MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS INTUITY ELITE VALVE SYSTEM AORTIC VALVE; REPLACEMENT HEART VALVE

Model Number 8300AB27

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

Patient Problems Arrhythmia (1721); No Code Available (3191)

Event Date 02/22/2018

Event Type  Injury  

Manufacturer Narrative

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 required a permanent pacemaker on post-operative day two.Based on the available information, the root cause for the event remains indeterminable.However, it is likely that patient related factors and procedural factors contributed to the event.The device history record (dhr) is pending.A supplemental report will be submitted upon completion.

Event Description

Edwards received information via a clinical trial that a patient with a 27mm pericardial aortic valve developed sick sinus syndrome and a permanent pacemaker was implanted on pod #2 without incident.The outcome was noted as to be resolved.Patient was discharged home on pod #5.

Manufacturer Narrative

The device history record (dhr) was reviewed and showed that this device met all manufacturing and sterilization specifications for product release prior to distribution.No issues were identified that would have impacted this event.Edwards will continue to review and monitor all events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Manufacturer Narrative

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

• Brand Name: EDWARDS INTUITY ELITE VALVE SYSTEM AORTIC VALVE
• Type of Device: REPLACEMENT HEART VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 7802044
• MDR Text Key: 117769269
• Report Number: 2015691-2018-03465
• 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: health professional,other,use
• Type of Report: Initial,Followup,Followup
• Report Date: 07/27/2018

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: 06/22/2021
• Device Model Number: 8300AB27
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/27/2018
• Initial Date FDA Received: 08/21/2018
• Supplement Dates Manufacturer Received: 08/30/2018; 07/23/2020
• Supplement Dates FDA Received: 09/06/2018; 12/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 69 YR