (dhr) review was performed and the work orders related to the manufacturing of the devices and components were reviewed that could potentially contribute to the complaint.The work orders did not reveal any manufacturing non-conformance issues that would have contributed to the complaint event.No imagery was provided for review.There is no evidence of device malfunction contributed to the reported event.Since there was no product non-conformance identified, a product risk assessment (pra) escalation is not required.No edwards defect was identified, and no corrective or preventative actions are required.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 (cardio-pulmonary resuscitation, blunt chest trauma), endocarditis, prosthetic valve thrombosis, and native leaflet prolapse impeding prosthetic leaflet motion.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 thrombus formation.It is possible patient factors such as metabolic issues contributed to the valve stenosis.A very common failure mode is tissue calcification.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.It is widely understood that patients with chronic renal disease and prior history of calcific stenosis of the native valve may be predisposed to bioprosthetic calcification.Device degeneration is a known potential risk associated with the tavr procedure and is listed in the instructions for use (ifu) as a potential adverse event.Structural valve deterioration (svd) may be manifested as stenosis with thickened leaflets.Svd 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 the severity it could be an indication for valve replacement or medical intervention.Tissue calcification is a very common failure mode.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.It is widely understood that patients with chronic renal disease and prior history of calcific stenosis of the native valve may be predisposed to bioprosthetic calcification.In this case, complaint was confirmed by medical records.Based on the limited information provided, the root cause for the valve degeneration approximately 4 years 6 months post valve implant could not be determined but may be related to the patient's co-morbidities and/or progression of the pre-existing valvular disease process (tetralogy of fallot).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.

• Brand Name: EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE
• Type of Device: PULMONARY 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: 12148073
• MDR Text Key: 260947769
• Report Number: 2015691-2021-04047
• Device Sequence Number: 1
• Product Code: NPV
• UDI-Device Identifier: 00690103192070
• UDI-Public: (01)00690103192070(17)170917
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130009
• 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,Followup,Followup
• Report Date: 11/08/2021

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: 09/17/2017
• Device Model Number: 9300TFX23A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/14/2021
• Initial Date FDA Received: 07/09/2021
• Supplement Dates Manufacturer Received: 09/03/2021; 09/03/2021; 11/04/2021
• Supplement Dates FDA Received: 09/03/2021; 09/29/2021; 11/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2015
• 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 Sex: Male