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

Model Number 9600TFX23A

Device Problem Calcified (1077)

Patient Problem Cardiogenic Shock (2262)

Event Date 08/31/2022

Event Type  Injury  

Manufacturer Narrative

Investigation is ongoing.

Event Description

A report was received by edwards implant patient registry approximately 6 years post implant of a 29mm sapien 3 valve in the aortic position, the valve was explanted and a surgical valve was implanted.Medical records were reviewed and revealed the patient was admitted in cardiogenic shock, biventricular heart failure, pulmonary hypertension, with a failing sapien tavr related to severe aortic stenosis and severe aortic regurgitation.Angio was done and tandem heart was placed.Per medical records "the patient's valve was demolished, heavily calcified.She also had extensive aortic atheromatous disease around her coronary specifically." an emergency transcatheter aortic valve replacement (tavr) removal of sapien valve and surgical aortic valve replacement (savr) was performed.

Manufacturer Narrative

Correction to section h6.The valve was not returned to edwards lifesciences for evaluation.In addition, no relevant imagery was provided for review.A review of the risk management documentation was performed, and 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 was confirmed from medical record.The reported event does not allege a malfunction that could be related to an edwards manufacturing deficiency.A review of the ifu revealed no deficiencies.An existing technical summary written by ew documents the root cause analysis on valve calcification over the time in patient.Per 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.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 did not confirm any manufacturing non-conformances and identified that the proper manufacturing mitigations have been implemented.Additionally, per 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, ''approximately 6 years post implant of a 29mm sapien 3 valve in the aortic position, the valve was explanted and a surgical valve was implanted''.Medical records were reviewed and revealed the patient was admitted in cardiogenic shock, biventricular heart failure, pulmonary hypertension, with a failing sapien tavr related to severe aortic stenosis and severe aortic regurgitation.Angio was done and tandem heart was placed.According to the record ''the patient's valve was demolished, heavily calcified.She also had extensive aortic atheromatous disease around her coronary specifically.'' an emergency transcatheter aortic valve replacement (tavr) removal of sapien valve and surgical aortic valve replacement (savr) was performed.'' while a definitive root cause was unable to determine due to limited information provided, the technical summary indicates that valve calcification is likely related to patient factors.Since no manufacturing non-conformances or labeling/ifu/training deficiencies were identified, no product non-conformance was confirmed, and the complaint occurrence rate did not exceed the applicable trending control limit, no corrective/preventative actions nor product risk assessment (pra) escalation are required.

• Brand Name: EDWARDS SAPIEN 3 TRANSCATHETER HEART 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: 15519901
• MDR Text Key: 300990178
• Report Number: 2015691-2022-08210
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103194340
• UDI-Public: (01)00690103194340(17)170925
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/25/2017
• Device Model Number: 9600TFX23A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2016
• 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: Female