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

Model Number 9600TFX26A

Device Problem Calcified (1077)

Patient Problem Dyspnea (1816)

Event Date 01/20/2023

Event Type  Injury  

Event Description

Edwards received notification from a field clinical specialist that a patient with a 9600tfx 26mm sapien 3 valve, implanted in the aortic position for approximately 4 years and 6 months is failing due to severe stenosis with mild leaflet calcification.As reported, the patient presented with shortness of breath and increased o2 demands.The patient was not a surgical candidate for open avr.The patient was worked-up for a possible balloon aortic valvuloplasty with transcatheter valve-in-valve as a back-up.However, the procedure has not been scheduled at this time.

Manufacturer Narrative

The investigation is in progress, a supplemental report will be submitted.Device remained implanted.

Manufacturer Narrative

The device was not returned for evaluation as it remained implanted.Therefore, a no product return engineering evaluation was performed.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 the failure mode is not required at this time.The complaint of valve calcification was confirmed from the medical record.Review of dhr did not indicate any manufacturing non-conformances contributed to the reported event.A review of the ifu revealed no deficiencies.An existing edwards' 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' thv valves undergo a process used to reduce calcification variability and lower calcification levels.Clinical results of thv implantation show similar mortality and significantly lower svd 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.Review of medical record revealed that the patient has a medical history of hyperlipidemia and diabetes mellitus, which are well-known risk factors for leaflet calcification.As such, available information suggests that patient factors (hyperlipidemia and diabetes) may have contributed to the reported event.No device or labeling problem was identified during the evaluation.Therefore, no further escalation (capa/scar/pra) is required.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.

Manufacturer Narrative

Supplemental report submitted to include additional information received.The patient underwent a bav procedure with a good result approximately 4 years and 8 months post initial valve implant.A 24mm true balloon was used with gradient reduction from 53mmhg pre to 16mmhg post via echo.

• Brand Name: EDWARDS SAPIEN 3 TRANSCATHETER HEATH VALVE
• 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: 16379184
• MDR Text Key: 309578901
• Report Number: 2015691-2023-10814
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103194357
• UDI-Public: (01)00690103194357(17)200402
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/02/2020
• Device Model Number: 9600TFX26A
• 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
• Date Manufacturer Received: 04/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2018
• 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: 65 YR
• Patient Sex: Female