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

Model Number 9600TFX

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

Patient Problem Arrhythmia (1721)

Event Date 01/01/2017

Event Type  Injury  

Manufacturer Narrative

This is one of four manufacturer reports being submitted for this case.Please reference related manufacturer report no: 2015691-2024-03084, 2015691-2024-03085.Citation: abdelrahman i.Abushouk, md, nikolaos spilias, md, toshiaki isogai, md, tikal kansara, md, ankit agrawal, md, essa hariri, md, omar abdelfattah, md, amar krishnaswamy, md, grant w.Reed, md, rishi puri, md, james yun, md, and samir kapadia, md ''three-year outcomes of balloon-expandable transcatheter aortic valve implantation according to annular size''.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 a definitive root cause could not be determined due to limited information received.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.

Event Description

A review of medical article ''three-year outcomes of balloon-expandable transcatheter aortic valve implantation according to annular size'' was performed.The aim of this study was to evaluate the association between the aortic annulus size and tavi clinical and hemodynamic outcomes at three years of follow-up.During a three year follow-up period post tavi with sapien 3 valves of unknown sizes conduction defects were observed in 50 study patients.41 left bundle branch block, 2 right bundle branch block and 7 complete heart block.Four patients required intervention during the follow up period.It is unknown whether the intervention was related to the strokes, mis or the conductions defects.

• 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: 19166261
• MDR Text Key: 340856809
• Report Number: 2015691-2024-03087
• Device Sequence Number: 1
• Product Code: NPT
• 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: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/23/2024

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
• Device Operator: Health Professional
• Device Model Number: 9600TFX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/29/2024
• Initial Date FDA Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: No
• 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): Other