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

Model Number 9600TFX29A

Device Problem Calcified (1077)

Patient Problem Dyspnea (1816)

Event Date 01/16/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Edwards received notification from a field clinical specialist that a patient with a 9600tfx 29mm sapien 3 valve, implanted in the aortic position for 4 years and 10 months, is being worked up for a possible thv in thv.The patient is symptomatic with shortness of breath.This patient is still in the workup stages, so it has not been determined the best intervention for this patient at this time.Recent va tee showed a well seated valve with severe degree of aortic stenosis, right coronary leaflet immobility, leaf and non-coronary leaflet calcification with restricted motion, mild central regurgitation, and a mean gradient of 53mmhg.Prior tte from va in after approximately 1 year after initial tavr, gradients were also rising at that time.Vmax was 3.2 and mean gradient 25.On pod 1 after initial tavr, tte gradient was 12.Of note patient also has some lung issues and currently being treated for mycobacterium avium complex (mac) infection.

Manufacturer Narrative

Supplemental report submitted to include additional information received through follow-up.The patient underwent a valve-in valve procedure.A 29mm sapien 3 was successfully implanted.Updated b7.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 tissue processing, which is used to r educe 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 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.Insufficient information is available for this case.A definitive root cause for calcification noted approximately 4 year and 10 months post-implantation was unable to be determined; however, may be related to patient factors.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.

• 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: 16325721
• MDR Text Key: 309065352
• Report Number: 2015691-2023-10681
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103194364
• UDI-Public: (01)00690103194364(17)191211
• 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: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/11/2019
• Device Model Number: 9600TFX29A
• 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: 03/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2018
• 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 Sex: Male