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

Model Number 9600TFX29

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

Patient Problems Ventricular Tachycardia (2132); Complete Heart Block (2627)

Event Date 08/24/2020

Event Type  Injury  

Manufacturer Narrative

Per the instructions for use (ifu), arrhythmias are known potential adverse events associated with aortic valve replacement.Post procedure and late ventricular arrhythmias can be associated with patient factors such as poor ventricular function, inadequate coronary perfusion, cardiac tamponade, hypovolemia or electrolyte deficiencies (e.G.Hypokalemia, hypocalcemia, hypomagnesemia).[ventricular arrhythmias can also be associated with significant post procedural bleeding from the ta access site.] this patient population is typically elderly, may be non-operative or high risk, have complex medical histories, multiple co-morbidities, and lower cardiac reserve that can limit their ability to recover from the medical conditions above.In the absence of valve dysfunction or valve related ischemia, post-procedure and late ventricular arrhythmias are highly unlikely to be related to the implanted valve.Per the instructions for use (ifu), conduction system defects (heart block) which may require a permanent pacemaker are potential adverse events associated with balloon aortic valvuloplasty, deployment of the prosthetic valve, and the overall tavr procedure.According to the valve academic research consortium (varc) guidelines, the close anatomical relationship between the aortic valve complex and the branching atrioventricular bundle may provide an explanation for these complications of the tavr procedure.According to literature review, and as documented in a clinical technical summary written by edwards lifesciences, atrioventricular conduction disturbances after tavr are associated with many patient related and procedural related factors, including pre-operative co-morbid status, the degree and bulkiness of aortic valve and annular calcification, inter-ventricular septal thickness, pre-existing electrocardiogram abnormalities, the depth of prosthesis implantation, and the profile of the implanted prosthesis.Unlike conventional avr, where there may be localized trauma due to decalcification of the annulus and/or suture placement in the proximity of the av node or the bundles, tavr may cause conduction abnormalities through mechanical impingement of the conduction system by the prosthesis.The mechanisms of the development of heart block after tavr are well documented and described in the literature.It is also documented that pre-existing heart block is common in patients undergoing tavr or surgical avr and another 4-6 % will develop postoperative heart block, potentially requiring a permanent pacemaker.In this case, there was no allegation or indication a device malfunction contributed to this adverse event.Investigation results suggest/indicate in addition to the procedure, patient factors (advanced age ¿ 83 years, coronary artery disease, ef of 45%) may have contributed to the ventricular tachycardia.There was no allegation or indication a device malfunction contributed to this adverse event.Investigation results suggest/indicate in addition to the procedure factors (pressure from the implanted valve on cardiac structures), patient factors (severe valvular calcification, pre-existing bradycardia) likely contributed to the post implant av block 3rd degree and subsequent pacemaker implant.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.No corrective or preventative actions are required.

Event Description

As reported by our affiliate in (b)(4), a 29mm sapien 3 valve was deployed in the aortic position by the transfemoral approach.The day of the procedure, ventricular tachycardia occurred.A single defibrillation with 200 j was performed.In addition, an arrhythmia occurred.A pacemaker was implanted for atrioventricular (av) block iii degree.The events were resolved.On postoperative day (pod) 5, the patient was discharged.At the time of the report, the patient¿s outcome was good.The native annular diameter measured 0.4cm2 by tte with severe valvular calcification.

• 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 LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 10567139
• MDR Text Key: 207933357
• Report Number: 2015691-2020-13672
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 09/01/2020

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 Expiration Date: 02/19/2022
• Device Model Number: 9600TFX29
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/01/2020
• Initial Date FDA Received: 09/22/2020
• Date Device Manufactured: 03/02/2020
• 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 Weight: 49