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

Model Number 9750TFX23A

Device Problems Incomplete Coaptation (2507); Insufficient Information (3190); Thickening of Material (4056); Device Stenosis (4066); Central Regurgitation (4068)

Patient Problems Dyspnea (1816); Insufficient Information (4580)

Event Date 02/16/2024

Event Type  Injury  

Manufacturer Narrative

Per the instructions for use (ifu), non-emergent reoperation, emergency cardiac surgery, reoperation, device migration or malposition requiring intervention and device explant are listed as potential risks associated with the device and transcatheter valve replacement procedure.The ifu cautions that long-term durability has not been established for the valve.Regular medical follow-up is advised to evaluate valve performance.Accelerated deterioration of the valve due to calcific degeneration may occur in children, adolescents, or young adults and in patients with an altered calcium metabolism.Valve recipients should be maintained on anticoagulant/antiplatelet therapy, except when contraindicated, as determined by their physician.This device has not been tested for use without anticoagulation.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.Valve reintervention may be due to valve dysfunction (e.G., severe or clinically significant paravalvular leak, central leak, significant malposition, early/late endocarditis, thrombosis, structural valve deterioration or degeneration) and/or other reasons unrelated to the edwards devices (e.G., treatment of other patient comorbidities).During the manufacturing process, all sapien valves (all models) are 100% visually inspected for defects and 100% tested under physiological backpressure conditions prior to release for distribution.Therefore, it is highly unlikely that a manufacturing defect or device malfunction contributed to the event.In this case, despite multiple investigational attempts, it was not possible to obtain additional details regarding this event.Due to limited information, a definitive root cause was unable to be determined at this time.At the time of this report, the information available does not reasonably suggest there was a malfunction of the edwards device or that the use or miss-use of the device caused or contributed to the event.There is no allegation of deficiencies related to the identity, quality, durability, reliability, safety, labeling effectiveness, or performance of this edward device.Should additional information become available, the information will be reviewed, and the file updated accordingly.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 monthly, and any excursions above the control limits are assessed and documented as part of this monthly review.As such, neither a product risk assessment, nor corrective or preventative actions are required at this time.H3 other text : remains implanted.

Event Description

As reported by an edwards lifesciences field clinical specialist, regarding a 23mm sapien 3 ultra valve in the aortic position, approximately 3 years and 3 months post implantation, the patient may received a valve in valve.No other information was provided.

Manufacturer Narrative

The device was not returned for evaluation.Due to the unavailability of the complaint device, engineering was unable to perform any visual inspection, functional testing, or dimensional analysis.Imagery was not provided for review.The reported events were confirmed through medical records.A review of the dhr and lot history did not indicate any manufacturing nonconformances that could have contributed to the reported event.A review of the ifu and training manuals revealed no deficiencies.During the manufacturing process, all sapien 3 ultra valves are 100 percent 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 event.Hypoattenuated leaflet thickening (halt) may be caused by several patient related factors including early valve deterioration (svd) (e.G.Stenosis calcification), non structural dysfunction (e.G.Pannus), or thrombosis.Per medical record, patient had history of hyperlipidemia.Hyperlipidemia is well-known factor that may increase the risk of valve calcification.Calcification could impact the functionality of the valve resulting in leaflet thickening.As such, available information suggests that patient factors (hyperlipidemia) may have contributed to the complaint event.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 are 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.In this case, patient had leaflet thickening, which could narrow the opening (effective orifice area), and obstruct the blood flow, resulting in stenosis.As such, available information suggests that patient factors (leaflet thickened) may have contributed to the complaint event.As the leaflets were thickened, it could affect the function/ suboptimal coaptation of leaflets resulting in leaflet motion restriction.As such, available information suggests that patient factors (leaflets thickened) may have contributed to the complaint event.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.In this case, leaflet thickened with motion restricted was reported, so it could affect the valve leaflets coaptation, resulting in central regurgitation.As such, available information suggests that patient factors (leaflet motion restricted) may have contributed to the complaint event.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.

Manufacturer Narrative

Additional information: b5, a valve in valve was performed.

Event Description

As reported by an edwards lifesciences field clinical specialist, regarding a 23mm sapien 3 ultra valve in the aortic position, approximately 3 years and 4 months post implantation, the patient received a valve in valve.Per medical records review, tte: lvef approximately 60 percent, there is a bioprosthetic valve in the ao position, leaflets appear thickened with restricted motion.Peak av vel of 4.6 m per sec, avmg of 53mmhg, eoa of 0.7 cm2, and mild central ai.Moderate mac.

Manufacturer Narrative

Investigation is underway.

Event Description

Per medical records received on 1/16/2024 tte: lvef ~ 60%, there is a bioprosthetic valve in the ao position, leaflets appear thickened with restricted motion.Peak av vel of 4.6 m/sec, avmg of 53mmhg, eoa of 0.7 cm2, & mild central ai.Moderate mac.

• Brand Name: EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE SYSTEM
• 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: 18860219
• MDR Text Key: 337182382
• Report Number: 2015691-2024-01873
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103201321
• UDI-Public: (01)00690103201321(17)220729
• 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,Followup
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/29/2022
• Device Model Number: 9750TFX23A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2020
• 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: Female