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

Model Number	9600TFX29A
Medical Device Problem Code	Calcified (1077)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/23/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by the field clinical specialist (fcs), approximately 6 years, 3 months, 1 day post transfemoral tavr procedure with a 29mm sapien 3 valve, the valve presented stenosis.The patient underwent a successful valve in valve procedure with a 26mm sapien 3 ultra resilia valve.Per additional information received, the patient presented shortness of breath with a mean gradient of 56.5mmhg and a peak gradient of 97.9mmhg.The valve area/index of the failed valve was 0.54 cm2.The leaflets were calcified with limited mobility.The patient was discharged home.During the valve in valve procedure, the balloon on the 26mm commander delivery system burst circumferentially during valve deployment at full inflation with +1cc.During withdrawal, there were difficulties.However, the balloon was able to be pulled back into the 14fr esheath+ and removed.A new 14fr esheath+ was inserted.The patient was stable and the esheath+ was removed with successful groin closure.The patient was sent to recovery.There was no injury to the patient.Per report, bav was performed pre-implant.Valve alignment was performed in a straight section.
Additional Manufacturer Narrative
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), is a potential adverse event associated with bioprosthetic heart valves.Per a technical summary written by edwards lifesciences, 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.Of these, the fixation process is a relatively minor contributor to calcification for edwards' tissue valves due to subsequent anti-calcification treatments during manufacturing.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 bioprosthesis from calcifying.In this case, there was no allegation or indication a manufacturing non-conformance contributed to this product problem.Although the exact cause and source of the calcification cannot be determined, it is possible patient factors not provided may have caused or contributed to the 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 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.

• Brand Name: SAPIEN 3 TRANSCATHETER HEART VALVE
• Common Device Name: 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: 25216844
• Report Number: 2015691-2026-15331
• Device Sequence Number: 21332523
• Product Code: NPT
• UDI-Device Identifier: 00690103194364
• UDI-Public: (01)00690103194364(17)200606
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P140031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/19/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/06/2020
• Device Model Number: 9600TFX29A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2026
• Initial Report FDA Received Date: 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/07/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown