MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS SAPIEN XT; PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED

Model Number 9300TFX

Device Problem Degraded (1153)

Patient Problem Insufficient Information (4580)

Event Date 08/26/2022

Event Type  Injury  

Manufacturer Narrative

Investigation is ongoing.Device information not provided.Device remains implanted.

Event Description

As reported by a field clinical specialist, a patient underwent a successful thv-in-thv procedure with a 23mm sapien 3 ultra valve inside a previous 26mm sapien xt valve in the mitral position.The valve-in-valve procedure is due to the stenosis of the sapien xt valve.

Manufacturer Narrative

A supplemental mdr is being submitted due to engineering evaluation findings.Sections b4, g3, g6, h2, h6: type of investigation, investigation findings, investigation conclusions and h10 has been updated.The device was not returned to edwards lifesciences for evaluation.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 event is not required at this time.The complaint for valve degeneration-deterioration was confirmed based on medical records provided for evaluation.The reported event does not allege a malfunction that could be related to an edwards manufacturing deficiency.A review of the ifu and training manuals also revealed no deficiencies.It should be noted that this was an off-label operation as the thv was implanted in mitral position within pre-existing thv, which was not an indicated use of the sapien xt with the ascendra+ delivery system (ds).During the manufacturing process, all sapien xt 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 event.As reported, -a patient underwent a successful thv-in-thv procedure with a 23mm sapien 3 ultra valve inside a previous 26mm sapien xt valve in the mitral position.The valve-in-valve procedure is due to the stenosis of the sapien xt valve.- per the instructions for use (ifu), structural valve deterioration (wear, fracture, calcification, leaflet tear/tearing from the stent posts, leaflet retraction, suture line disruption of components of a prosthetic valve, thickening, stenosis), and device degeneration are listed in the instructions for use for the thv procedure and are known potential risks associated with the device.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 are 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.In this case, due to insufficient information, a definitive root cause was unable to be determined.No ifu/labeling/training manual inadequacies were identified.Therefore, no corrective or preventative action nor pra is required at this time.

• Brand Name: EDWARDS SAPIEN XT
• Type of Device: PROSTHESIS, MITRAL VALVE, 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: 15439608
• MDR Text Key: 300066139
• Report Number: 2015691-2022-07934
• Device Sequence Number: 1
• Product Code: NPU
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/12/2022

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: 9300TFX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/26/2022
• Initial Date FDA Received: 09/16/2022
• Supplement Dates Manufacturer Received: 09/22/2022; 11/08/2022
• Supplement Dates FDA Received: 10/18/2022; 11/11/2022
• 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
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 81 KG