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

Model Number 9600TFX23

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bradycardia (1751)

Event Date 11/03/2022

Event Type  Injury  

Manufacturer Narrative

Per the instructions for use (ifu), conduction system defects (heart block), arrhythmias, and conduction system defects, (bradycardia, lbbb, rbbb) which may or may not require a permanent pacemaker are potential adverse events associated with balloon aortic valvuloplasty, the use of local and/or general anesthesia, bioprosthetic heart valves, and the thv procedure.Sick sinus syndrome (sss), also called sinus node dysfunction (snd), is an umbrella term for a group of abnormal heart rhythms (arrhythmias) presumably caused by a malfunction of the sinus node, the heart's primary pacemaker.Bradycardia-tachycardia syndrome is a variant of sick sinus syndrome in which slow arrhythmias and fast arrhythmias alternate.It is often associated with ischemic heart disease and valvular lesions.Sick sinus syndrome is more common in elderly adults, where the cause is often a non-specific, scar-like degeneration of the cardiac conduction system.Coronary artery disease, high blood pressure, and aortic and mitral valve diseases may be associated with sick sinus syndrome, although this association may only be incidental.Acquired snd may occur after damage to the sn artery during cardiac surgery or may be due to occlusion, such as after myocardial infarction.Another surgical cause of snd includes sn tissue damage during cannulation of the superior vena cava (svc) for cardiopulmonary bypass or extracorporeal membrane oxygenation (ecmo).Ischemic cardiac arrest may also cause snd.The natural history of snd may be highly variable, although it tends to be progressive.The only effective treatment for patients with chronic symptomatic snd is pacemaker therapy.Slow heart rates or bradycardia have many potential causes including disturbances in automaticity and conduction, medications including general anesthesia, electrolyte imbalances, advanced age, and cardiac diseases.If this cannot be managed with medication, permanent pacemaker implantation may be necessary.In this case, there was no allegation or indication a product malfunction contributed to this adverse event.Investigation results suggest/indicate that patient factors (1st degree av block) and unknown procedural factors may have caused or contributed to this 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.The ifu and training manuals have been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.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 at this time.

Event Description

As reported from a clinical study in (b)(6), during a tavr procedure using a 23mm sapien 3 valve via transfemoral approach, the patient presented with bradycardia.As a consequence, a permanent pacemaker was implanted.The event is resolved.

• Brand Name: 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: 16308904
• MDR Text Key: 308911921
• Report Number: 2015691-2023-10616
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9600TFX23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2022
• 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: 83 YR
• Patient Sex: Female
• Patient Weight: 72 KG