MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS INTUITY ELITE VALVE SYSTEM; TISSUE, HEART-VALVE

Model Number 8300AB25

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Arrhythmia (1721); Complete Heart Block (2627); Patient Problem/Medical Problem (2688); No Code Available (3191)

Event Date 03/20/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Peri-procedural arrhythmias, heart block, and other conduction disturbances are common in patients with underlying cardiovascular disease and/or conduction abnormalities.They can be exacerbated with standard perioperative medications, anesthesia, and/or instrumentation of the heart.Temporary pacemakers are inserted in all patients undergoing aortic valve replacement (avr).It is not uncommon for patients to have short term/reversible periods of heart block or arrhythmias following the procedure while their heart recovers from cardiopulmonary bypass.In many cases, the temporary pm is left in the patient for a short time following the procedure and then subsequently removed prior to discharge.Following surgical aortic valve replacement (avr), new-onset bundle branch block has been reported in 16% to 32% of patients and the need for permanent pacemakers in 3% to 8% of patients.The reason for post-operative av block after surgical avr is related to injury to the cardiac conduction system during surgical excision of the adjacent diseased valve and annular tissue.The close anatomical relationship between the aortic valvular complex and the branching atrioventricular bundle explains the possible development of conduction abnormalities following prosthetic aortic valve procedures.Arrhythmias and conduction disturbances are also common after surgical repair or replacement of the tricuspid and mitral valves due to the proximity of the conduction pathways.In this case, the patient developed lbbb and complete heart block post operatively.As reported, there was high suspicion that the lbbb was caused by the placement of the intuity valve due to the fact that this patient had a history of rbbb and became pacemaker dependent as a direct consequence of the lbbb.The root cause of this event cannot be conclusively be determined.However, this event was likely due to patient and/or procedural related factors.There is no indication or allegation of a device malfunction.The subject device is not available for evaluation as it remains implanted in the patient.The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.Edwards will continue to review and monitor all reported events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Event Description

It was learnt that this patient experienced an arrhythmia event after the implantation of a 25mm pericardial aortic valve.The patient had previous history of rbbb.The patient developed new lbbb and complete av block and became pacemaker dependent.The permanent pacemaker implant occurred on pod #11.As reported, there is a high suspicion that the lbbb was caused by the placement of the intuity valve.Due to the fact that this patient already had an rbbb she became pacemaker dependent as a direct consequence of the lbbb.The information was learnt through review of echocardiographic images provided by the customer.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: EDWARDS INTUITY ELITE VALVE SYSTEM
• Type of Device: TISSUE, HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 8318222
• MDR Text Key: 135498383
• Report Number: 2015691-2019-00419
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• PMA/PMN Number: P150036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 8300AB25
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 65 YR