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

Model Number 9750TFX26

Device Problem Calcified (1077)

Patient Problem Heart Failure/Congestive Heart Failure (4446)

Event Date 01/30/2023

Event Type  Injury  

Event Description

As reported from our affiliates in canada, a patient with a 26mm sapien 3 ultra valve in aortic position underwent intervention for a valve-in-valve procedure after an implant duration of one year and five months due to calcification leading to stenosis, with mean gradient of 95 mmhg.The patient presented with the "typical stenosis symptoms''.A non-edwards device was implanted successfully within the s3, mean gradient 16 mmhg, by transfemoral approach.The patient did not suffer any injury and was noted as to be discharged at home.A post-dilation would have been the first approach but the blood pressure was too high to allow for a safe maneuver.

Manufacturer Narrative

Investigation is ongoing.

Manufacturer Narrative

Updated h6-type of investigation, investigation findings, investigation conclusions.The device was not returned for evaluation as it remained implanted.The complaint for valve calcification was confirmed based on imagery provided.A review of the dhr provided no indication that a manufacturing nonconformance would have contributed to the complaint event.A review of the ifu revealed no deficiencies.A review of edwards lifesciences risk management documentation was performed for this case.The reported events are an anticipated risk of the transcatheter heart valve procedure, additional assessment of the failure modes is not required at this time.An existing technical summary documents the root cause analysis on valve calcification over the time in patient.Per the technical summary, calcific degeneration is a common cause of bioprosthetic heart valve failures.Many factors contribute to the onset and propagation of calcification.These include patient factors (age, disease state, pharmacological intervention, etc.), mechanical stress related to the valve's hemodynamic performance, and glutaraldehyde fixation of tissue.Edwards' transcatheter heart valves (thv) undergo tissue processing, which is a heat treatment process used to reduce calcification variability and lower calcification levels.Clinical results of thv implantation show similar mortality and significantly lower structural valve deterioration rate compared with surgical aortic valve replacement after 6 years of functioning.Though numerous studies have been conducted on preventive calcification strategies in bioprosthetic heart valves, the causes of calcification are not fully understood and there are still no mechanisms or medical therapies which fully prevent calcification from occurring in bioprosthetic valves.Furthermore, evaluation of reported complaints for valve calcification did not confirm any manufacturing non-conformances and identified that the proper manufacturing mitigations have been implemented.Additionally, per the technical summary, no evidence of a product non-conformance or device malfunction were found in any of the valves returned for these complaints.As reported, "a patient with a 26mm sapien 3 ultra valve in aortic position underwent intervention for a valve-in-valve procedure after an implant duration of one year and five months due to calcification leading to stenosis, with mean gradient of 95 mmhg.The patient presented with the "typical stenosis symptoms"." in this case, the leaflet calcification likely impacted the valve function by reducing leaflet mobility; thus, resulted in stenosis.However, due to limited information provided, a definitive root cause for valve calcification remains unknown at this time.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 corrective or preventative actions are required.

• Brand Name: EDWARDS 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 Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 16418403
• MDR Text Key: 309979821
• Report Number: 2015691-2023-10984
• 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: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/30/2023

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: 9750TFX26
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/30/2023
• Initial Date FDA Received: 02/22/2023
• Supplement Dates Manufacturer Received: 03/30/2023
• Supplement Dates FDA Received: 03/30/2023
• 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: 42 YR